The agency is recommending "boxed warnings", the strongest form of warning required by the FDA for product labeling.

By Faith Brar
October 24, 2019

The U.S. Food and Drug Administration (FDA) is cracking down on breast implants. The agency wants people to receive stronger warnings and more details about all the possible risks and complications associated with these medical devices, according to new draft guidelines released today.

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In its draft recommendations, the FDA is urging manufacturers to add "boxed warning" labels on all saline and silicone gel-filled breast implants. This type of labeling, similar to the cautions you see on cigarette packaging, is the strongest form of warning required by the FDA. It's used to alert providers and consumers about the serious risks associated with certain drugs and medical devices. (Related: 6 Things I Learned from My Botched Boob Job)

In this case, the boxed warnings would make manufacturers (but, importantly, not consumers, aka women actually receiving the breast implants) aware of complications associated with textured breast implants, like chronic fatigue, joint pain, and even a rare type of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). As we've previously reported, half of all BIA-ALCL cases reported to the FDA have been diagnosed within seven to eight years after breast implant surgery. While this type of cancer is rare, it's already taken the lives of at least 33 women, according to the FDA. (Related: Is Breast Implant Illness Real? Everything You Need to Know About the Controversial Condition)

Along with the boxed warnings, the FDA is also advising that breast implant manufacturers include a "patient decision checklist" on product labels. The checklist would explain why breast implants are not lifelong devices and notify people that 1 in 5 women will need to have them removed within 8 to 10 years.

A detailed material description is also being recommended, including the types and quantities of chemicals and heavy metals found and released by the implants. Finally, the FDA suggests updating and adding labeling information on screening recommendations for women with silicone gel-filled implants to watch for any rupturing or tearing over time. (Related: Getting Rid of My Breast Implants After a Double Mastectomy Finally Helped Me Reclaim My Body)

While these new recommendations are rough and have yet to be finalized, the FDA hopes the public will take time to review them and share their thoughts over the next 60 days.

"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 health care decisions that fit patients' needs and lifestyle," Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D.—FDA principal deputy commissioner and director of the FDA's Center for Devices and Radiological Health, respectively—wrote in a joint statement on Wednesday. (Related: I Got My Breast Implants Removed and Feel Better Than I Have In Years.)

If and when these warnings do go into effect, however, they won't be mandatory. "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," added Drs. Abernethy and Shuren. In other words, the FDA's draft guidelines are just recommendations, and even if/when they are finalized, manufacturers won't necessarily be legally required to follow the guidelines.

Basically, it will be up to doctors to read the warnings to their patients, who will likely not see the implants in their packaging prior to surgery.

At the end of the day, however, this is definitely a step in the right direction by the FDA. Given the fact that over 300,000 people choose to get breast implants every year, it's about time people understand exactly what they're signing up for.

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