Yourlawyer.com (Defective Medical Devices News)

Cochlear Implant Lawsuit Not Preempted, Judge Says

Tue, 26 Aug 2008 00:00:00 -0700

A lawsuit against the makers of a cochlear implant can go forward, a federal judge in Texas has ruled, because a Supreme Court decision that gave medical device makers protection from product liability lawsuits does not apply to this case. In her opinion, US District Court Judge Barbara Lynn wrote that preemption was not warranted in the case because “plaintiffs’ strict liability claims are predicated solely on violations of federal law."

In February, the Supreme Court ruled in favor of medical device makers in Riegel vs. Medtronic, Inc., granting them protection from product liability lawsuits involving devices that had been approved by the Food & Drug Administration (FDA). Before the High Court, Medtronic had successfully argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts.

That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

In their lawsuit filed last September against Advanced Bionics and Astro Seal, Scott and Pamela Purcel blamed the companies' cochlear implants for injuries their son received. The Purcels’ suit centers around a single component of the HiRes90k — a feed-thru manufactured by Astro Seal — that was used to connect the device’s internal electrical circuitry to external components. Advanced Bionics issued a voluntary recall of all nonimplanted HiRes90k devices containing Astro Seal feed-thrus in September 2004 because moisture could get into the internal circuitry, which could cause the device to fail.

The Purcels' lawsuit alleges that Advanced Bionics violated federal law when it made the defective cochlear implant. That allegation grew out of an administrative claim filed against Advanced Bionics by the FDA last November. The claim, which was amended in March, accused the company of using components from an unapproved supplier. The company settled with the FDA in July by agreeing to pay a $1.1 million fine, the maximum the FDA can impose on an individual or company. As part of the settlement, Jeffery Greiner, Advanced Bionics’ president and co-CEO, also agreed to pay a $75,000 fine.

Because the plaintiffs' claims involve violations of federal law, the judge wrote that lawsuit does not impose requirements that are additional, or different from, those imposed by the Medical Device Amendments of 1976. As such the lawsuit is not covered by the Supreme Court's ruling in Medtronic vs. Riegel, the judge ruled.

Safety Notice says Liko Universal SlingBar Poses Fall Risk

Thu, 21 Aug 2008 00:00:00 -0700

A safety notice for the Liko Universal SlingBar was issued by Liko AB this past June. According to the notice, various models of the Liko Universal SlingBar could become detached from the mobile lift, putting patients at risk of falling.

The products affected by the Liko Universal SlingBar corrective action include:

Universal SlingBar 350; Product Number 3156074; used in combination with Viking XS, Viking S and Viking M Lifts
Universal SlingBar 450; Product Number 3156075; used in combination with Viking L and LikoLight Lifts
Universal SlingBar 600; Product Number 3156076; used in combination with Viking L and LikoLight Lifts
Universal SlingBar 350 with Quick-release Hook; Product Number 3156084; used in combination with all lifts from
Universal SlingBar 450 with Quick-release Hook; Product Number 3156085; used in combination with Liko, i.e. mobile lifts
Universal SlingBar 600 with Quick-release Hook; Product Number 3156086; used in combination with overhead lifts.

The affected Liko Universal SlingBars bear the serial numbers: 1200101-1245680, 121204-121499, 12222407-12225241.

According to the Liko AB safety notice issued on June 2, when mounted on Viking or LikoLight mobile lifts, a component securing the Universal SlingBar to the lift may experience unanticipated fatigue. In extreme cases this can result in the sling bar becoming detached from the mobile lift. If this were to happen when a patient was being lifted, the patient would risk falling. To date, Liko says it has had no report of personal injuries.

To correct the problem, Liko has launched a field correction program to replace all affected products with a new sling bar design. The company says all sling bars now being delivered from Liko AB are the new design.

Liko AB claims that despite the defective Universal SlingBars, the affected lifting equipment is safe to use, as long as the sling bar passes the inspection described in the June safety notice. If a sling bar does not pass the inspection, or if a customer is not sure of how to perform the inspection, they should contact their national distributor for more information.

NexStent Carotid Artery Stents Recalled by Boston Scientific

Fri, 15 Aug 2008 00:00:00 -0700

Boston Scientific said yesterday that it has recalled its NexStent products because of a defective stent delivery system. The Food & Drug Administration (FDA) has deemed the NexStent recall a Class I recall. Such recalls are for dangerous or defective products that predictably could cause serious health problems or death.

NexStent products are used in patients to treat a blockage (stenosis) in the carotid artery, known as carotid artery disease. The two carotid arteries (located on either side of the neck) supply blood to the brain. The device is used in a procedure called carotid artery stenting (CAS), in which the physician places the self-expanding stent in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.

The stent uses one of two delivery systems called the Monorail and Over the Wire, according to the FDA. The recall applies to the Monorail system as well as the stent itself.

The NexStent recall was initiated because the tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke. If the device malfunctions, emergency surgery could be required to remove the tip. The recall includes NexStent products made from June 2007 to May 2008.

Nearly 2700 NexStent products are involved in this recall. The recall does not affect stents that have already been implanted. That is because the problem caused by the defect only occurs during implantation.

Boston Scientific first made its customers aware of the NexStent products recall via a letter dated June 6, 2008. The FDA said that healthcare professionals and consumers may report any problems with the NexStent system to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Patients with questions about recalled NexStent products should contact their doctors.

"All U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned," Boston Scientific said in a statement.

Heart Stents No Better than Drugs in the Long Run

Thu, 14 Aug 2008 00:00:00 -0700

An international team of researchers just reported in the New England Journal of Medicine that while using drugs alone may take longer than angioplasty or stent surgery to help restore blood flow in patients with clogged arteries, patients fare just as well in the long term. PCI, or percutaneous coronary intervention, is the surgery that offers increased short-term relief for some patients with severe or more frequent chest pain. PCI benefits tend to diminish in time according to the researchers.

The team assessed 2,287 volunteers in 50 U.S. and Canadian medical centers as part of its COURAGE—Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation—study. Last year, the group reported that patients taking medication alone for chest pain known as angina and for heart disease are no more likely to die or have a heart attack during the follow-up period of 30 to 84 months versus those who also received PCI. "COURAGE demonstrates that both treatment strategies can have a profoundly positive effect on patients' health status and suggests complementary roles—optimal medical therapy—as first-line therapy, with PCI reserved for patients who do not have a response or who have severe baseline symptoms," wrote Dr. Eric Peterson of Duke University Medical Center in Durham, North Carolina, and John Rumsfeld of the Denver Veterans Affairs Medical Center, in a commentary.

"You can say to patients, 'you won't be at increased risk if we don't put a stent in that blockage right now,"' said Dr. William Weintraub of Christiana Care Health System in Newark, Delaware, who led the study. Weintraub and his colleagues found that PCI recipients experienced more immediate relief from chest pain and felt fewer physical limitations; however, after one year, that impact began to change and by three years, no meaningful difference could be determined between those receiving PCI and those taking medications.

The team calculated that if all patients received the best drug therapy, adding PCI would only provide significantly improved chest pain relief in about one of every 17 patients; for every 25 patients who received the PCI procedure, only two such patients would experience significantly improved quality of life. Of the patients studied, only about 21 percent of those who initially received drug treatment alone underwent PCI surgery.

In their commentary, Peterson and Rumsfeld did mention that PCI surgery does carry extra risks. For instance, for every 1,000 patients initially treated with PCI surgery, approximately two would die, 28 would suffer a heart attack associated with the surgery, 60 to 90 would show improvement, and at least 800 patients would not experience any difference in response as compared to receiving drug treatment. A cost comparison of the drug and PCI therapies has not yet been compared. "It is difficult to assert that a PCI-first strategy should clearly be adopted routinely in patients with stable angina," they wrote.

Weintraub and several of the other researchers reported having been paid consulting fees and grants from many different drug companies for conducting the research.

Boston Scientific Stent Study Questioned by Wall Street Journal

Thu, 14 Aug 2008 00:00:00 -0700

The Wall Street Journal is reporting that a study used by Boston Scientific in its quest to garner U.S. approval for its Taxus Liberte stent used a flawed equation that favored the device. According to the Journal, had Boston Scientific used one of several other methods of calculation, the Liberte clinical trial would have been a failure.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. The Taxus Liberte Stent is already approved overseas, and it is one of Boston Scientific's best selling stents abroad. The company's Taxus Express is the top seller in the U.S. In considering approval of the Liberte, the Food & drug Administration (FDA) asked the company to show that its anticlogging performance in patients was "non-inferior" to the Taxus Express. Boston Scientific claims that the Atlas study, published in 2006, did just that.

