FDA issues new safety communication on ADMs
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 explanation, 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. Please review the safety communication for the FDA's conclusions and be sure to discuss these risk profiles with your patients.
- 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. You may wish to check with your hospital and medical liability provider for any additional information.
- 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? Absolutely yes. 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.
ASPS continues to support the recommendation for a transparent and complete patient-centered education and informed consent process. Every patient should have the opportunity to ask all questions and then elect to proceed with the procedure. ASPS offers an informed consent resource specific to ADMs in breast reconstruction. It provides an opportunity to review the potential benefits and risks of ADMs, and ensures the patient and surgeon make a joint decision about its use with the best available evidence.
- 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.
- What additional, proactive steps can I take to support patient safety? The FDA encourages prompt reporting of adverse events to better understand the risks of breast surgery and breast reconstruction with ADM. Medical device reports can be completed through the MedWatch Voluntary Reporting Form.
FDA notes that additional clinical data are needed to better assess the benefits and risks of ADMs used in implant-based breast reconstruction. ASPS encourages all ASPS members to enter their data for all breast implant-related surgery procedures, including use of ADM in implant-based reconstruction, into the National Breast Implant Registry (NBIR). The NBIR collects clinical, procedural and outcomes data at the time of operation and any subsequent reoperations for all U.S. patients receiving breast implants. Plastic surgeons who enter data into the NBIR can compare their practice performance and outcomes to the registry aggregate.
- What next steps I should watch for? The FDA will hold a public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in the coming months to promote discussion of currently available scientific information on ADM for breast reconstruction. ASPS will actively monitor the status of this meeting and participate on behalf of its members.
In summary, as a result of FDA analysis of real-world data that suggests some ADMs may have higher risk profiles than others, the agency has not cleared ADMs for use in breast surgery and their use for such purpose is considered "off-label." Additionally, the FDA says patients should continue to be fully informed of the risks and benefits of ADM in breast surgery.
ASPS will continue to keep members informed on this topic with accurate information that we hope will be useful for your respective practice. If you have any further questions, please do not hesitate to contact our Health and Payment Policy Department at (847) 981-5401.