Over concerns about the risks of breast implants, the FDA restricts breast implants sales and distribution of the devices to healthcare providers and facilities that conduct decision-making with each patient.
According to the FDA, restrictions are needed since links between breast implants and a type of cancer make it difficult to determine the safety and efficacy of the device.
The FDA also revealed the decision to implement a boxed warning, following recommendations in its final guidance published last year, and its “inadequate” post-approval studies.
A panel of FDA advisers largely downplayed talk of banning textured breast implants in the United States but expressed support for safety advocates’ calls for more transparent, mandatory, and standardized informed consent.
An immune system cancer panel discussion was held as part of a two-day event on assessing, diagnosing, treating, and tracking cancers often associated with textured breast implants and breast implants with textured surfaces (BII). Based on breast implant-related adverse event reports, the FDA says the latter term originates from social media posts and could be used to describe more than 80 different symptoms.
As part of this action, FDA established an advisory panel in 2019 to consider how to respond to cases of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In the 18 months following the advisory panel meeting, the FDA formalized the recommendations made at the event. In the 18 months following, the FDA formalized the recommendations made in 2019.
The order, which was issued Wednesday, requires that patients only be provided with health information using the patient brochure ‘Patient Decision Checklist’ before they can shop for and purchase breast implants. The breast implant device checklist should be provided to prospective patients to ensure that they are adequately informed about “the risks, benefits, and other information that come with the breast implant device.”
Initiate and sign the checklist after the patients have had the opportunity to do so. FDA last year created an example checklist in which the patient must indicate that they have received information regarding the overall incidence rate of BIA-ALCL and the rates for the particular breast implant being used. Also on the checklist should be the signature of the physician implanting the device.
The FDA revised the labeling of breast implants in the second set of changes. According to the 2020 guidance, manufacturers must add a warning box containing information about the “significant risks” of breast implants. In response, the FDA requested information from Allergan, J&J’s Mentor, Ideal Implant, and Sientra.
The labeling includes updated information on silicone gel-filled breast implants that rupture and a detailed listing of the materials used in the devices.
The FDA also provided a post-approval study update. According to the agency, researchers from Allergan, J&J, and Sientra did not make adequate progress in their studies. Nevertheless, the survey at Ideal Implant has been successful.
Approximately 50,000 MDRs were received by the FDA each year related to breast implants in 2017. While that number includes all adverse reactions, it contrasts with the 660 total cases reported by the FDA in its press release in February.
A 2019 FDA expert advisory panel took into account the input of dozens of women who experienced cancer or systemic symptoms after they acquired breast implants. The FDA developed labeling guidance for breast implants based on that feedback. In issuing labeling guidelines, the FDA responded to concerns that some patients may not be receiving or understanding the risks associated with devices.
The risk of developing BIA-ALCL is considered low, but the cancer is severe and can lead to death, FDA has said.