But according to The Wall Street Journal, those claims don't really add up. To reach its conclusion, Boston Scientific used the Wald interval, which has long been criticized by statisticians for exaggerating the certainty of clinical trial results. What's worse, when publishing the results of the 2006 Liberte study, Boston Scientific never bothered to disclose that it had employed the Wald interval.

The Atlas study compared Taxus Liberte to the Taxus Express. According to the findings touted by Boston Scientific, the Liberte's anticlogging performance in patients was "non-inferior" to the Taxus Express. According to The Wall Street Journal, the company said that there was less than a 5% chance that its finding was wrong - a measure known as p-value. In April 2007, in the Journal of the American College of Cardiology, the company's researchers for the first time specified the p-value: 4.87%. Scientists generally regard studies with p-values above 5% to be failures, and medical journals typically won't publish them.

But the Journal did its own analysis of the Liberte study using equations other than the Wald interval and found that study's p-value was about 5.1% -- failing to rule out the possibility that patients getting the Liberte stent will have markedly more artery recloggings than those receiving the Express.

The Journal also sited other problems with the Taxus Liberte study. For one thing, because the Liberte stent uses a design similar to its predecessor, the Express, the FDA allowed the company to conduct an easier test than would be required for a newer product.

The FDA also allowed Boston Scientific to leave out a control group of patients newly implanted with the Express. Instead, Boston Scientific was allowed to compare the Liberte's fresh results with data it had collected on Express patients a few years earlier. Boston Scientific also didn't have to "blind" participants in the study. Patients and doctors were aware that the stent being implanted was the model on trial -- a Liberte. That can lead to a placebo effect, according to the Journal article.

Finally, The Wall Street Journal says Boston Scientific wasn't required to prove that the Liberte was "superior" than a previous treatment, only that it wasn't "inferior" to Express. Even then, Boston Scientific proposed-and the FDA allowed -a benchmark in which Liberte could be up to three percentage points worse than Express.

The FDA is still debating whether or not to approve the Liberte. But it ha given Boston Scientific an "approvable" letter that indicates it eventually will.

Lawsuit Alleges Medical Device Makers Paid Illegal Kickbacks to Doctors

Wed, 13 Aug 2008 00:00:00 -0700

A Pennsylvania medical supply company is suing six joint implant manufacturers over alleged illegal kickbacks to doctors. The lawsuit, filed in U.S. District Court in Pittsburgh on Monday, alleges that the defendants blocked Intermedics-McCullough out of the market despite selling inferior and more costly products by offering kickbacks "for the purpose of gaining exclusive access to the lucrative replacement hip, knee and joint industry and to the orthopedic industry in general."

According to the Pittsburgh Post-Gazette, the lawsuit names Zimmer Inc. and Zimmer Holdings Inc.; DuPuy Orthopedics; and Biomet Inc., all of Warsaw, Ind.; Smith and Nephew Inc. of Memphis, Tenn.; Stryker Orthopedics of Mahweh, N.J.; and Stryker Inc., of Kalamazoo, Mich. as defendants. The lawsuit also names dozens of local doctors as recipients of illegal payments.

Allegations of kickbacks by medical device makers are nothing new. A New Jersey based federal probe completed last year found that the manufacturers named in the Intermedics-McCullough suit made lucrative payments to U.S. physicians between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

Since the settlements were reached, some members of Congress have pushed for laws that would require better disclosure of payments made to doctors. The Physician Payments Sunshine Act, for example, would require companies to disclose all gifts, fees or other compensation of more than $500 a year.

According to the Post-Gazette, Intermedics-McCullough sold replacement hip joints, knees, shoulder implants and other orthopedic and surgical products to local hospitals and orthopedic surgeons. The Intermedics-McCullough lawsuit claims that from 1988 to 2007, the defendants "paid illegal kickbacks and provided numerous forms of illegal payments" to doctors and hospitals, and that Intermedic's sales began to drop after 1996 as a result of those practices.

Among the alleged illegal payments listed in the lawsuit was one in excess of $8 million from Zimmer to Dr. Harry Rubash, formerly of the University of Pittsburgh Medical Center and now chief of orthopedic surgery at Massachusetts General Hospital. In total, the lawsuit lists more than 200 payments, ranging from a few hundred dollars, to the $8,073,997 paid to Dr. Rubash.

Massachusetts Governor Deval Patrick Signs A Health Bill with Strong Gifts-to-Doctors Rules

Tue, 12 Aug 2008 00:00:00 -0700

According to a recent Associated Press report, Massachusetts Governor Deval Patrick just signed a bill created, in part, to help reduce that state’s increasing health care costs. The bill will require “hospitals and doctors to adopt a statewide electronic records-keeping system by 2015” and “mandates hospitals report all hospital-acquired infections and bans them from charging for so-called ‘never events’ like wrong-side surgeries.”

Of particular importance, though, is another aspect of the bill that requires pharmaceutical companies and medical device manufacturers to report all gifts to doctors that exceed $50. Trinkets, samples, food and drinks, trips, and other gifts have long been an accepted part of the medical profession. Earlier this year, Christopher A. Viehbacher, president for North American pharmaceuticals at GlaxoSmithKline, wrote to Governor Patrick and Speaker Salvatore F. DiMasi of the state’s House, suggesting his company might not invest as much in Massachusetts if political developments” worked to “devalue” its assets. Viehbacher was writing in response to a proposed gift ban that would make Massachusetts “the most hostile state in the nation when it comes to biopharmaceutical sales.” Now, in response to the bill, some companies claim that the bill’s gift language is so “all-encompassing” it will be impossible for them to conduct research in the state. Also according to the AP, “the national Biotechnology Industr
y Organization slammed the measure.”

Meanwhile, gift-giving practices are changing and last month, gifts that pharmaceutical companies have been giving doctors were banned from drug maker’s marketing campaigns under a new voluntary guideline. The industry’s Code on Interactions with Health Care Professionals—written by the Pharmaceutical Research and Manufacturers of America, the industry’s trade association—will ask chief executives of large drug makers to certify in writing that “they have policies and procedures in place to foster compliance with the code.”

Extravagant gifts given to doctors by industry, such as golf vacations and expensive dinners, have been sharply criticized as influencing doctors' prescribing habits. Industry says such gestures are part physician education; however, critics say these practices sully independent decision-making. "Transparency brings about accountability and benefits everyone, consumers most of all," said Senator Chuck Grassley, an Iowa Republican.

The drug industry last updated its marketing code in 2002, when it banned “dine and dash” events in which drug makers provided free take-out dinners, Christmas trees, and gas to doctors who agreed to listen to brief sales pitches. That code also banned golf outings and free tickets to sporting events. None of those rules apply to biotechnology or medical device makers, many of which continue to give expensive gifts and resort vacations to high-profile physicians. And, last year, five medical device makers settled a U.S. Justice Department investigation over gifts and payment practices. Four of them—Zimmer Holdings Inc., Johnson & Johnson's DuPuy Orthopedics, Smith & Nephew, and Biomet Inc.—agreed to pay a combined $311 million as part of the settlement. The fifth company, Stryker Corporation agreed to change its practices and was not fined.

According to the AP, Senate President Therese Murray, one of the bills champions, said the new law is critical to the success of the state’s landmark health care law.

Levitronix Recalls CentriMag Extracorporeal Blood Pumping System

Mon, 04 Aug 2008 00:00:00 -0700

Levitronix has issued a Class I recall for its CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles. The defective medical device was distributed from the manufacturer in Switzerland to distributors world-wide including the United States. The company manufactured and distributed these products from January, 2001 through March, 2008.

Levitronix has issued the recall because use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.

The CentriMag Blood Pumping System (consisting of the blood pump and console) is used to provide short-term (up to six hours) extracorporeal (that is, outside the body) circulatory support during cardiac and other types of surgeries such as liver transplants. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure.

Levitronix issued a voluntary device correction letter on March 17, 2008, to its U.S. distributor and requested that they contact their customers. On July 24, 2008, the firm updated their March 17, 2008, correction letter. The revised letter :

informed their customers not to use Valleylab Force FX-C or SSE2L electrosurgery device with the firm’s CentriMag Blood Pumping System; and,
included a new warning related to the use of the Valleylab device .

More information about this recall is available at: http://www.levitronix.com/Documents/Medical_us/Dear_Doctor-Final.pdf . Patients with questions may call Levitronix at 1-866-487-2837.

