ADM Update: The use of acellular dermal matrices (ADMs)
On March 26, 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 indicated for use in breast surgery. As such, the FDA is taking the position that a Pre-Market Approval (PMA) evaluation is required for companies to market or promote the use of acellular dermal matrices (ADMs) in breast surgery.
Currently, the FDA has not banned the use of ADMs. Rather, ADMs may still be marketed and promoted for other approved uses, such as soft tissue coverage. Given that ADMs have regulatory approval for other uses, ASPS Member Surgeons may still elect to use ADMs in breast reconstruction or other breast surgery as an "off-label" use. This is entirely within the discretion of the physician in the practice of medicine, which is not regulated by the FDA.
Similarly, hospitals and other facilities may continue to purchase ADMs and make them available to surgeons who wish to use them for breast surgery.
As part of the hearing process, the FDA requested comments on the evidentiary 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. In comments submitted following the hearing, the ASPS: (i) pointed out that human ADM has been used in post-mastectomy breast reconstruction for nearly two decades – a use which is supported by the published scientific literature; (ii) and urged the FDA to retain the previously assumed regulation of human ADMs for breast reconstruction as tissue products (rather than as medical devices). Notwithstanding the ASPS submission, it is now clear that the FDA considers ADMs in breast surgery to be a medical device requiring a PMA.
At the time of publishing, ASPS is aware that at least one company that manufactures human ADMs has indicated that the company will pursue Pre-Market Approval (PMA) for the use of human ADMs in breast surgery and will cease marketing and promotion of ADMs for breast surgery.
Given the importance of human ADMs within a plastic surgery practice, the ASPS has created the following FAQ document to help educate our members.
- What is a PMA? A premarket approval (PMA) is a process used to demonstrate that a medical device sold in the United States is safe and effective. As part of the PMA process, a company that manufactures devices is required to conduct clinical studies to demonstrate safety and effectiveness. The FDA also reviews all valid scientific evidence to determine whether there is reasonable assurance of the safety and effectiveness of a device under its condition of use. Medical devices are classified according to levels of risk, with Class III devices being in the highest risk category. As breast implants are Class III devices, an ADM used in association with a breast implant is also considered a Class III device and must meet the same criteria to obtain an approved indication.
- Can I still use ADMs? Depending upon the ADM, yes, as most ADMs have other approved uses such as for the coverage of soft tissues.
- Can I still use ADMs in the breast? Yes, ADMs may still be used in the breast. Although the FDA's position is that ADMs have not been approved for use in breast surgery, their availability for other uses allows surgeons to make the decision to use ADMs in an "off-label" manner in breast surgery.
- 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 surgery, their use in the breast is considered "off-label."
- Do physicians face the potential for legal exposure by using "off-label" devices in their practices? The FDA does not regulate the practice of medicine and the federal Food, Drug, and Cosmetic Act of 1938 does not create physician liability for the "off-label" use of devices. Of course, there have been cases where surgeons have faced legal exposure as a result of an adverse reaction related to "off-label" use. Legal theories used in these lawsuits include medical negligence and failure to provide adequate informed consent.
- 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? ASPS believes that the use of an ADM in breast reconstruction should be discussed with the patient prior to the procedure, as part of the informed consent process which includes a discussion of the risks, benefits, limitations and potential consequences of the procedure, with the patient having the opportunity to ask all questions and then electing to proceed with the procedure. The ASPS is currently revising its informed consent forms to reflect the current regulatory environment.
- Will insurers still reimburse for the ADM products used in the breast? There is no reason for an insurance company to decline reimbursement based solely upon an ADM being used "off label" in breast surgery. In determining coverage of ADMs for breast reconstruction, each insurer examines key studies to support or decline coverage. As ASPS noted in its comments to the FDA, that "vast majority of insurance companies cover the procedure" and, because of its use in approximately 75% of breast reconstruction cases, the use of ADMs is considered a Standard of Care.
- Will insurers still reimburse professional fees for the placement of ADM in the breast (CPT 15777)? Reimbursement of professional fees should be treated by insurance companies in the same manner as reimbursement for the cost of the product itself, in a manner consistent with Question 7, above.
- What has prompted the communications from ADM manufacturers? Communications from companies are a response to the FDA's position that it considers ADMs to be medical devices that require a PMA for an indication in breast surgery.
In summary, the FDA determined that no ADM has been approved for use in breast surgery. Approval will require that PMA's be performed by companies to establish safety and efficacy of ADM use in breast reconstruction. However, ADMs will still be available for sale due to their approved indication for other uses, such as the coverage of soft tissues. It is the shared decision of the surgeon and his or her patient to determine whether to use an ADM for a breast procedure. Such use, as noted above, would be considered "off label."
The 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.