The US Food and Drug Administration (FDA) is taking steps to improve the safety of women with breast implants. In a draft guidance, the agency is recommending proposed labeling changes that would better highlight the benefits and health risks associated with breast implants. The FDA also recommends improved access to information to better inform women who are considering breast implants.
Using input from a public advisory panel meeting held earlier in the year, the FDA compiled a list of several recommendations to help women make more informed decisions about breast implant devices.
Boxed Warning
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The FDA recommends that manufacturers of implant devices include boxed warnings that indicate certain risks and highlight that breast implants are not lifetime devices and that the chances of complications associated with such devices are positively correlated with the length of time the patient has had the implants, which may require additional surgical intervention. In addition, the warning labels should call out that implants are linked to the risk of developing breast implant-associated anaplastic large cell lymphoma and associated symptoms such as fatigue or joint pain.
Patient Decision Checklist
The FDA recommends that manufacturers include a patient decision checklist at the end of patient informational booklets and brochures. This would reinforce the risk and benefits of breast implants and help patients make informed decisions based on that information.
Revisions to Screening Recommendations
Patients with silicone-filled breast implants who do not have symptoms should be screened at 5 to 6 years after implantation and every 2 years thereafter with the use of ultrasound of magnetic resonance imaging, according to the FDA recommendation. Previous recommendations suggest that patient screening should take place 3 years after initial implantation and every other year thereafter. The new screening recommendations are a result of data on rupture rates provided by the American College of Radiology that indicate a higher rupture rate 5 to 6 years after implantation.
Product Ingredient Information
In the draft guidance, the FDA also recommends that manufacturers adjust current device labels to include product ingredient information in an easy-to-understand manner. The authors of the statement note that “although this information is currently publicly available online in the FDA’s Summary of Safety and Effectiveness Data for each of the approved breast implants, we’re recommending that product ingredient information be included in the patient labeling in a format that is easy to understand to increase patient access to this information.”
Patient Device Cards
Previously, the FDA recommended that patients be provided with a device card after surgery that included information about their implants such as the style, size, and serial number of the devices. “In today’s draft guidance, we’re proposing that manufacturers include more information on the device card, including the unique device identifier of the product, the boxed warning, and also provide web links to the patient decision checklist,” noted the agency…
The FDA’s draft guidance is available for public comment. After guidance finalization, manufacturers may either use the final guidance recommendations or use other methods of labeling as long as alternate labeling complies with applicable FDA laws and regulations.
Reference
Abernethy A, Shuren JE. Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants. United States Food and Drug Administration website. https://www.fda.gov/news-events/press-announcements/statement-agencys-continued-efforts-protect-womens-health-and-enhance-safety-information-available. Updated October 23, 2019. Accessed November 12, 2019.
