New FDA Communications about Acellular Dermal Matrices for Breast Surgery
Dr. Kenneth Hughes is an expert in breast augmentation surgery and breast augmentation revision surgery. He also wrote the chapter on breast augmentation revision surgery with the use of acellular dermal matrices. Therefore, Dr. Hughes frequently advises of the latest developments of acellular dermal matrices in the breast augmentation and reconstruction realms.
The ASPS recapped some of the recent FDA communications below. ASPS also provides some its recommendations below.
On March 31, the FDA released a new safety communication about acellular dermal matrices (ADMs) in implant-based breast reconstruction surgery. This document is now available to healthcare providers, patients and caregivers on the FDA’s Medical Device Safety webpage.
The FDA issued the communication following the agency’s analysis of patient-level data from the multi-center Mastectomy Reconstruction Outcomes Consortium (MROC) study, which showed significantly higher rates of major complications – including explantation, reoperation and infections in patients with some brands of ADM. According to the FDA, the root cause of the difference in complication rates among different brands of ADM is not known at this time. Although FDA acknowledges the study and analysis has limitations, multiple peer-reviewed publications in the medical literature also suggest safety profiles vary among different brands of ADM – as well as compared to no ADM use – which is consistent with the FDA’s analysis of the MROC Study data.
Given the importance of human ADMs within a plastic surgery practice, the ASPS created the following FAQ to help educate our members.
Can I still use ADMs? Depending upon the ADM, yes, as most ADMs have other approved uses, such as for the coverage and support of soft tissues. This new safety communication does not change the approval status of any ADM, and the agency reiterated that ADMs have not yet been cleared or approved for use in breast surgery.
What new information should I be aware of? The FDA cautions surgeons that real-world data suggests some ADMs may have higher risk profiles than others.
Can I still use ADMs in the breast? Yes, ADMs may still be used in the breast. Although the FDA reiterated that ADMs have not yet been cleared or approved for use in breast reconstruction surgery, their availability for other uses allows surgeons to make the decision to use ADMs in an “off-label” manner in breast reconstruction surgery. The agency’s new safety communication does not change the approval status of ADM but raises awareness that real-world data suggests some ADMs may have higher risk profiles than others.
Is the term “off-label” appropriate for ADMs in the breast? Yes. As noted above, because ADMs are available for other surgical uses, but do not have an approved indication for use in breast reconstruction surgery, their use in the breast is considered “off-label.”
If I elect to use an ADM in the breast, do I have to notify patients that it is not currently approved by the FDA for this purpose? In its latest safety communication, FDA recommends that healthcare providers discuss the potential benefits, risks, limitations and consequences related to ADM in breast reconstruction with patients prior to the procedure as part of an informed, shared decision-making process.
Does the FDA recommend reoperation or removal of implanted ADM? No, the FDA does not recommend reoperation or removal of implanted ADM.
Are any of these complications related to BIA-ALCL? The FDA says it is not aware of any risks or association between ADM use and the development of BIA-ALCL.