The U.S. Food and Drug Administration alerted patients and doctors last week that two brands of surgical mesh used in breast reconstruction surgery may present a higher risk of complications than similar brands.

Breast reconstruction surgeries are typically performed to rebuild the breast after mastectomy (breast removal) or lumpectomy (lump removal) during breast cancer treatment. Breast reconstructions can be performed with just breast implants or with the additional use of surgical mesh, which is used to reinforce weak tissues. Surgical mesh is made from biological tissues, from synthetic materials such as polypropylene, or a combination.

FDA Research Findings

The two mesh brands of concern, FlexHD and Allomax, are a type of biological mesh known as acellular dermal matrix. FlexHD and Allomax are both derived from human skin, although ADMs can also be derived from animal skin. In either case, the skin cells are removed and the collagen protein matrix from the connective tissue is left behind.

Although the FDA has cleared certain ADMs for use in other types of surgery, such as hernia surgery, the growing use of ADMs in implant-based breast reconstruction is what’s known as an “off label” use.

The FDA analyzed patient data from 11 hospitals in the U.S. and Canada with high volumes of breast reconstruction surgeries. Researchers found a “significantly higher” rate of complications in FlexHD and Allomax brands compared with two other brands of ADMs and in breast implant surgeries performed without ADM. The study tracked major complications such as infections and the need for removal surgeries up to two years after breast reconstruction. The higher complication rate was seen across multiple hospitals.

The FDA noted that four peer-reviewed studies published in medical journals also found safety differences among different ADM brands consistent with the agency’s research.

FDA Patient Safety Recommendations

Patients and health care providers are advised to discuss the risks and benefits of ADM prior to breast reconstruction surgery, as well as the type of ADM being considered. 

Patients and providers should be aware that the FDA has not cleared or approved any brands of AMD for breast reconstruction surgery.

The FDA encourages prompt reporting of any adverse reactions through the MedWatch Online Voluntary Reporting Form. Please be sure to include the brand name of the mesh, model number, manufacturer, and a detailed description of the problem.