Allomax Lawsuits for Breast Implant Reconstruction Surgery Failures, Breast Implant Explantation, Necrosis, Seroma, and Other Major Complications
WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) announced an important FDA Safety Communication warning that Allomax Acellular Dermal Matrix (ADM( products used in about 80% of implant-based breast reconstruction appear to have a greater chance of serious post-operative complications.
The FDA issued a warning to surgeons, health care providers, and patients of its recent analysis concerning Allomax Acellular Dermal Matrix and is asking for immediate reporting of any problems, complications, or any other adverse events to help better identify the risks associated with Acellular Dermal Matrix products.
Women who are about to have reconstructive breast surgery after a mastectomy are given several surgical options. In breast reconstruction or augmentation procedures that involve implants, the surgeon may choose to use only breast implants or use breast implants with ADM.
In about 80% of breast reconstructive or augmentation surgery, ADM is used. However, the use of ADM mesh used in breast reconstruction surgery is off-label, and Allomax has not yet been cleared or approved by the FDA for breast augmentation or breast reconstructive surgery.
Which Brands of Acellular Dermal Matrix Mesh (ADM) Are Being Reviewed for Possible Compensation?
- Allomax
- Flex HD
Did you or your loved one experience harm due to Allomax? Parker Waichman LLP helps victims and families receive justice and full monetary compensation for harm caused by defective Acellular Dermal Matrix (ADM) products. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
Did You or a Family Member Suffer One or More of The Following Complications Caused by Allomax (Becton Dickinson/Bard)?
- Infection,
- Seroma,
- Mastectomy flap/skin necrosis,
- Cellulitis,
- Implant explantation (implant or additional breast tissue removal), and/or
- Reconstructive failure.
The FDA Issued the Following Recommendations and Guidance for Breast Reconstruction Patients and CaregiversPatients who are about to undergo breast reconstruction surgery should discuss the risks, benefits, and possible complications connected with implant-based breast reconstruction using ADM. If the plastic surgeon is suggesting that ADM be used as an off-label alternative, which is not cleared or approved by the U.S. FDA, be sure to ask your physician about which type of ADM will be used during the surgical procedure.
ADM is used in several types of reconstructive surgical procedures. However, the FDA clarified that off-label use of ADM products for use in breast reconstruction or augmentation procedures has not been it has never approved or cleared by their agency.
If you or a family member had breast reconstruction or augmentation surgery with Allomax ADM and are experiencing complications, reconstructive breast failure, side effects, Seroma, cellulitis, infections, necrosis, discomfort, or any other problem, the FDA is urging you to report these issues and medical conditions to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
Health care professionals should be conscious that the FDA has not approved or cleared the use of ADM products in implant-based reconstruction or augmentation surgery. Moreover, recent data reviewed by the FDA and published literature states that Allomax ADM has been connected to higher risk profiles than other ADM products.
The FDA is not currently advising the extraction of implanted ADM or reoperation as a preventive measure at this time.
Allomax Acellular Dermal Matrix (ADM) Product Description
Allomax is an Acellular Dermal Matrix (ADM) surgical mesh that is manufactured from human skin (FlexHD, AlloMax, AlloDerm) or animal skin (SurgiMend). The product is produced by removing cells and leaving the supportive structure in place. While certain ADMs are cleared and approved by the FDA for some surgical procedures, such as in hernia surgery, there is little known about ADM’s possible complications.
The FDA states that ADM products vary significantly in their original material, processing, biomechanical properties, level of sterility, thickness, final product state, and preparation methods before surgical application.
ADM Risk Profile in Implant-based Breast Augmentation and Reconstruction Procedures
Over the past several years, ADM has been used as off-label in implant-based breast reconstruction treatment. The use of ADM in breast augmentation or reconstructive surgeries has become very common and is used in about 80% of procedures. Many doctors use Allomax mesh in the chest area for augmentation or reconstructive surgery “off-label” since ADM products have been approved in other surgical procedures. However, the FDA made it clear that the agency has not approved or cleared any ADM products for breast reconstruction or breast augmentation procedures.
The FDA has finished its overall review of patient-level data collected from ADM usage in implant-based breast reconstruction. The data affirmed that two ADMs, FlexHD, and Allomax, produce a higher risk profile than the other ADM products.
A Mastectomy Reconstruction Outcomes Consortium (MROC) study accumulated data from eleven medical centers, including nine academic hospitals that performed a high volume of breast augmentation and reconstruction surgeries in Canada and the United States. The study’s goal was to evaluate the outcomes in patients who underwent implant-based breast reconstruction surgery following a mastectomy. The study collected data on reported major post-surgical complications, including reoperation, explanation (implant removal), and infections. The FDA conducted an analysis based on the data compiled, and it compared the complication rates between patients who never received ADM (the control group), and groups that receiving one of the ADM brands: AlloDerm, FlexHD, AlloMax, SurgiMend.
The FDA’s review of the MROC study’s data showed considerably higher “major complication” and rates of explanation, infections, and reoperation in the groups of patients who received either FlexHD and AlloMax brands of ADM within two years of the surgery when compared to groups of patients who received AlloDerm or SurgiMend ADM brands, or the control group that did not receive ADM products. The increase in serious complications connected with AlloMax or FlexHD was seen across multiple sites.
The underlying cause of the varying complication rates between the various ADM brands of ADM is unknown. However, health care providers and patients need to be made aware of the FDA’s findings and should report adverse events to the FDA to help the agency better understand the risks associated with Allomax and FlexHD.
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