Zimmer Durom Cup Problems Highlight Need for Joint Registry

Tue, 29 Jul 2008 00:00:00 -0700

Hundreds of patients receiving Zimmer Durom Cup hip implants in the U.S. have been experiencing serious problems since the device was introduced in 2006. But it wasn't until this past April, when a prominent surgeon went public with his concerns about the Durom Cup, that physicians learned of the widespread nature of the complaints. Now, patient advocates are calling for the creation of a national database, called a joint registry, that tracks how patients with artificial hips and knees are doing. Such a system, they argue, would quickly alert doctors and federal regulators to devices that have a high failure rate, possibly sparing tens of thousands of patients from severe, painful injuries.

The Durom Cup has been implanted in more than 12,000 U.S. patients since its introduction. The Durom Cup was designed for use in young, active patients who are likely to outlive a conventional hip prosthesis. But last year, Dr. Lawrence Dorr, a highly experienced orthopedist and Zimmer consultant, realized something was very wrong with the Durom Cup.

Within months of receiving the component, many of Dr. Dorr's patients were back in his office, suffering from crippling pain. X-rays of patients who received defective Durom Cups showed that the socket was separating from bone, rather than fusing with it. For patients, who had been told their new hips might last 15 to 20 years, the defect meant they would have to undergo an additional excruciating surgery to have their implant replaced.

Dr. Dorr took his concerns to Zimmer in early 2008, but he was ignored. The company actually tried to blame Dr. Dorr's surgical technique for his patients problems - despite the fact that he has decades of experience doing hip implants. In frustration, Dr. Dorr took his concerns to the American Association of Hip and Knee Surgeons, and found that many other surgeons had similar experiences with the Durom cup. Finally, Zimmer bowed to the pressure created by Dr. Dorr and began an investigation.

Zimmer's investigation revealed that at some clinics, the Durom Cup failure rate was higher than 5 percent. Finally, in July 2008, Zimmer suspended sales of the defective component.

Critics argue that it never should have taken so long for the Durom Cup's problems to become apparent. And in many countries it would not have. Those countries, including Australia, Britain, Norway and Sweden, use joint registry databases to track the performance of artificial joint components. If the U.S. had such a database, Zimmer might have been forced to take the Durom Cup off the market long ago.

According to The New York Times, The Food and Drug Administration is charged with monitoring devices like artificial joints. But that system is often overwhelmed by the vast number of products it monitors and because doctors often do not report problems. Medicare, which pays for about half the hip and knee implants in this country, rebuffed a proposal two years ago from a medical group to support a joint database. It said it was not the agency’s job to gather such data — despite the considerable savings in taxpayer dollars that might come from reducing the number of do-over surgeries.

There are many reasons given for the failure of the U.S. to create a joint implant registry, ranging from the fragmentation and expanse of the healthcare system to the expense involved in such an effort. However, some critics believe a more sinister force is at work - specifically the financial arrangements between implant makers and many orthopedic surgeons. In any registry system, it would be up to physicians to report device problems. Some physicians might be reluctant to report problems with a device if they are receiving compensation from its manufacturer.

If such attitudes are blocking the creation of a joint implant registry, it would not be the first time surgeons were influenced by the payments they receive from implant makers. Last year, several major manufacturers, including Zimmer and Smith & Nephew, agreed to pay $310 million to settle civil charges and resolve a Department of Justice investigation into whether the firms paid illegal inducements to get some doctors to use their products.

Durom Cup Hip Device Sales Halted Over Questionable Design

Thu, 24 Jul 2008 00:00:00 -0700

The nation’s biggest producer of orthopedic devices says it is suspending sales of an artificial hip component that some say is failing at high rates. Zimmer Holdings, based in Warsaw, is also lowering its earnings outlook due to the suspension; shares fell sharply yesterday. The Durom cup has been implanted in over 12,000 patients since it was first sold in the United States in 2006.

Doctors have been voicing complaints in recent months that the Zimmer devices—a hip socket known as the Durom cup—was failing in their patients. In those cases, the patients were required to undergo replacement surgery. Zimmer said its investigation determined that the Durom cup was not defective and that even some experienced surgeons found it difficult to implant the device. Zimmer said it expected to resume sales once it initiated specialized training for doctors.

Zimmer said it expected general need for early replacement of the device in patients to be low; however, Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures going forward.

Zimmer said the sales halt would cut $20 to $30 million from its sales estimates and that its expected earnings for the year would be $4.05- $4.10 a share, down from its earlier forecast of $4.20-$4.25 a share. Bruce Nudell, an analyst at UBS who covers medical devices, said that Zimmer had not issued any warnings that sales would be halted. “They had given hints that there would not be a recall but this came as a surprise,” Mr. Nudell said.

Problems with the Durom cup became known in April when a Los Angeles surgeon, Dr. Lawrence Dorr, publicly warned other orthopedists about cup failures he was hearing about from his patients. At that time, Zimmer said it would initiate an investigation but that it saw no reason to take other action, such as halting sales. Zimmer cited European data that indicated that the Durom cup was doing well there; however, the version of the Durom cup used outside the US is a bit different from the one used in the US. Additionally, while US doctors use the Durom cup in traditional hip replacement surgeries, surgeons in other countries use the device in a relatively new kind of hip surgery known as resurfacing, which involves different surgical techniques.

Zimmer, which announced the sales suspension late Tuesday, said its investigation found that using the cup required a higher degree of precision. Dr. Dorr, who said he had stopped using the device last year, said he did not plan to start reusing it. “It is a bad design,” he said. Mr. Nudell, the analyst, said other doctors were happy with the cup, but he expected Zimmer might see a 50 percent drop in the product’s use when sales resumed.

As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the surgical process that is used in Europe with the Durom cup. That decision will put Zimmer further behind competitors that already have such products on the American market.

Anika Therapeutics Warned for Conditions at Massachusetts Medical Device Plant

Wed, 23 Jul 2008 00:00:00 -0700

Anika Therapeutics, the maker of medical devices used to promote the protection and healing of bone, cartilage and soft tissue, has received a Food & Drug Administration (FDA) warning letter about manufacturing problems uncovered during a March inspection of its plant in Woburn, Massachusetts. Ankika makes Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovisc medical devices, as well as the Hyvisc prescription animal drug at the Woburn plant.

In its letter dated July 2, the FDA said that an inspection of the Anika plant revealed that devices made there were adulterated because the methods, facilities and controls used for their manufacture, packing, storage, or installation are not in conformity with the current Good Manufacturing Practice requirements. Among other things, inspectors visiting the plant in March found that:

The quality department did not observe critical steps in the manufacturing process of products or take environmental monitoring samples to monitor the aseptic manufacturing operations. Inspectors also observed that there was not a basic hand washing sink outside the plant's sterile gowning room, even though Anika's own standard operating procedure requires hand washing to be completed.
The environmental monitoring program did not provide meaningful information on the quality of the aseptic processing environment and ancillary areas used in the manufacture of Amvisc, Staarvisc II, Shellgel, Amvisc Plus, and Orthovisc.
Failure to establish and maintain procedures for implementing corrective and preventive actions, including investigating the cause of nonconformities relating to product, processes, and the quality system.
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.

Anika has 15 working days from the date it received the letter to respond to the FDA. The letter stated that failure to promptly correct all violations could result in legal action being initiated against Anika by the FDA without further notice. These actions include, but are not limited to, seizure, and/or injunction and, with respect to the device violations described in the letter, could include civil money penalties.

Dearth of Pediatric Medical Devices Puts Children at Risk

Mon, 21 Jul 2008 00:00:00 -0700

According to Ziyad Hijazi, chief of pediatric cardiology at Rush University Medical Center, and other doctors, children receive worse treatment in the United States, and have even died, because pediatric medical devices are not approved. Hijazi travels annually with two or three children ad their families to Jordon for heart operations where medical devices not approved for use in the United States are available.

Hijazi implanted an amplatzer muscular VSD to close a hole between the lower chambers of the heart in a child from Massachusetts. The device was manufactured by Minneapolis-based AGA Medical and was available for nine years in Jordan before finally being approved in the US in 2007. Hijazi said over 90 percent of the medical devices he uses on children are "off-label"--approved by the U.S. Food and Drug Administration (FDA) for other uses, such as adult use. "We take responsibility as physicians for using unapproved devices on kids," he said.

In the years 1989-2000, only one stent—a device that props open heart vessel walls—was appropriate for pediatric use, said Thomas Forbes, director of cardiac catheterization at Children's Hospital of Michigan in Detroit. "In the '90s, we lost lives in the cath lab. Patients have died on the table because we were using stents that were made for adults and weren't flexible enough," Forbes said. Having to use adult-sized devices on children can be the difference between "potentially dangerous care and very good care," he said. Three stents can be modified for pediatric use; none are approved for such use in the US, Forbes said. Other pediatric specialists voice similar complaints, saying they either use devices approved for adults or hand-make their own.

