FDA Recommends New Labeling Guidelines For Breast Implants

The Food and Drug Administration (FDA) has issued a new draft guidance for labeling recommendations for breast implants to manufacturers that they hope will provide patients with more information on the benefits and risks associated with them.¹

The new draft guidance offers measures to make sure women have access to pertinent information concerning the implants, such as suggesting manufacturers include updated guidelines for rupture screenings. They proposed that patients without symptoms be screened using either ultrasound or MRI at 5-6 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 also hopes to provide easier access to information on both saline-filled and silicone gel-filled breast implants.

The new recommendations come after the FDA came under scrutiny for not addressing patient complications with breast implants. In March, the agency held a hearing where patients brought multiple issues to light about their breast implants and subsequent illnesses. The FDA came out of the hearing demanding more information on cancer and illness caused by breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). While the FDA announced that it would take action against BIA-ALCL, the organization had yet to issue new action until this week.

“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 said 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 “The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and healthcare professionals when breast implants are being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.”

One of the major recommendations proposed by the FDA is to provide a boxed warning on the label of the breast implant. The label would include a warning that breast implants are not lifetime devices and the risk of developing complications increases the longer a patient uses the implant, which could lead to more surgery to address these complications. The warning would also include that breast implants have been associated with BIA-ALCL.²

The FDA also recommends a patient decision checklist, which will allow patients to easily understand the risks associated with the breast implant, and if the implant is right for them. The agency recommends that the information in the checklist should include situations where the device should not be used, what makes a successful breast implant candidate, risks of undergoing breast implant surgery, importance of physician understanding and experience with breast implants, risk of BIA-ALCL, and alternative options to using breast implants. This checklist would also have the patient and physician initial that they have gone through the checklist together.

Other recommendations included adding product ingredient information simplified in a way for patients to read and understand. The abridged information is a way to provide patients with access to information that they otherwise wouldn’t get or have to ask their physician to explain to them. The FDA also would like manufacturers to provide the device’s unique identifier on the patient card in order for both the patient and physician to better track the device's information.

“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 their statement. “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.”

References

• 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 24, 2019.
• 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 25, 2019.