March 31, 2021
The following quote is attributed to Binita Ashar, M.D., director, Office of Surgical and Infection Control Devices, FDA’s Center for Devices and Radiological Health:
“The FDA has issued a safety communication today to inform the public and health care providers about the higher chance for complications or problems related to the use of certain acellular dermal matrix (ADM) products, a type of surgical mesh, in implant-based breast reconstruction.
Over the past several years, the use of ADM has increased and is now commonly used off-label in implant-based breast reconstruction. We strongly encourage patients to discuss all the possible benefits and risks related to breast reconstruction procedures with their surgeon, including the pros and cons of the use of different brands of ADM.
The FDA remains committed to protecting patients’ health and ensuring the safety of implant-based breast reconstruction. We will continue to monitor the latest scientific literature, as well as reports of adverse events related to ADM use to help us understand the risks and keep the public apprised of any important new data."
- Today, the U.S. Food and Drug Administration issued a safety communication to inform patients and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems. ADM, a type of surgical mesh, is developed from human or animal skin, in which the cells are removed and the support structure is left in place.
- The safety communication summarizes an analysis of data from a study evaluating outcomes in patients undergoing implant-based breast reconstruction after mastectomy. The analysis showed significantly higher complication rates of explantation (implant removal), reoperation and infection in patients with FlexHD and AlloMax brands of ADM two years following surgery, when compared with patients who received SurgiMend or AlloDerm brands, or no ADM.
- In addition, the FDA provides important recommendations for patients, caregivers and health care providers, including: discussing the risks and benefits of implant-based breast reconstruction with or without ADM use; being aware that the FDA has not cleared or approved ADM or mesh for use in breast reconstruction; and reporting any adverse events associated with the use of ADM.
- Over the past several years, there has been increasing use of ADM by surgeons, and it is now commonly used in implant-based reconstruction. An advisory committee meeting held by the FDA in March 2019 included a discussion by the panel of the use of ADM for breast reconstruction. The FDA does not recommend reoperation or removal of implanted ADM as a preventive measure.
- The FDA advises patients who have had breast reconstruction with ADM and have experienced problems to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.