Companies often focus on adult-sized devices because the market is bigger. Also, heart diseases in children, are likelier to be congenital and rare; in adults they are more likely to be progressive, and common.

Meanwhile, a law signed late last year provides financial incentives to companies for making devices for children; however, those companies must also track patients at their own expense. "It's a paperwork nightmare. They have to commit resources and follow these patients forever," Forbes said. There are other issues and some solutions, for instance a significant tax credit for research and development in this area, but that is not being discussed, Federici said. Richard Ringel, a pediatric cardiologist at Johns Hopkins Hospital, said he is awaiting the next innovation in cardiovascular medicine: Stents that dissolve inside the body "… do you think Johnson & Johnson is going to be interested in doing this for babies? No, they want to do it for (adult) coronary patients because the numbers are so much larger," Ringel said.

"Development (of pediatric devices) is time-consuming, there are regulatory hurdles, and how do you recoup your investment? The math generally does not work," said Edwards Chairman and Chief Executive Michael Mussallem, who is president of AdvaMed, who added that it comes down to economics and physicians are just used to getting by with what they have.

Use of Coated Stents on the Rise, But How Safe Are They?

Wed, 16 Jul 2008 00:00:00 -0700

Experts disagree on whether stent science is moving too fast and doctors are concerned that blood clots can form at the site of drug-coated stents long after implantation. Now, it seems, drug-coated heart stent implantation is on the rise. Last month, 73 percent of all stent procedures in the U.S. used a coated stent, up from 62 percent in December, the lowest level in several years. The figures came from Goodroe Data Warehouse unit of VHA Inc., of Irving, Texas, and were based on a survey of 60 U.S. hospitals.

Coated stents accounted for the vast majority—approximately 88 percent—of the U.S. stent market about two years ago; however, in 2006, some studies sparked controversy in the stent market and suggested coated stents could result in reclogging and the formation of often-deadly clots years after implantation. Because of this, revised guidelines from medical societies and proposals by the Food and Drug Administration (FDA) to improve standards on future stents were prompted and coated stent sales tumbled through 2006 and 2007. This decline worsened when a study was released in March 2007 that questioned the efficacy of stents versus drug therapy.

Stents are tiny wire-mesh tubes that prop open arteries once doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following balloon angioplasty procedures. Bare-metal stents tend to re-clog more often than drug-coated stents, so physicians are quick use drug-coated stents, even in those patients with complex heart disease, not the patients in whom the devices were tested. In either case, stents are implanted to maintain arterial blood flow. About one million Americans are implanted with stents annually with the most elaborate models costing about $2,000; uncoated, bare-metal stents, sell for less than half that.

Scar tissue causes stents to re-close in about one in five patients, who then require a follow-up procedure to remove and replace the device. Without the procedure, the patient can suffer a heart attack, said Dr. Laura Mauri, an assistant professor of medicine at Harvard Medical School and Brigham and Women's Hospital, in Boston. Drug-coated stents, which were approved by the FDA in 2003, work to prevent too much scar tissue from forming; however, research indicates that the drug can increase the risk of too little scar tissue forming and a blood clot appearing in the stent. "If not enough scar tissue forms to cover the stent, the metal can create a blood clot on its own," said Dr. Jack Tu, a senior scientist at Canada's Institute for Clinical Evaluative Sciences and a professor with the University of Toronto. "It's a fine balance. You want some scar tissue to form around the stent, but you don't want too much to form.

"People initially had a wave of shock" over the safety concerns, said William O'Neill, a cardiologist at the University of Miami medical school. Some doctors advise stent patients to take anti-clotting drugs indefinitely, or at least until more is known about the clotting risk, compared with J&J's initial recommendation of only three months.

Medtronic, Stryker Bone Graft Products Linked to Serious Complications

Wed, 02 Jul 2008 00:00:00 -0700

Off-label use of Medtronic Inc.'s InFuse Bone Graft and Stryker Corp.'s OP-1 Implant and OP-1 Putty have been linked to potentially fatal complications, according to the Food & Drug Administration (FDA). The agency says it has received 38 reports over the past four years of complications when these recombinant human Bone Morphogenetic Protein (rhBMP) products were used in cervical spine (neck) fusion surgeries - an unapproved use of the products.

The FDA says that the complications involve swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. The agency said severe dysphagia following cervical spine fusion using rhBMP products has also been reported in medical literature.

Though the cause of these reactions has not been determined, the FDA says that the proximity of the cervical spine to airway structures in the body contributed to the seriousness of the events reported and the need for emergency medical intervention. Most complications occurred between 2 and 14 days post-operatively with only a few events occurring prior to day 2. When airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly second surgeries to drain the surgical site.

The FDA has advised that doctors use rhBMP products only for approved treatments. Those interested in using the products for neck fusion surgeries should consider enrolling as investigators in clinical trials currently underway to investigate the safety and effectiveness of these products when used in neck fusion surgery.

The FDA also cautioned that patients treated with rhBMP in the cervical spine should know:

the signs and symptoms of airway complications, including difficulty breathing or swallowing, or swelling of the neck, tongue, mouth, throat and shoulders or upper chest area
that they need to seek medical attention immediately at the first sign of an airway complication
that they need to be especially watchful 2 -14 days after the procedure when airway complications are more likely to occur

Sage Products Recalls Medical Device for Bacterial Contamination

Tue, 01 Jul 2008 00:00:00 -0700

Sage Products Inc. has issued a recall of some lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation because it could be contaminated with the bacteria Burkholderia cepacia (B. cepacia). Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement.

According to the company's recall notice, the defective product was shipped to U.S. hospitals and medical centers nationwide between April 28 and June 19,2008. This voluntary recall of Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation, is limited to the Product Code Numbers and corresponding Lot Numbers listed below:

Product Code    Lot Number
        9705             10722
        9705            10729
        9706            10718
        9707            10357
        9707            10365
        9707            10641
        9707            10672
        9707            10753
        9707            10755
        9707            10944

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. The intended application of the 2% CHG Cloth product is topical, for the skin only, and is not for oral or internal use. So far no illnesses have been reported in relation to this recalled device.

B cepacia has been implicated in product recalls in the past. In May, Hydrox Labs in Elgin, Illinois issued a voluntary recall of Cardinal Health-labeled alcohol-free mouthwash due to contamination with the bacteria. In 2005, the Centers for Disease Control (CDC) was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash. In 2004, the CDC was notified of a voluntary recall of over-the-counter nasal spray due to contamination with B. cepacia complex.

In order to prevent this situation in the future, Sage Products has stopped accepting shipments of bulk 2% CHG solution from its outside supplier. The company says new product will be available for shipment as soon as July 7, 2008.

Push on for Hip, Knee Implant Makers to Disclose Doctor Payments

Tue, 01 Jul 2008 00:00:00 -0700

Companies that make joint implants, including Stryker Corp., have made it a practice to pay physicians that use their products five-, six- and even seven-figure royalty payments, consulting fees and speaking fees. Critics of such fees say they represent a conflict of interest, and sway doctors' judgments on how best to treat their patients. In the past year or so, the practice has attracted a great deal scrutiny, and now lawmakers, regulators and even the companies themselves are advocating that such payment arrangements be made public.

Many payments are legitimate. Doctors do in fact, speak at industry-sponsored conferences, and are very often instrumental in designing new joint implants. But because there was very little transparency in the way payments were made, it was difficult to discern when a payment was appropriate, and when it was just a kickback. It is that lack of transparency made it very easy for companies to engage in wrongdoing.

Even industry insiders have admitted that payments to physicians got out of hand. "With hindsight, it now appears that as industry expanded to meet patient needs, the use of consultants may have been excessive at times," Chad Phipps, general counsel for Zimmer Holdings Inc., said in testimony before Congress earlier this year.

The momentum for reform may have started last year when, according to the Philadelphia Inquirer, a U.S. attorney in New Jersey filed criminal complaints alleging that four of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by making payments to surgeons in an attempt to keep their business. Four of the companies, Biomet Inc., DePuy Orthopaedics, Smith & Nephew, and Zimmer Holdings Inc. - paid a total of $310 million, without admitting wrongdoing. A fifth manufacturer, Stryker Corp., cooperated with the probe and was not charged.

