Two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis.
Patients implanted with FlexHD by MTF Biologics and AlloMax by BD had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other brands of surgical mesh or no mesh, the agency said late yesterday.
The mesh type in question is an acellular dermal matrix (ADM) made of human or animal skin from which the cells are removed and the support structure is left in place. The FDA has cleared some ADMs for use in certain types of surgeries, such as in hernia surgery, to reinforce tissue where weakness exists.
The agency has not cleared any ADM for use in post-mastectomy breast reconstruction but said some surgeons have been using it off-label for years. Now FDA is asking healthcare providers and patients to promptly report adverse events to better understand the risks.
“BD does not currently promote the use of AlloMax Surgical Graft in breast procedures, nor is it included in the product’s instructions for use,” BD spokesperson Troy Kirkpatrick said in an email to Medical Design & Outsourcing. “It is important to note that the safety notice does not apply to AlloMax Surgical Graft when used for supplemental support and reinforcement in soft tissue for hernia repair procedures, which is the primary use for the product as described in the instructions for use. BD stands behind the safety and effectiveness of AlloMax Surgical Graft in hernia repair procedures. BD will continue to keep safety and quality as top priorities as the company introduces new innovations in this segment.”
MTF Biologics did not respond to a request for comment.
The data that the FDA studied came from the Mastectomy Reconstruction Outcomes Consortium (MROC), a prospective cohort study collecting data from 11 centers, including nine academic hospitals, in the U.S. and Canada with high volumes of breast reconstruction. The study collected data on major complications of breast reconstruction after mastectomy, including reoperation, explantation and infections. Data from patients who received two other ADM brands, SurgiMend by Integra LifeSciences and AlloDerm by Allergan, were also included in the study.
FDA saw an increase in complications associated with FlexHD or AlloMax across multiple sites. The FDA acknowledged some limitations to the study, including non-randomized study design, potential differences in institutional or surgeon practices, and different cohorts’ sizes. The agency said its analysis was also limited to immediate, two-stage, under-the-muscle, implant-based reconstruction with up to two-year follow-up.
Multiple peer-reviewed publications in the medical literature suggest differences in safety profiles among different ADM brands consistent with the FDA’s analysis of the MROC Study data, the agency said. It is seeking additional clinical data to better assess the benefits and risks of ADMs used in implant-based breast reconstruction.
The FDA intends to hold a public meeting of the General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee in the coming months to promote discussion of currently available scientific information on ADM for breast reconstruction.
The agency does not recommend reoperation or removal of implanted ADM as a preventive measure.
Time to consider why there is not a 510(k) submission for a mesh used with breast reconstruction. Obviously, if there was a similar issue with penis reconstruction, there would be clinical data to support a submission to the FDA.