FDA Recommends Boxed Warnings for Breast Implants

Agency guidance seeks to inform women about implant risks

The FDA is recommending steps to ensure that women understand the risks of breast implants—including the addition of boxed warnings to product labels.

“We believe women should have thoughtful and balanced discussions with their health care providers about both the benefits and risks of breast implants based on clear and current information,” Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner, and Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement. “We have heard from many women that they are not fully informed of the risks when considering breast implants.”

In draft guidance proposing label recommendations, the FDA suggests:

  • A boxed warning noting that implants are not lifetime devices, that the odds of complications rise the longer a woman has the implant, that additional surgery may be required to address complications, that implants have been associated with anaplastic large cell lymphoma, and that implants may be linked with systemic symptoms such as fatigue or joint pain.
  • A patient decision checklist that can help guide discussion during a woman’s consultation with a surgeon. A checklist offers an opportunity to acknowledge individual risks of implants.
  • New rupture screening recommendations for silicone gel-filled implants. Current labeling recommends magnetic resonance imaging (MRI) screenings beginning three years after implantation and every other year thereafter. The new recommendations propose screening symptom-free patients using ultrasound or MRI five to six years after implantation and every two years thereafter. If a patient has symptoms at any time or inconclusive ultrasound results, an MRI is recommended. The new recommendations are based on data showing rupture rates are higher five to six years after implantation, expert advice, data suggesting that ultrasound is an effective screening method for asymptomatic patients, and poor patient compliance with existing recommendations.
  • Easy-to-understand descriptions of product ingredient information to help better inform patients of the types and quantities of chemicals and heavy metals in breast implants.
  • The inclusion of more detailed information on device cards that patients receive after surgery.

Once the guidance is finalized, manufacturers may choose to follow its recommendations or they may choose other methods of labeling their devices—as long as the labeling complies with applicable FDA laws and regulations.

Source: FDA, October 23, 2019