FDA Takes New Steps on ADMs, Promises More

The FDA's recent safety communication about the use of Acellular Dermal Matrix (ADM) products in implant-based breast reconstruction is the more recent statement from the agency on the issue. Such statements carry implications for the practice of plastic surgery, and ASPS has been actively monitoring and weighing in on the discussion around ADMs.

Background

On March 31, the FDA issued a safety communication indicating some ADM products "may have a higher chance for complications or problems" compared to others, and in doing so, specifically reiterated that the "use of ADM in implant-based breast reconstruction," has not been cleared as safe and effective by the FDA and is considered an off-label use. This sentiment follows similar statements from the agency's recent past, where it has also simultaneously noted that ADM is essentially the standard of care for this surgery.

Use of ADMs

Implant-based breast reconstruction in today's practice relies heavily on ADMs, which have been used for nearly two decades in post-mastectomy procedures and have become the standard of care.

ADMs have regulatory approval for other uses, such as for the coverage of soft tissues and, most notably, hernia repair. Consequently, ASPS member surgeons may still elect to use ADMs in breast reconstruction or other breast surgery as an "off-label" use and facilities may purchase them for that purpose, because such decisions fall squarely within the practice of medicine.

An update to communication

In 2019, as part of a meeting of the FDA's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, the FDA indicated it had never cleared or approved any surgical mesh device – whether synthetic, animal collagen derived or human collagen derived – specifically for use in breast surgery. At the time, the FDA took the position that a Pre-Market Approval (PMA) evaluation is required for companies to market or promote the use of ADMs in breast surgery, a substantial change and increase in the regulatory complexity (and, thus, cost) of bringing new products to market.

As part of the hearing process, the FDA requested comments on the available literature and data that could or should be necessary to satisfy the requirements of a PMA and eventually approve indications for ADMs for use in breast surgery. ASPS and The PSF had a robust presence at the 2019 hearing and advocated for ADM as a critical option in implant-based breast reconstruction surgery.

In comments submitted following the hearing, the Society pointed out that human ADM has been used in post-mastectomy breast reconstruction for nearly two decades – a use which is supported by published scientific literature – and urged the FDA to retain the previously assumed regulation of human ADMs for breast reconstruction as tissue products (rather than as medical devices).

Following the meeting, ASPS also joined a group of stakeholders in calling on the FD to host a public workshop on the topic. The Society also pushed back against a proposal by the state of Oregon's Medicaid program to drop coverage for ADMs – a development for which the FDA's 2019 meeting was the catalyst.

Plastic surgery's input is critical

Given the importance of human ADMs within the specialty, it is imperative that all plastic surgeons participate in registry and data initiatives. ASPS/PSF leadership has begun working to position ASPS members to be able to collect real-world data and patient reported outcomes on ADM. It is those tools and the science they support that can help ensure that the use and effectiveness of ADMs is accurately demonstrated. The answer to questioning of ADM's use in breast reconstruction lies within our own practice data. Continued evidence supporting the use of ADMs' position as the standard of care in breast reconstruction will be critical in the effort toward regulatory approval.

Next steps

The FDA has communicated that it intends to host a public meeting in the coming months to "promote discussion of currently available scientific information on ADM for breast reconstruction. In advance of this meeting, and in the wake of the agency's March safety communication, ASPS president Joseph W. Losee, MD, FACS, FAAP, convened an ASPS ADM and Surgical Meshes in Breast Surgery Task Force that will harmonize current ASPS and PSF efforts to explore and articulate the present scientific, safety, regulatory and reimbursement issues surrounding ADM. Additionally, ASPS/PSF will actively collaborate with members, expert stakeholders and manufacturers to ensure key data elements related to ADM are added into the Plastic Surgery Registries Network (PSRN).