The settlements stipulated that the participants disclose any payments made to physicians on their websites. According to the Philadelphia Inquirer, those disclosures reveal that 51 doctors got more than $1 million each in 2007 alone. Several of those doctors were receiving royalties for implants they had a hand in designing.

Though those payments were disclosed as part of a settlement, it is becoming more common for such payments to be publicized. At the University of Pennsylvania Health System patients are told which implant companies are paying the doctors, though not the amounts, officials told the Inquirer. Many other hospitals have instituted similar policies.

Several members of Congress are pushing a bill that would require better disclosure. The Physician Payments Sunshine Act, for example, would require companies to disclose all gifts, fees or other compensation of more than $500 a year. If it passes, the Food & Drug Administration would create a searchable database of industry payments to all doctors. Trade groups for both the pharmaceutical and device industries have backed the measure.

At least one implant maker, Zimmer, is going even further. According to the Philadelphia Inquirer, earlier this year, the company announced that it would overhaul its compensation arrangements with doctors, ban gifts, and tighten its training programs. Zimmer has also banned its sales and marketing staff from playing a role in determining payments to physicians. Zimmer has also stopped paying doctors to speak at medical seminars.

CellCept Label Changed to Reflect Risk of PML

Mon, 30 Jun 2008 00:00:00 -0700

The maker of CellCept, Swiss Drug Maker Roche, has informed healthcare providers that it has modified the "Warnings" and "Adverse Reactions" sections of the CellCept prescribing information to include information on its association with several cases of Progressive Multifocal Leukoencephalopathy (PML).

CellCept—generically known as mycophenolate mofetil—is part of a class of drugs called immunosuppressants and was approved in 1995 to prevent rejection of solid organ transplants, including kidney, heart, and liver. When CellCept is used with cyclosporine and corticosteroids, it greatly reduces the patient’s immune system from attacking the transplanted organ. As with all immunosuppressants, CellCept carries certain risks, including development of lymphoma and other malignancies and is also linked to an increased risk of developing opportunistic infections and sepsis.

PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. According to the FDA, patients who survive the disease are often permanently disabled. In April, the Food & Drug Administration (FDA) announced that it was reviewing the safety of CellCept due to a possible association with PML. At the time, Roche said that it had confirmed 10 cases of PML in CellCept users.

PML is associated with at least one other drug, Tysabri, which is used to treat multiple sclerosis. Tysabri was actually removed from the market for a short time in 2005 because several patients taking it had died of the disorder. In 2005, the law firm of Parker Waichman Alonso LLP filed suit against Elan Inc. and Biogen Idec, the makers of Tysabri, on behalf of a woman who died from progressive multi-focal leukoencephalopathy while taking that drug. When contacted, Jerry Parker, the managing partner of Parker Waichman said that Tysabri case had been resolved, but that the resolution remained confidential.

Last October, CellCept was linked to miscarriage and birth defects, prompting the FDA to add a new boxed warning to its label last November. That labeling remains under FDA review. The potential for side effects was considered so great that the FDA advised women of childbearing age to use two methods of birth control before, during, and after CellCept treatment. The FDA reposted that warning in May.

Medical Device Safety Act Would Restore Consumer Rights

Fri, 27 Jun 2008 00:00:00 -0700

A bill to overturn a Supreme Court ruling that protects the makers of defective medical devices from product liability lawsuits was introduced in the House of Representatives yesterday. One of the bills sponsors, Rep. Frank Pallone, D-N.J, said in a statement that the Medical Device Safety Act of 2008 would reverse "an unfortunate Supreme Court decision that denied victims any legal recourse."

Sens. Edward Kennedy (D-Mass) and Patrick Leahy (D-Vt) plan to introduce companion legislation in the Senate.

Drug makers and medical device manufacturers have been waging an aggressive campaign in the courts to obtain protection against product liability suits. In February, medical device makers got their wish when the Supreme Court agreed with Medtronic Inc. and ruled that that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts.

That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Eight members of the Supreme Court agreed with Medtronic. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

The Bush Administration recently sided with drugmakers in another preemption case involving a Wyeth drug that is going before the High Court in the fall. It is expected that the Court will extend the preemption theory to pharmaceutical companies after it hears that case.

BPA in Medical Devices Concerns Lawmaker

Thu, 26 Jun 2008 00:00:00 -0700

Representative Rosa DeLauro (Democrat-Conneticut) is urging the US Food and Drug Administration’s (FDA) Science Board follow Health Canada’s lead and expand its inquiry of bisphenol A (BPA) by identifying all medical devices containing BPA. “Scientific studies have linked BPA to neurological and behavioral problems in youngsters, as well as certain cancers, diabetes, and obesity,” DeLauro wrote to Frank Torti, the FDA’s principal deputy commissioner and chief scientist.

The FDA has long maintained—even in the face of tremendous opposition—BPA’s safety. But earlier this month it asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA. The subcommittee will hold a public meeting on BPA’s safety in plastics, review an agency task force report on BPA, and present its findings at the Science Board’s annual meeting this fall, the FDA has said.

DeLauro says a review of bottles and food containers is not enough. “The potential risks posed to patients by BPA leaching from medical devices, especially implantable ones, would be very significant,” her letter says. “I strongly urge you to expand your request, and have the Science Board also assess the safety of BPA in medical devices.”

BPA is a ubiquitous chemical that has been under debate and in the news in recent months. BPA is a chemical compound that mimics estrogen and is found in polycarbonate plastics and epoxy resin. Studies confirm BPA is chemically similar to diethylstilbestrol, a synthetic estrogen linked to the development of vaginal cancer in the daughters of women who took the drug in the 1950s-1960s to prevent miscarriage. BPA has been in commercial use since the 1950s and is found in a wide variety of everyday items including water bottles, food and drink packaging, food can linings, dental sealants, CDs and DVDs, eyeglasses, and automobiles.

While the FDA now says it has been reviewing emerging literature on BPA on a continuous basis for years and its Center for Food Safety and Applied Nutrition initiated a formal reexamination of the safety of BPA in early 2007, as recently as last month, the FDA agreed with the chemical industry in defending its safety, announcing it saw no reason to advise consumers to stop using products made with the controversial chemical. In testimony before a Senate subcommittee, Norris Alderson, the FDA's associate commissioner for science, defended the FDA's reliance on two industry-funded studies in making this determination. Critics have accused the FDA of failing to act on BPA concerns and have accused them of acquiescing to industry.

This April, the National Toxicology Program (NTP) of the National Institutes of Health published a Draft Brief stating that some studies suggest BPA may raise “some concerns” for “neural and behavioral effects in fetuses, infants, and children at current human exposures” and also had "some concern" for exposure in these populations “based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females.”

Medical Devices Malfunction Due to Wireless Tracking Systems

Wed, 25 Jun 2008 00:00:00 -0700

The wireless systems which are used by many hospitals to track equipment may be creating potentially deadly breakdowns in lifesaving medical devices such as respirators, dialysis machines, and external pacemakers. Apparently, some microchip-based "smart" systems, hyped for their improvements to patient safety, are doing just the opposite. A Dutch study—123 tests at an Amsterdam hospital intensive care unit, without involving patients—reveals the systems could actually cause harm by sending out radio waves that can interfere with the equipment and warns hospitals to conduct safety tests on such systems. A U.S. patient-safety expert said the study "is of urgent significance" and that hospitals should respond immediately to the "disturbing" results.

During testing, electromagnetic “glitches” occurred in nearly 30 percent of the tests when microchip devices similar to those in many types of wireless medical equipment were placed within about one foot of the lifesaving machines. About 20 percent of the cases involved hazardous malfunctions that would likely harm patients, including respirators shutting off, mechanical syringe pumps ceasing to deliver medication, and external pacemakers malfunctioning.

Wireless systems monitor and track medical equipment like heart-testing machines, joint replacements, and surgical staplers, easily locating such devices throughout hospitals, aiding in theft prevention, and monitoring devices during surgery to prevent surgical errors. The systems also help in drug counterfeiting prevention by embedding microchips in drug containers.

The study confirms that hospitals must test their wireless items before using them near life-saving patient equipment, said Dr. Erik Jan van Lieshout, a study co-author and critical care specialist at the University of Amsterdam's Academic Medical Center. His study appears in Wednesday's Journal of the American Medical Association. "Attention must be paid to these disturbing findings," Dr. Donald Berwick, president of the Institute for Healthcare Improvement, said in an editorial in the Journal. "It seems that hospitals, regulators, and manufacturers certainly have some immediate work to do," including examining whether similar problems are occurring in hospital critical care units, Berwick said.

