Acellular Dermal Matrix Lawsuits

WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) released an important FDA Safety Communication concerning Acellular Dermal Matrix (ADM) products used in implant-based breast reconstruction surgery that appear to have a higher probability for issues or complications. The FDA is warning surgeons, health care providers, and patients of its recent analysis concerning Acellular Dermal Matrix (ADM) products and is requesting immediate reporting of all adverse events to help the agency better understand the risks of ADM products.

Women who are undergoing reconstructive breast surgery after a mastectomy are typically given several surgical options. In breast reconstruction procedures using implants, the surgeon may choose to use only breast implants or use breast implants with ADM. Acellular Dermal Matrix is a surgical mesh that is developed from human skin or animal skin. The use of ADM in breast reconstruction surgery has not been cleared or approved by the FDA.

Prior to surgery, patients undergoing breast reconstruction surgery should discuss the risks, benefits, and potential complications associated with implant-based breast reconstruction with or without ADM. If the surgeon is suggesting that ADM should be used, speaking with that surgeon  about the type of ADM to be used during the surgical procedure is essential.

Acellular Dermal Matrix (ADM) is a surgical mesh that is developed from human skin (FlexHD, AlloMax, AlloDerm) or animal skin (SurgiMend). The product is manufactured by removing cells and leaving the support structure in place. According to the FDA, ADM products vary significantly in their source material, biomechanical properties, processing, level of sterility, final product state, thickness, and preparation methods before surgical application.

The Mastectomy Reconstruction Outcomes Consortium (MROC) study collected data from 11 medical centers, including nine academic hospitals located in the United States and Canada, that performed a high volume of breast reconstruction procedures. The purpose of the study was to assess the outcomes in patients who underwent implant-based breast reconstruction after a mastectomy. The study collected data on major post-surgical complications, including reoperation, explanation (implant removal), and infections. The FDA conducted an analysis based on this data, comparing the complication rates between the control group, those patients who never received ADM, and groups receiving one of the suspect ADM brands (FlexHD, AlloMax, SurgiMend, and AlloDerm.)  The FDA also analyzed and compared the complication rates between the various ADMs themselves.

The FDA’s review of the MROC study’s data revealed substantially higher “major complication” rates of explanation, reoperation, and infections in the groups of patients implanted with 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 any ADM products. Moreover, the increase in complications connected with AlloMax or FlexHD was observed across multiple sites.

Physicians must be aware that real-world data suggests some ADM products could have higher risk profiles than others. Right now, the FDA is not recommending preventive reoperation and removal of any implanted ADM. The FDA also stated that it is not aware of any data that proves there is a link between ADM use and the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The root cause of the varying complication rates between the different brands of ADM is unknown. However, patients and health care providers are being put on notice of the  FDA’s findings and concerns.  They are being told to report adverse events to the FDA in hopes of better understand the risks associated with Allomax and FlexHD.