SILVER SPRING, Md. — More robust data are needed on breast implants, including more complete patient histories to determine what factors increase risk of breast implant-associated illnesses, members of an FDA advisory committee said Monday.
Having better information on patients before and after implantation surgery should improve estimates of individual patient risks associated with breast implants, especially breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness.
On the first day of a two-day meeting of the FDA’s General and Plastic Surgery Device Panel, members were charged by the FDA to address how to utilize breast implant registries for data generations about patient outcomes, identify potential shortcomings of the registry system, and discuss the role that types of implants (textured versus smooth) may play in the development of BIA-ALCL.
This meeting came on the heels of recent FDA warning letters issued to two breast implant manufacturers, Mentor Worldwide and Sientra, for “failure to comply with post-approval study requirements.” Last month, France pulled Allergan textured implants off the shelves, citing safety concerns.
But the FDA panel did not go that far. While some patient advocates encouraged the FDA to pull textured implants off the market, this idea was quickly shut down by committee members.
Mary McGrath, MD, of the University of California San Francisco, said textured breast implants should remain an option for physicians treating patients with bilateral mastectomies.
“The most straightforward reconstruction is going for an implant,” she said. “A smooth surface implant doesn’t sit in the right place, but texturing gives us the opportunity to fix the implant and allow it to stay in the right place.”
Allergan’s textured implant, Biocell, was under the most scrutiny, as experts cited the December 2018 CE mark withdrawal and a “voluntary recall” for Biocell and Microcell products. This affected 38 countries total, including 33 in Europe.
Mark Clemens, MD, of MD Anderson Cancer in Houston, identified 152 cases and five deaths in the U.S. attributable to BIA-ALCL. He put the focus mainly on textured implants, saying that there were “no confirmed smooth implant ALCL cases to date,” only cases among patients with “unknown history.”
Clemens also shared data that showed an increased risk of BIA-ALCL associated with Biocell implants compared to all other implants.
During the discussion, panel member Stephen Li, PhD, of Biomaterials in Palm Harbor, Florida, pointed out that other implants around the world have the same texture, but not the same clinical performance, and said that “something else was going on” in addition to texture or else it was “incredibly bad luck.”
Unclear Scope of the Problem
Most experts characterized BIA-ALCL as a rare disease for women with breast implants, with an undetermined etiology.
Although manufacturers touted a “14-point aseptic technique” during surgery that reduces the risk of BIA-ALCL, including changing gloves, antiseptic solutions and minimal touch, Clemens said that “no strategies have been determined” for an operative technique that clearly cuts BIA-ALCL risk.
Clemens added that when addressing risk, the panelists should be talking about “risk per manufacturer,” saying that “9 out of 10” of the cases of BIA-ALCL were associated with Allergan implants.
McGrath thought the problem was more related to “surface area,” highlighting that 10% of implants in the U.S. are textured, but 95%-100% of BIA-ALCL cases are from textured implants.
Marc E. Lippman, MD, of Georgetown University Medical Center in Washington, said that it remains to be seen how much “true incidence” is of this disease, emphasizing the need to have more information about its etiology.
“Is telling someone they have a 1 in 3,300 chance of getting lymphoma, a reason to ban [implants] or change informed consent?” he said. “I think that’s an extraordinary overreaction.”
More Complete Data Collection
The panel came up with several “inputs and outputs” for a registry to address systemic complications from breast implants:
- Demographic data for patients at baseline, before the implant
- Disease process leading to the implant
- Implant characteristics from the manufacturer
- Family history of rheumatologic disease or autoimmune disease (a potential contributing factor to systemic complications)
- Macroscopic complications well-recognized with implants
- Breast implant illness and BIA-ALCL occurrence
Andrea Pusic, MD, of the Plastic Surgery Foundation, said the National Breast Implant Registry (NBIR) will begin collecting device tracking information on July 1, 2019, she said. Pusic added that the NBIR was started in October, with 200 surgeons joining since then.
“Our plea to the panel is that we set the bar that participation in the National Breast Implant Registry is standard of care. Then we can bring all the community of surgeons together to participate,” Pusic said.
Pusic added the goal of the NBIR was to provide both “broad” and “deep” data — broad data from detailed forms filed as part of the surgery. The “deep” data would come in the form of “larger cohorts, nested within the registries” that could address specific problems.
Karla Ballman, PhD, of Weill Cornell Medicine in New York City, sounded a note of skepticism. Citing her own experience with cancer registries, she questioned whether “to make it mandatory without incentives” can work. Most panel members agreed that, in certain cases, a representative sample of patient data could provide adequate information.
During public comments, patient advocates urged other safety measures, such as boxed warnings and updates to the informed consent process. The panel is scheduled to take up these and other issues on Tuesday.