Meanwhile, earlier studies revealed that pacemakers and implanted heart defibrillators are susceptible to interference from cell phones and metal detectors outside hospital settings, according to FDA. This Dutch study was only focused on devices and equipment used in hospitals. "It is absolutely an issue, but you have to manage around it," said Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston, which uses the wireless technology for identification and tracking, including microchips embedded in intravenous pumps and ventilators. Halamka said the devices and the hospital's wireless system are compatible and all new machines are evaluated before being used near other electronic medical devices.

The JAMA piece suggests hospitals should consider surveillance for interference problems that employees haven't noticed or reported and that regulatory agencies should determine if new safety guidance is needed. Peper Long, a spokeswoman for the Food and Drug Administration (FDA), said the FDA is testing some medical devices to "determine their vulnerability and to what extent such vulnerability may be a public health concern."

New York Health Department Stops Using OraQuick Rapid HIV Test Following Hundreds of False Positives

Mon, 23 Jun 2008 00:00:00 -0700

The OraQuick Advance Rapid HIV-1/2 Antibody Test has been discontinued in New York City as a means of HIV testing there. The faulty test has been delivering unusually high false positive results and the US Centers for Disease Control and Prevention (CDC) have now become involved. In January 2004, New York clinics introduced and began offering on-site, rapid HIV testing of finger-stick, whole-blood specimens using the OraQuick test. The following March, the clinics replaced the finger-stick test with an oral fluid test, the OraQuick Advance Rapid HIV-1/2 Antibody Test.

The New York City Department of Health and Mental Hygiene, which operates 10 sexually transmitted disease walk-in clinics, stopped the popular OraQuick Advance Rapid HIV-1/2 Antibody Test over problems with false-positive results. Beginning in late 2005, the City’s clinics began noticing an unexpected increase in false-positive oral HIV test results. According to an online June 18 article in Morbidity and Mortality Weekly Report, published by the CDC, the increase subsided after several months. Use of the OraQuick Advance Rapid HIV-1/2 Antibody Test was suspended for three weeks in December 2005 and replaced with the finger-stick test while New York City health officials investigated the increase in false-positive test results. The finger-stick tests did not produce any false-positive results. And, while the OraQuick Advance Rapid HIV-1/2 Antibody Test was re-introduced in late December 2005, all positive test results were followed up with a finger-stick test.

Another false-positive spike in OraQuick Advance Rapid HIV-1/2 Antibody Test results occurred late last year; however, its cause has not been determined and the City health department has stopped the use of the oral fluid test. Only the finger-stick test is being used. "These findings underscore the importance of confirming all reactive HIV tests, both from oral fluid and whole-blood specimens," the report authors wrote. "In addition, the results suggest that the NYC DOHMH strategy of following up reactive oral fluid test results with an immediate finger-stick whole-blood test reduced the number of apparent false-positive oral fluid test results and might be a useful strategy in other settings and locations," they added.

In October 2004, OraSure Technologies, Inc. launched its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test as “the first and only U.S. Food and Drug Administration (FDA) approved and CLIA (Clinical Laboratory Improvements Amendments Act of 1988)-waived rapid point-of-care test that provides accurate results for both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.” A CLIA waiver allows such testing to be used by more than 180,000 sites in the US, including outreach clinics, community-based organizations, and physicians' offices.

OraSure develops, manufactures, and markets oral fluid specimen collection devices using proprietary oral fluid technologies; diagnostic products, including immunoassays and other in vitro diagnostic tests; and other medical devices. OraSure products are sold in the US and internationally to clinical laboratories, hospitals; clinics; community-based organizations; and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.

Icy Hot Heat Therapy Patch Recall Elicits FDA Warning Letter

Wed, 18 Jun 2008 00:00:00 -0700

The maker of Icy Hot Heat Therapy patches has been issued a warning letter from the Food & Drug Administration (FDA) for failing to notify the agency of labeling cautions added to the product after the company received more than 168 injury complaints. Chattem, Inc. recalled Icy Hot Heat Therapy products earlier this year after some consumers suffered burns after using the products.

The FDA warning letter stemmed from an inspection of the company's Chattanooga, Tennessee plant conducted from Feb. 5 through Feb 8. The Icy Hot Heat Therapy products were recalled on Feb. 8. The FDA said Chattem has 15 days to notify the agency about steps it was taking to correct problems cited in the warning letter.

Icy Hot Heat Therapy products are air-activated self-heating disposable devices designed to relieve muscle and joint pain. Chattem recalled the products after it had received some consumer reports of first, second and third degree burns as well as skin irritation related to their use. Involved in the Icy Hot recall were:

Icy Hot Heat Therapy Air Activated Heat- Back
Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heat- Arm, Neck, and Leg single consumer use “samples” included on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Crème.

Chattem said that in September it had added more information on the product’s label about how to use them, and it expanded the warnings to help prevent consumers from misusing Icy Hot Heat Therapy. However, according to the FDA warning letter dated June 6, Chattem did not inform the agency of those label changes in a timely manner. The company also did not report some complaints to the agency within the time period required by law.

The FDA warning letter also faulted the Icy Hot Heat Therapy products' label for a number of inadequacies. For example, the FDA said the label did not properly explain its warnings or caution that certain users such as children should not use the patches. The label also said the patches could be used for "up to 8 hours", which the FDA said "raises significant clinical concerns as this duration exceeds the established time at which a 2nd degree burn has been shown to occur on human skin at the target temperature of the patch."

Dangerous Medical Trash Left In Patients

Tue, 17 Jun 2008 00:00:00 -0700

Since 2003, the US Food and Drug Administration (FDA) received reports of 72 deaths and 4,675 injuries linked to “unretrieved device fragments,” or UDFs. Medical devices that break or malfunction is a growing and under-recognized phenomenon and earlier this year, the Federal Food and Drug Administration officials warned clinicians about the danger of such devices left in patients’ bodies such as broken stents, torn balloons, fractured wires, and stray parts ranging from catheter tips to drill bits.

“Patients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction, and death,” according to a Journal of the American Medical Association summary. Exacerbating the issue, some health workers never advise patients about the broken devices, leaving them with pieces that can either move through the body or dangerously interact with future procedures such as magnetic resonance imaging (MRI) where metal can overheat and scorch patients from within. Robert A. Fischer, an FDA nurse consultant who reviews adverse events, said he issued the public health notification after two years of “informal reports” indicating similar problems involving over 200 medical devices. “We decided that the best way to approach this was to say: ‘This is a problem and be careful,’” Fischer said.

The biggest problem is not just that devices break or doctors opt to leave them in the patient, but that doctors often don't tell their patients over concerns about worrying their patients or fear of legal consequences. The FDA reports likely underestimate the magnitude of the problem, said Dr. Mark Estes, president of the Heart Rhythm Society, a research and advocacy agency that has pushed for better enforcement of cardiac device standards. “The monitoring system is a passive system,” Estes said. “The FDA accepts what comes in from doctors and manufacturers. There is tremendous under-reporting of devices.”

The problems often stem from catheter wire guides breaking or fracturing or orthopedic bone screws. According to Dr. John R. Clarke, medical director of the ECRI Institute, a patient safety and research agency in Pennsylvania, UDF incidents are probably occurring with the same frequency as medical mistakes such as when sponges and instruments are left behind in surgery. In these cases, objects are inadvertently left behind in about 1 in every 1,000-1,500 abdominal operations, according to 2003 estimates. The issue with UDFs differs because doctors usually know the UDF is in the patient’s body but either does not, or is unable to, retrieve the UDF. “In some cases, finding a 10/0 [gauge] needle would be like looking for a contact lens in a shag rug carpet,” Clarke said. “Or, you know exactly where it is, but medically retrieving it would not be worth the risk. You’re not going to dig apart the femur to get a quarter-inch screw.”

Devices can break for a many reasons such as manufacturing defects; operator error; improperly stored catheters that have been exposed to light and have become brittle and fracture; or doctors having to use unfamiliar devices or tools when vendors switch styles without notice.

Medtronic Sprint Fidelis Lead Victim Asks Lawmakers to Restore Consumers Rights

Thu, 12 Jun 2008 00:00:00 -0700

A Pennsylvania woman went to Capitol Hill yesterday to ask lawmakers to overturn a Supreme Court ruling that has stripped consumers of their right to sue for injuries caused by defective medical devices. Bridget Robb was shocked more than two dozen times due to a defective Sprint Fidelis Lead attached to a Medtronic implantable defibrillator. Because the Supreme Court has taken away her right to sue the company, Robb said she was forced to go to Congress for justice.

