FlexHD Lawsuits for Breast Implant Reconstruction Surgery Failures, Necrosis, Breast Implant Explantation, Seroma, and Other Major Complications
WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) announced an important FDA Safety Communication warning that FlexHD Acellular Hydrated Dermis (AHD) and certain Acellular Dermal Matrix (ADM) products that are used in 80% of implant-based breast reconstruction seem to have a larger chance of major post-operative complications. The FDA published a warning to doctors, health care providers, and patients concern about the agency’s recent analysis of FlexHD and Acellular Dermal Matrix products. The FDA is asking for patients and doctors to report any complications or adverse events to help better identify the risks associated with Acellular Dermal Matrix products. The issues appear to arise after about two years of implantation.
For women who are considering reconstructive breast surgery following a mastectomy involving implants, the surgeon may elect to use only breast implants or use breast implants with FlexHD or a brand of Acellular Dermal Matrix product. In about 80% of breast reconstructive or augmentation surgery, FlexHD or ADM meshes are used. However, the use of FlexHD in breast reconstruction surgery is off-label, as FlexHD Hydrated Dermis (AHD) or ADM products have not been cleared or approved by the FDA for breast augmentation breast reconstructive surgeries.
Which Acellular Dermal Matrix Mesh (ADM) Products Are Being Reviewed for Possible Compensation?
- Flex HD (FlexHD)
Did you or your loved one experience harm due to FlexHD? Parker Waichman LLP helps victims and families obtain full monetary compensation for harm caused by FlexHD, Hydrated Dermis (AHD) products, or 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 Loved One Suffer One or More of The Following Complications Caused by FlexHD (Ethicon/Johnson & Johnson)?
- Mastectomy flap/skin necrosis,
- Implant explantation (implant or additional breast tissue removal), and/or
- Reconstructive failure.
The FDA Published the Following Directives to Patients and Caregivers Concerning Breast Reconstruction
Patients who are electing breast reconstruction or augmentation surgery should discuss the risks, benefits, and possible complications connected with ADM products with their surgeon. If the surgeon recommends that ADM be used as an off-label option, patients must know that FlexHD and ADMs have not been cleared or approved by the FDA for use in any types of breast surgery. Also, patients should discuss with their physician which type of ADM will be used during their surgery.
ADMs are often used in other reconstructive surgeries such as hernia repairs. However, the FDA states that the off-label use of ADM products in breast augmentation or reconstruction procedures is not cleared or approved by its agency.
If you or a loved one had breast augmentation or reconstruction or surgery with FlexHD or an ADM and are encountering infections, necrosis, complications, Seroma, reconstructive breast failure, side effects, discomfort, cellulitis, or any other problem, the FDA is asking you or your doctor report these issues and medical conditions to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.
Doctors who perform breast reconstructive surgery should be informed that the FDA has not approved or cleared or the “off-label” use of FlexHD or ADM products in implant-based augmentation or reconstruction surgery. Moreover, brand-new data evaluated by the FDA and published literature states that FlexHD and certain ADMs have been linked to higher risk profiles than other ADM products.
The FDA does not recommend removing implanted FlexHD or ADM products or for patients to undergo a reoperation as a preventive measure at this time.
FlexHD® STRUCTURAL, Acellular Hydrated Dermis Product Description
FlexHD is a Hydrated Acellular Dermal is a surgical mesh that is manufactured from human skin (FlexHD, AlloMax, AlloDerm). The product is manufactured by removing cells while leaving the supportive tissue structure in place. While surgical products like FlexHD are cleared and approved by the FDA for some surgical procedures, such as hernia repair surgeries, there is little known about the possible complications of products such as FlexHD.
The FDA affirms that FlexHD and ADM products vary significantly in their level of sterility, source material, final product state, biomechanical properties, processing, level of sterility, thickness, and preparation methods prior to surgical application.
ADM Risk Profile in Implant-based Breast Reconstruction Surgeries
FlexHD and ADM have been used as off-label in implant-based breast reconstruction treatment. FlexHD and ADM products are now used in approximately 80% of breast reconstructive surgeries. Many doctors use FlexHD and ADM meshes in the chest area for augmentation or reconstructive surgery “off-label” since these products have been approved in other surgical procedures. Some manufacturers even market their AMD products for use in breast reconstruction operations. However, the FDA has made it clear that the agency did not approve or clear any ADM products for any breast reconstruction or augmentation procedures.
The FDA has completed its overall analysis of patient-level data obtained from ADM usage in implant-related breast reconstruction. The data affirmed that FlexHD, and Allomax, produce a “higher risk profile” than the other ADM products.
A Mastectomy Reconstruction Outcomes Consortium (MROC) study compiled data from eleven medical centers, including nine academic hospitals, that perform a high volume of breast reconstruction surgeries in the United States and Canada. The study’s intent was to assess the results in patients who underwent implant-based breast reconstruction surgery following a mastectomy. The study accumulated data on reported post-surgical complications, including explanation (implant removal), reoperation, necrosis, and infections. The FDA administered an analysis based on the data accumulated. It compared the complication rates between patients who never received ADM (the control group), and study groups that received one of the ADM brands: AlloDerm, FlexHD, AlloMax, SurgiMend.
The FDA’s investigation of the MROC study’s data exhibited considerably higher “major complication” and rates of explanation, necrosis, infections, and reoperation in the study groups of patients who received either FlexHD and AlloMax brands within two years of the surgery when compared to study groups of patients who received AlloDerm or SurgiMend ADM brands, or the control group that did not receive any ADM products. The increase in major complications related to AlloMax or FlexHD implantation was seen across multiple sites.
Many peer-reviewed papers in the medical literature suggest variations in the safety profiles amongst the different ADM brands. These variations involve Allomax (manufactured by Becton Dickinson/Bard) and FlexHD (manufactured by Ethicon/J&J), are consistent with the FDA’s findings.
Doctors should understand that real-world data shows that some ADM products such as Allomax (Becton Dickinson/Bard) and FlexHD (Ethicon/J&J) have higher risk profiles than other ADM mesh products. The FDA is not prescribing that patients undergo a preventive reoperation to remove the ADM. The FDA also stated that the agency is unaware of any data that establishes a link between ADM use and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The underlying cause of the differing complication rates between the different brands of ADM is unknown. However, surgeons and patients must be made aware of the FDA’s findings, and patients should report all adverse events to the FDA to help the agency better understand the risks associated with FlexHD and Allomax.
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Did you or a loved one suffer harm due to FlexHD? Parker Waichman LLP helps victims receive justice and recover full monetary compensation for harm caused by FlexHD. Trust your case with our defective product injury attorneys. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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