The FDA Proposes New Safety Information for Breast Implants, Including Warning Labels

Kaitlin Clark

It's been a controversial and emotional year for breast implant devices, and those who have received them.

In February, the Food and Drug Administration issued a new update, citing more cases of a rare lymphoma cancer, BIA-ALCL, associated with breast implants. The next month, the FDA hosted a public, two-day public advisory committee meeting in Maryland, attended by plastic surgeons, manufacturers, and included personal testimonies from women who attribute their health problems to their implants.

San Francisco-based, board-certified plastic surgeon David A. Sieber attended the March meeting and agrees that more effort needs to be put into patient education, industry-wide. According to Sieber, patients at the meeting were not only sharing that they were uninformed of risks, but that "they also felt like many plastic surgeons were being very dismissive of their symptoms."

Fast forward to July, when the FDA requested a voluntary recall of specific types of textured implants from one manufacturer, Allergan, whose implants were found in an FDA analysis of data to present about six times the risk of BIA-ALCL when compared to textured implants from other manufacturers.

Allergan issued a statement on July 25 about the voluntary recall: "Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA)...Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns...Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients."

And on October 23, the FDA amped up its efforts to educate women about the risks that all saline and silicone gel-filled breast implants pose by proposing draft guidance for new labeling recommendations to manufacturers, including a boxed warning on implant packaging and a "patient decision checklist," which is intended to standardize and guide doctor-patient conversations by outlining all potential risks.

"We have heard from many women that they are not fully informed of the risks when considering breast implants," said Amy Abernethy, principal deputy commissioner of the FDA, and Jeff Shuren, director of the FDA's center for devices and radiological health in its official statement on October 23. "They've stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves."

William Adams, an associate clinical professor of plastic surgery at UT Southwestern Medical Center, and board-certified plastic surgeon in Dallas, acknowledges that while many surgeons do "an excellent job" with patient education, there can still be "a lot of issues and roadblocks" in the process of achieving a truly informed patient. At his practice, they're "always looking at ways to improve and for different tools to make it better and easier for patients to assimilate all the information."

The draft guidance proposal for recommended boxed warning, similar to those wrapped on cigarette boxes, would feature three key risks that the FDA believes are critical for a patient to understand, including:

  • All implants have a shelf life; they are not lifelong devices

  • Risk of developing complications can increase with longevity, which may require additional surgery to address

  • Implants have been associated with risk of BIA-ALCL, as well as fatigue and joint pain

Both Sieber and Adams agree that those three points are crucial for a patient to understand, but they are skeptical about how effective a boxed warning label will actually be for patient education. According to Adams, "the patient never sees the box," and Sieber points out that Botox also has a black box warning, yet is still commonly used off-label across the industry.

Another new FDA recommendation is the proposed patient decision checklist, which would be included in printed patient information booklets, and available to patients during consultations for surgery. The checklist would formalize doctor-patient communication protocol by requiring the physician to review the checklist with their prospective patient, and both patient and surgeon providing signatures acknowledging the risk-benefit discussion.

Adams calls the checklist "a start," but believes that what surgeons really need is "a higher-level way to deliver the information" rather than a basic outline.

Currently, these new FDA guidelines are only drafted recommendations, which are available for public comment, with the goal of collecting information from "patients, manufacturers, the medical community and other stakeholders," according to its official statement. After a 60-day period, the FDA will evaluate all input to formalize an industry-wide mandate.

"I think the FDA is trying to do the right thing," says Adams. "They're trying to be objective, to involve a lot of different stakeholders, to listen to everybody and look at studies to determine the next best step."

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Originally Appeared on Allure