Today, the FDA released a 21-page document, “Breast Implants – Certain Labeling to Improve Patient Communication,” directed toward breast implant manufacturers and the general public. This draft version allows 60 days for all to comment before the statement is finalized.
According to an FDA statement, the intention behind the guidance is to protect women’s health by ensuring women have access to “complete information” regarding the risks and benefits of breast implants. This is the agency’s first update to breast implant consumer information practices since 2006.
The guidance includes a product label black box warning, the FDA’s strongest form of warning for consumers, and was developed in response to a two-day public advisory panel hearing held by the agency in March at which dozens of affected women testified about the potential dangers of breast implants.
The agency wants the black box to clearly communicate the following information:
- breast implants cannot be expected to last for a lifetime
- the chance of complications arising increases the longer a patient has an implant
- additional surgery may be required to address implant-related complications
- breast implants may be associated with systemic symptoms like fatigue or joint pain
- breast implants have been associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
The black box warning is perhaps the most dramatic but certainly not the only agency recommendation. The FDA likewise suggested inclusion of a patient decision checklist at the end of a patient information booklet or brochure to encourage patient-doctor consultation, more user-friendly access to ingredient information including chemicals and heavy metals found in or released by breast implants, and the addition of more comprehensive information on the “device cards” given to patients post-surgically.
For healthcare providers, the agency proposed revisions to existing rupture screening imaging protocols for patients with silicone gel-filled implants to reflect the most current data on the timing of implant ruptures.
The agency has come under increasing pressure in recent years alongside mounting evidence of breast implant dangers, including a March report by the International Consortium of Investigative Journalists (ICIJ) that the FDA had withheld hundreds of thousands of breast implant incidents from the public eye.
In March, the FDA issued warning letters to two implant manufacturers regarding their failure to comply with post-approval safety research requirements.
In July, the FDA called on manufacturer Allergan to recall its Biocell textured breast implant after it was linked to BIA-ALCL. Textured implants are much more common in Europe where they’ve already been recalled by many countries and represent only 5 percent of implants used in the United States as of a July New York Times report.
Public comments on the draft guidance can be submitted through December 23 at www.regulations.gov under docket number FDA-2019-D-4467.
Breast implant surgery is the leading type of cosmetic surgery in the United States, with about 100,000 post-mastectomy reconstructive surgeries and an additional 300,000 breast augmentation procedures performed annually. The agency’s recommendations apply to both with saline (salt water) and silicone gel-filled implants.