Drug makers and medical device manufacturers have been waging an aggressive campaign in the courts to obtain protection against product liability suits. In February, medical device makers got their wish when the Supreme Court ruled that that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. Medtronic, which had brought the case before the Supreme Court, and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

The Bush Administration recently sided with drugmakers in another preemption case involving a Wyeth drug that is going before the High Court in the fall. There is little reason to suspect that the court will act differently towards pharmaceutical companies.

The only way consumers will preserve their rights to sue over defective drugs and medical devices is if Congress passes a law restoring those rights. Yesterday, several victims of faulty devices appeared on before a Congressional committee yesterday, asking lawmakers to do just that.

One of them was 34-year-old Bridget Robb. Robb told lawmakers that she was shocked 31 times in 13 minutes by a recalled Medtronic Sprint Fidelis defibrillator lead. The Sprint Fidelis lead was recalled by Medtronic last year after it received reports of 5 fatalities linked to lead fractures.

According to Robb, her six-year-old daughter watched in horror as her mother's defibrillator shocked her heart multiple times. Robb said she did not know about the Medtronic Sprint Fidelis recall until she arrived at the Emergency Room, even though the company claims it sent certified letters to all patients who received the devices.

Despite her pain and suffering, Robb and thousands of others injured by defective medical devices cannot get compensation for injuries because of the Supreme Court ruling. Hopefully, lawmakers will be moved by these stories and take action to restore the legal rights of all consumers.

Man Killed by Kugel Mesh Hernia Patch, Family Wants to Warn Others

Tue, 10 Jun 2008 00:00:00 -0700

Aaron Menendez endured two years following implantation of a Bard Composix Kugel mesh hernia patch before he suffered a serious infection and died this past September. Soon after his implantation, the patch was recalled. Menendez’s autopsy results confirm that the Bard Composix Kugel mesh was the cause of death. Now, Menendez’s family want others to know about this potentially fatal medical device.

Over 700,000 hernia repair surgeries are performed in the U.S. annually. Hernias are areas where an organ breaks through weakened or torn tissue. Before the Davol Composix Kugel Mesh Hernia Patch, repair was conducted by tension repair surgery, which could cause problems if muscle tissue re-tore. The patch—developed to reduce re-tears—is constructed of two mesh pieces surrounding a plastic ring. The surgeon makes a tension-free repair using a small incision and places the folded patch behind the hernia. The spring-like ring opens the patch where it lays flat behind the incision allowing internal tissue to grow and repair the tear or weakness, resolving the hernia.

Bard, Davol’s parent company, knew about severe injuries caused by the device although they claim they acted responsibly and didn’t take the product off the market because the number of complaints were small given the number of patches sold and problems cited were too random. In all, patches were recalled three times by the US Food and Drug Administration (FDA) who received nearly 100 reports of problems related to the patch, several involving death. Davol, received reports of up to 10 complications from the patches, with one possible fatality, yet Davol delayed reporting a massive recall for months because initial complaints all came from Germany, with three from one doctor. Davol concluded ring breaks were due to physician error, halted production of some patches, trained German doctors, revised physician instructions, and continued distributing other patches. Davol was wrong; problems continued.

The problem was not with a doctor but is in the Bard Composix Kugel mesh hernia patch ring. Tests run on a failed patch indicated a ring weld defect, meaning that the ring can break, exposing shards that have caused bowel perforations and obstructions, serious infections, and chronic fistulae (abnormal connections between intestines and organs). Despite this and despite Class I recalls (indicating a serious danger), Davol recommended that products continuing to function properly should not be replaced as there could be greater risk in removing a properly functioning device. Requesting replacement surgery is not an option.

The FDA ordered Davol to investigate and correct procedures and accused Davol of knowingly keeping defective patches on the market and understating their severe and dangerous complications. An inspection at Davol unearthed other problems: Serious flaws in their complaint tracking system (systems incompatibility); shoddy procedures (an inability to handle everything from complaint investigation to recall actions determination); and an absence of testing documentation on the manufacture of Salute Reusable Fixation devices (for attaching mesh in laparoscopic and open hernia repair and pelvic floor reconstruction). The FDA said Davol’s procedures were to blame for delays in dealing with the problems; that Davol did not accurately report complaint severity; and problems found during inspection could be symptomatic of serious underlying issues in their quality assurance system.

Kugel Mesh Hernia Patch Used At Virginia Hospitals Long After Recall

Mon, 09 Jun 2008 00:00:00 -0700

The defective Kugel Mesh Hernia Patch - recalled several years ago - was mistakenly implanted in seven patients at two Virginia hospitals. At least one woman who received a recalled Kugel Mesh Hernia Patch at one of the two hospitals owned by Sentara Health Systems says she has been living in excruciating pain since her surgery, and is worried that the medical device might be putting her life in danger.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quit using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice - in 2006 and 2007 - to include several other sizes of the device.

Apparently, not all hospitals have gotten the word on the Kugel Mesh Hernia Patch recall - at least not in the case of Sentara Virginia Beach General Hospital and Sentara Leigh Hospital. Officials from the Virginia health system admitted last week that four patients at the Virginia Beach location, and three others at Leigh were implanted with the dangerous hernia patch.

Sentara was first alerted to the problem when Virginia Beach's Judith Coyne, who had hernia surgery last June - six months after the final Kugel Mesh Hernia Patch recall was announced - related her story to a Virginia TV station. Coyne said shortly after her surgery, she began having excruciating abdominal pain. When she and her son got her medical records, using the product code and lot number, they determined that the Kugel Mesh Hernia Patch which was implanted in her during surgery was recalled. According to WAVY.com, Coyne says doctors now tell her that the mesh is stuck to her organs and aren't willing to operate because it could kill her. But Coyne lives in fear that the Kugel Mesh Hernia Patch inside her body will put her life in danger if it should break.

At first, Sentara insisted that Coyne's Kugel Mesh Patch was not the same lot number as the one recalled, but later released a statement conceding that the patch was, in fact, subject to recall. The statement said that Sentara had "contacted Ms. Coyne's surgeon and requested that he conduct a follow up examination and evaluation so that we can provide any assistance possible to address her pain issues."

Late last week, Sentara announced that Coyne was not the only patient implanted with a recalled Kugel patch. Sentara's Vice President Of Medical Affairs, Dr. Tom Thames told Fox 43 that the recalled patches were implanted in 7 people at the hospitals "as a result of human error." While Davol did inform Sentara of the Kugel Mesh Hernia Patch recall, Dr. Thames said that because the recall occurred in stages, it was confusing.

Sentara is in the process of notifying all of the patients who received the recalled Kugel Mesh Hernia Patch, and says it will offer assistance to those patients. Anyone with questions can call the health system at 1-800-SENTARA, weeknights until 11:30 p.m.

Tainted Heparin Used in Medical Devices Linked to 11 Deaths

Fri, 06 Jun 2008 00:00:00 -0700

Tainted Heparin made by Baxter International has been linked to more than 80 deaths and hundreds of adverse reactions in the US, resulting in a massive recall of Baxter Heparin earlier this year. Internationally, several other heparin makers have issued their own recalls of tainted heparin, and dozens of similar reactions - though no deaths - were reported in Germany. Eventually, it was discovered that the main ingredient in some Heparin, which is made in China and derived from pig intestines, turned out to be contaminated. Now, it appears that additional fatalities may have been caused by medical devices made with tainted Heparin.

At least 11 deaths and 86 cases of harmful side effects reported this year in the US have been linked to the use of medical devices containing the blood thinner Heparin. Most of the cases involved Heparin used to clean intravenous lines, said Karen Riley, a Food and Drug Administration (FDA) spokeswoman. According to Riley, the Heparin associated with two of the 11 deaths wasn't contaminated and the FDA is unable to conclusively say how most of the other deaths and side effects involved the tainted Heparin. Riley also said that she was unable to identify which companies' products were associated with the adverse reactions and deaths.

Heparin is a blood thinner administered in surgery and other critical care areas to prevent clots, is crucial in dialysis and heart surgery, and is used for the bedridden. Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and Baxter manufactures about half of all multiple-dose heparin vials sold in the US. The FDA has reported that, since the end of 2007, it received over 700 reports of adverse reactions associated with Baxter's multiple-dose injectable Heparin; 40 percent of these reports were deemed serious. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in 21 cases, led to death.

The ensuing investigation revealed problems regarding inadequate FDA inspections of overseas drug and drug component manufacturers and ingredients obtained from shoddy, unregulated factories. These inadequacies served to highlight some of the critical problems going on at the FDA and have led to government investigations and hearings over FDA practices.

