FDA Recommends Boxed Warning, Additional Labeling Measures for Breast Implants

The FDA has issued a draft guidance to propose labeling recommendations, including a boxed warning, to breast implant manufacturers in an effort to help patients understand the benefits and risks of these devices, the agency announced in a statement.¹

The draft guidance includes measures to help ensure women have access to the information on the benefits and risks of breast implants, including recommendations that manufacturers incorporate a patient decision checklist in the device’s labeling, and updated guidelines for patient screening for ruptured devices.

“We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information,” the agency stated in a press release. “The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and healthcare professionals when breast implants are being considered.”

In the proposed labeling recommendations, the FDA recommends that boxed warnings be included in the labeling for breast implants, with information including that breast implants are not lifetime devices and the risk of developing complications increase the longer a patient has the implant and, therefore, additional surgery may be required to address such complications.

The agency also stated that implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (ALCL) and may be associated with systemic symptoms, such as fatigue or joint pain. In 2017, the FDA released a warning advisory that breast implants may increase an individual’s risk of developing ALCL.

Another recommendation listed in the draft guidance is that manufacturers include a patient decision checklist at the conclusion of a patient informational booklet or brochure to help guide discussion during a patient consultation with a surgeon, as well allowing the patient to acknowledge all of the associated risks.

Regarding rupture screening for patients with silicone gel-filled breast implants, the FDA also proposed revising these recommendations. The existing opinion states that labeling include the method(s) and frequency of rupture screening, and current approved labeling recommends MRI screenings for patients starting 3 years after getting implants and every other year thereafter.

With the latest draft guidance, the agency proposed that patients without symptoms be screened using either ultrasound or MRI at 5 to 6 years after receiving implants and then every 2 years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended, the FDA stated. The update to these recommendations is based on results of increased rupture rates at 5 to 6 years after implantation, as well as data suggesting that ultrasound is an effective screening method. Recommendations were also provided by the American College of Radiology and from an FDA panel meeting that was held earlier in 2019.

The FDA also recommended, in the draft guidance, that breast implant manufacturers include product ingredient information in the device’s labeling so that it is simplified enough for patients to understand. The abridged information could better information patients of the number and types of chemicals and heavy metals that are in these devices.

The final recommendation in the draft guidance proposes that manufacturers include more information on the patient device card to include the unique device identifier of the product, the boxed warning, and also provide web links to the patient decision checklist, boxed warning and labeling for the specific implant so that patients may easily access any updated information on the manufacturer’s website, the agency stated in the press release.

“Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making healthcare decisions that fit patients’ needs and lifestyle,” the agency concluded in the press release. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”

When final, the recommendations in the guidance will supplement or, in some cases, replace recommendations in FDA’s Guidance Saline, Silicone Gel, and Alternative Breast Implants guidance, which were published in 2006.

References

1. Statement on the Agency’s Continued Efforts to Protect Women’s Health and Enhance Safety Information Available to Patients Considering Breast Implants. FDA. Published October 23, 2019. https://bit.ly/35WzONY. Accessed October 23, 2019.
2. Breast Implants-Certain Labeling Recommendations to Improve Patient Communication: Draft Guidance for Industry and Food and Drug Administration Staff. FDA. Published October 23, 2019. https://bit.ly/33V42z1. Accessed October 23, 2019.