FDA proposes new breast implant labeling with a boxed warning


The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”

Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.

Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”

“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”

The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.

Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”

Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.


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