In addition to Baxter, companies including the device make Medtronic Inc. have voluntarily recalled products that may contain contaminated Heparin. Side effects and deaths linked to medical devices occurred between January 1 and May 14, according to the FDA's Website. Since January 2007, 81 people have died after allergic reactions, the FDA said on April 21. Riley said the 11 deaths involving devices are “probably in addition'' to the 81, though some of the reports to the FDA are “very sketchy'' and there could be “some minor overlap.''

The FDA also said contamination could lead to inaccurate test results from diagnostic devices that monitor Heparin or use it as part of the device itself.

Baxter has said the main ingredient for its heparin probably was contaminated before reaching its supplier in China.

The European Medicines Agency said today in a statement that one of its committees concluded a type of Heparin, enoxaparin, can still be used, provided that measures are taken to reduce risks. Enoxaparin was found to include a low level of contamination. Sanofi-Aventis SA's Lovenox contains enoxaparin.

Asthma Patients Will Need New Inhalers Soon

Mon, 02 Jun 2008 00:00:00 -0700

Patients who use albuterol inhalers to control asthma take note - the inhaler you are accustomed to will no longer be available at the end of this year. Last week, the Food & Drug Administration (FDA) warned patients not to wait until the last minute to switch to newer alternatives.

The old-style albuterol inhalers used chemicals called chlorofluorocarbons, or CFCs, to propel the drug into the lungs. But CFC-containing consumer products are being phased out because the chemicals damage the Earth's protective ozone layer. The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under the treaty, the US agreed to phase out production and importation of ozone depleting substances including CFCs.

As of Dec. 31, asthma inhalers with CFCs can no longer be made or sold in the US. Inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes. Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

The FDA said that manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now. According to the agency, HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.

Pacemakers Vulnerable to Hackers, Researchers Say

Thu, 29 May 2008 00:00:00 -0700

Pacemakers can be hacked - relatively easily. Now a research team that was able to hack the implantable defibrillators that keep sick hearts beating steadily are telling federal regulators that the problem needs to be addressed.

In recent years, over 100,000 patients in the US have been implanted with a defibrillator device - or pacemaker - that has helped to reduce medical visits. The device and its technology enable patient information to be sent to a bedside monitor that then sends the data to a doctor. Transmissions generally occur once daily. But researchers at the University of Massachusetts Amherst and the University of Washington have discovered that the defibrillator monitoring technology is vulnerable to hacking and—worse—reprogramming that could stop the defibrillators from providing a lifesaving shock.

The Medical Device Security Center, a collaboration of researchers from three universities, tinkered with one on a lab table, after buying $30,000 worth of commercially available equipment to assist the hacking. Researchers ran tests that deduced how a particular defibrillator worked. They used that information to alter it from less than an inch away. Potentially, they said, an attacker could disrupt heartbeats, dangerously drain a battery or even extract private medical information. Their findings were presented May 19 in Oakland, Calif., at a symposium on security and privacy being put on by IEEE, a technology association.

There have been no reports of pacemakers being hacked. But Dr. William Maisel, a Harvard cardiologist who worked with the Center, says the time to take action is now. "This is not an important risk for patients right now," said Dr. Maisel said, "We just want the industry to be thoughtful about where we as a society are going with these devices."

Last month the group discussed its findings with the Food & Drug Administration and a trade association for implanted devices.

Reports of Squeaky Hip Implants Growing

Tue, 27 May 2008 00:00:00 -0700

More patients are complaining of squeaky hip replacement implants. As recently as 2006, the American Association of Orthopedic Surgeons called the recently emerging hip squeaking phenomenon an “underreported medical trend that has stumped the medical community.” “As a surgeon, hearing someone walk, hearing them squeak, it’s a little unsettling,” said Dr. Andy Star, chief of orthopedics at Abington Memorial Hospital. “We are a little anxious about it and we honestly don’t know what to tell the patients.”

Other than going through a second major surgery, there are virtually no options for dealing with the squeaking that doctors are reporting among some patients who received ceramic hip replacements. Reports of noisy joints following hip replacements were very rare before 2003 when the federal Food and Drug Administration (FDA) approved the first ceramic-on-ceramic implant for total hip replacements.

According to the American Academy of Orthopaedic Surgeons, about 235,000 total hip replacements were performed in 2005. The surgery involves substituting deteriorated hip joints with plastic, metal, and ceramic materials that can either be used together or in different combinations. Ceramic has been used in joint replacement surgery since the 1970s; modern medical grade ceramic is harder and scratch-resistant and lab tests indicate it produces less wear and tear and lasts longer. Durability tends to be why total ceramic hips are popular among younger, more active patients. Currently, no medical evidence links the noise to structural problems with the parts and patients complaining of noise report no pain or other physical problems with the implants.

Noise complaints are almost exclusively reported by patients with both ceramic ball and socket combinations and a 2006 study in the Journal of Arthroplasty found 10 out of 143 patients—seven percent—who underwent total ceramic hip replacement from 2003 to 2005 developed squeaking when walking, bending, and even during sexual activity. Another 31 patients reported their new hips made other noises, such as popping and grinding. No squeaks were reported among 48 patients who received hips made of metal and plastic. And, some doctors say they’ve heard of no noise reports from patients with ceramic and plastic or metal combination implants.

Stryker Orthopaedics-manufactured Trident implants account for the majority of complaints and the FDA issued a warning to Stryker last year for manufacturing and quality problems with its ceramic hips, including squeaking. Stryker maintains its product is safe and the FDA warning and a subsequent recall involving ceramic hip parts made at an Ireland plant were not related to squeaking, which it says occurs with less than one percent of its ceramic implants.

No one seems to be able to pinpoint the source of the squeaking; however, some believe decreased lubrication in the joint, mismatch of implant parts, and extreme flexing of the implants may be to blame. Doctors who’ve removed the ceramic implants report evidence of accelerated wear, but durability tests do not indicate pending joint failure.

One study suggests that squeaking occurring when patients bend forward could be managed with different bending techniques. For those who experience squeaking from walking, it seems a second surgery is the only option.

Replacement Hormone Therapy Can Double Clot Risk

Fri, 23 May 2008 00:00:00 -0700

A French review of a variety of studies just revealed that menopausal women who take hormone-replacement therapy (HRT) pills more than double their risk of developing a potentially fatal blood clot. The review of 17 studies suggested that the risk was also significantly higher during the first year of HRT. The findings appear in the British Medical Journal.

HRT relieves serious menopausal symptoms such as hot flashes and was popular until a 2002 study—The Women’s Health Initiative—suggested it could raise the risk of breast and ovarian cancer, strokes, and other life-threatening conditions. Arterial blood clots are a common cause of heart attacks and strokes; vein blood clots can kill if they move to the lungs. "This meta-analysis ... showed that current use of oral oestrogen increases the risk of (blood clots) by two-fold to three-fold," Pierre-Yves Scarabin and Marianne Canonico of the Paul Brousse Hospital in France wrote. Earlier trials linked HRT drugs to blood clots; however, the French review marks the first systematic meta-analysis—a review of what myriad studies found—to truly assess the risk.

Analysis of eight observational studies and nine randomized controlled trials found that HRT via patch showed no significant increased risk, unlike the pills. Perhaps due to the different way oestrogen—oral estrogen—is absorbed. Further research is needed to confirm the findings, the team said. When taken orally, oestrogen enters through the digestive system and is processed by the liver, which might impair the balance between clotting and anti-clotting factors in the blood, the researchers said.

Meanwhile, in January, U.S. researchers reported HRT significantly raises the risk of an uncommon type of breast cancer. The study found women who took combined estrogen/progestin HRT for three years or more had four times the usual risk of lobular breast cancer. The study, published in the January issue of Cancer Epidemiology, Biomarkers and Prevention, is one of dozens of studies looking to clarify the dangers of taking HRT to treat menopause symptoms. "Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," Dr. Christopher Li of the Fred Hutchinson Cancer Research Center, who led the study, said. "Our study, the first specifically designed to evaluate the relationship between combined HRT and lobular breast cancers, suggests that a significantly shorter length of exposure to such hormones may confer an increased risk," he added. According to the American Cancer Society, lobular breast cancer accounts for about 10 percent of all invasive breast cancers, the cancers that most threaten to spread to other parts of the body.

Historically, doctors believed HRT could protect women from chronic diseases, especially heart disease. But use of HRT plunged after the 2002 Women's Health Initiative study confirmed HRT could raise the risk of certain cancers, strokes, and other serious conditions. Research since also indicates that the incidence of breast cancer dropped by 8.6 percent between 2001 and 2004 in the U.S., in conjunction with the decline in HRT use.