FDA Announces Some Acellular Dermal Matrices In Breast Reconstruction May Have Higher Chance for Complications
On March 31, 2021, the U.S. Food and Drug Administration (FDA) announced that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.
There are several methods for reconstructing the breast following mastectomy (surgical removal of the breast). For patients who will have breast reconstruction using implants, the surgeon may use a breast implant alone, or both a breast implant and ADM. The FDA has not cleared or approved ADM or mesh for use in breast reconstruction. Please note that the FDA announcement refers to the use of ADMS used in breast reconstruction rather than breast augmentation revision.
- Be aware that the FDA has not approved or cleared any ADM products for use in implant-based breast reconstruction. Data analyzed by the FDA and published literature suggest that some ADMs may have higher risk profiles than others.
- Be aware that the FDA does not recommend reoperation or removal of implanted ADM as a preventive measure.
Acellular Dermal Matrix (ADM), a type of surgical mesh, is developed from human skin (such as FlexHD, AlloMax, AlloDerm) or animal skin (such as SurgiMend), in which the cells are removed and the support structure is left in place. Some ADMs have been cleared by the FDA for use in certain types of surgeries, such as in hernia surgery, to reinforce tissue where weakness exists.
ADMs vary significantly in their source, processing, level of sterility, biomechanical properties, thickness, final product state, and preparation methods prior to clinical application.
The FDA Analysis of Current Data
Recently, the FDA has completed an analysis of patient-level data from real-world use of ADMs for implant-based breast reconstruction which suggests that two ADMs—FlexHD and Allomax—may have a higher risk profile than others.
Mastectomy Reconstruction Outcomes Consortium (MROC) is a prospective, cohort study collecting data from 11 centers, including nine academic hospitals, in the United States and Canada with high volumes of breast reconstruction. The purpose of this study was to evaluate outcomes in patients undergoing implant-based breast reconstruction after mastectomy. The study collected data on major complications including reoperation, explantation (implant removal), and infections. The FDA conducted an analysis on this data set comparing the complication rates between the control group which did not receive ADM and groups receiving one of the four ADM brands (FlexHD, AlloMax, SurgiMend and AlloDerm).
The FDA’s analysis of the MROC Study data showed significantly higher major complication rates of explantation, reoperation, and infections in patients with FlexHD and AlloMax brands of ADM two years after surgery, when compared to patients who received SurgiMend or AlloDerm brands, or no ADM. This increase in complications associated with FlexHD or AlloMax was seen across multiple sites. The limitations from the MROC study and the FDA’s analysis to attribute such increase to the specific ADM brands include non-randomized study design, potential differences in institutional or surgeon practices, and different sizes of the cohorts. Additionally, the FDA analysis was limited to immediate, two-stage, under-the-muscle, implant-based reconstruction with up to two-year follow-up.
In addition, the FDA is not aware of any information that shows an association between ADM use and development of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).