A FDA analysis has found Becton Dickinson and MTF Biologics acellular dermal matrix products may have a higher risk profile than similar devices when used in implant-based breast reconstruction.
The FDA safety communication covers the use of ADM products used in implant-based breast reconstruction. A study linked BD's AlloMax and MTF's FlexHD to higher major complication rates than devices made by companies including AbbVie's Allergan.
FDA, which has not cleared any of the devices for breast reconstruction, is asking healthcare providers to discuss the risks pre-surgery but advising against removal of implanted ADM as a preventive measure.
The off-label use of ADM in breast reconstruction was discussed at an advisory committee FDA held in 2019 to review the data on breast implants. By that time, researchers had already run a multi-site study of almost 1,300 patients to assess the risks and benefits of ADM. The authors said ADM had "gained widespread acceptance" and found no significant effect on complications.
Late last year, an analysis of an expanded dataset from the same multi-site study linked ADM use to a greater risk of major complications, particularly in patients with higher body mass index. The paper lacked a breakdown of the rate of complications linked to different ADM products.
FDA analyzed the patient-level data to determine if particular products underpinned the higher rate of complications in patients treated with ADM. The analysis "showed significantly higher major complication rates of explanation, 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." The differences were seen across multiple sites.
AlloMax is a product BD acquired in its takeover of CR Bard. The product is not in BD's online product catalog but is on a list of the company's brands last updated in July. MTF, a nonprofit, makes the FlexHD product. Johnson & Johnson's Ethicon licensed the U.S. rights to FlexHD in 2007 but does not list the product in its current catalog. AlloDerm and SurgiMend, the two ADM products with lower complication rates, are respectively sold by AbbVie's Allergan and Integra LifeSciences.
FDA said its analysis has limitations such as the non-randomized design, variable cohort sizes and potential for differences in the practices of institutions or surgeons to influence the results. Yet, the agency also noted that its findings are in line with the results of other studies, such as a retrospective analysis that linked FlexHD to increased risk of major infection.