Maria Rachal, MedTech Dive: March 21, 2019.
When FDA Commissioner Scott Gottlieb and device center chief Jeff Shuren teased next week’s advisory panel tackling breast implant safety, it was tucked into a broader communication on postmarket safety efforts.
But in the four months since, FDA and a domino line of regulators and scientists have flagged upticks in known cases of breast implant associated anaplastic large cell lymphoma. The form of non-Hodgkin lymphoma has been traced to at least nine U.S. deaths. And University of Southern California plastic surgeons published the first known case of similar disease in a recipient of buttocks implants.
Last week, FDA announced an initiative to scrutinize device materials’ biocompatibility, including in the case of silicone breast implants, pointing to potential harmful autoimmune reactions to the devices.
With days before the two-day meeting, the FDA chided Sientra and Johnson & Johnson-owned Mentor for not adequately meeting post-approval study standards, citing low recruitment and poor data and follow-up rates. The only other market competitors are Allergan, whose textured breast implants lost CE marking last December, and privately held Ideal Implant, the newest entrant to the U.S. market.
The FDA is expected to release background materials and specific panel questions prior to the March 25-26 meeting, but none were published as of late Thursday morning ahead of what appears to be at least the eighth advisory committee meeting on breast implants since 1991, according to an agency timeline.
The agenda Monday is set to focus on BIA-ALCL, and Tuesday slated for discussion of everything else: use of MRI screening for silent rupture of silicone gel filled breast implants, surgical mesh in procedures like breast reconstruction and mastopexy, registries for postmarket surveillance, and real-world data and patient perspectives in regulatory decision making.
Here are some facts to know before the meeting.
What the Watchdogs Say
The panel could follow in the footsteps of those who weighed in on Essure, who advocated for better informed consent for patients; FDA ultimately issued the product a “black box warning,” which is reserved for calling out serious or life-threatening risks on a package’s label.
Madris Tomes, a former program manager at FDA who now analyzes adverse event data through her company Device Events, said the black box warning was not effective for patients in the case of Essure, and probably wouldn’t make a significant difference for potential breast implant recipients either.
“The patient won’t see a black box warning because they don’t see the box for the [product] that’s going to be implanted in them,” she said.
National Center for Health Research President Diana Zuckerman agreed that a black box is possible, and while FDA rarely recalls devices and already oversaw a long moratorium in this device category, she said a partial market removal of textured implants in particular wouldn’t be unheard of.
Tomes and Zuckerman think the benefit of registries is overstated, too.
“[The data] are not available to the typical doctor, and that’s not going to help with identification of autoimmune issues,” Tomes said. “Plastic surgeons are the ones using those registries, not rheumatologists and immunologists and family doctors.”
Zuckerman echoed those concerns.
“The data are not publicly available unless the American Society of Plastic Surgeons chooses to make it available,” Zuckerman said. “That’s a problem because of potential conflicts of interest that might result in not publishing results that are detrimental to ASPS.”
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