Medical Device Daily Washington Editor
WASHINGTON – The FDA’s General and Plastic Surgery Devices advisory panel on Wednesday evening voted to recommend that silicone gel breast implants manufactured by Mentor (Santa Barbara, California) be allowed back on the market, potentially lifting a 13-year ban on the devices.
That by itself is pretty big news.
However, the larger story – and the one leaving many who follow the industry scratching their heads – is that while the panel voted 7-2 in favor of Mentor s product, it also voted 5-4, the previous day, against approval for a similar type of silicone gel product from Inamed (also Santa Barbara).
In 1992 the agency limited the use of gel implants to women who had mastectomies and for some patients enrolled in clinical trials. The industry standard since that time has been saline implants. In 2004, the FDA rejected the same panel’s recommendation for approval of Inamed’s implants.
So what comes next?
The FDA now has 90 days to review the results of the panel s mixed recommendations and decide to approve Mentor s device or reject it. And because the FDA is not bound by its panels recommendations, the agency could still approve one company’s products, approve both companies products or give its thumbs-down to both – sending both firms back to the regulatory drawing board.
The vote to support Mentor’s application came with a laundry list of nine conditions. Some of these conditions include: a hands-on education program for board-certified plastic surgeons; additional data collection; a patient education program and consent process; FDA tracking of the devices, including implant extraction patients in case study data; and a recommendation for MRIs at five years to look for evidence of silent rupture.
“They are two different devices; they're made by two different companies; their chemistries are different, and there are manufacturing differences,“ said panel member Stephen Li, PhD, president of Medical Device Testing and Innovations (Sarasota, Florida), following the panel’s vote on Mentor’s application an apparent attempt to explain the different conclusions. The implant data [from Mentor], though it was short-term, like yesterday’s, the difference is [Mentor] had extremely low rupture rates. What we didn’t have yesterday [in Inamed’s presentation] is excellent fatigue testing.
Li said he thought Mentor’s post-approval commitments went “above and beyond“ what he had seen for other implanted devices.
He added: “This device has a 30-year history that is not so checkered, shall we say.“
“I think we still don’t have enough data about that group of patients that is showing signs of connective tissue disease,“ said panel member Amy Newberger, MD, a dermatologist from Scarsdale, New York. My concern is that hundreds of thousands of patients will have access to this and I felt approval was not warranted at this time.
Michael Choti, MD, panel chairman and associate professor with the department of surgical oncology at Johns Hopkins School of Medicine (Baltimore), said that though the recommendation was “perhaps unexpected,“ it reflected the “thoughtfulness“ of the panel.
“The decision was based on the evidence and data,“ Choti said. “I commend the panel.“
Dan Schultz, MD, director of the Center for Devices and Radiological Health (CDRH), called the two days of company presentation and panel review “an incredible high-level scientific discussion.“ He promised that CDRH would analyze both recommendations “in great detail,“ and said the hard work was just beginning for CDRH.
And while regulators are now left to sort out the panel’s decision making, Mentor and Inamed now have to proceed in very different ways.
“The testing that goes into these products is not . . . equal,“ Mentor President and CEO Josh Levine told reporters following the meeting. “I think the panel concluded that not all implants are created equally. We’re very gratified, but obviously there is still work to do because the FDA has not weighed in yet. If the science is what s focused on, we’ll get FDA approval.“
Levine said he was not concerned by the list of conditions required by the panel and that the company has been working with professional societies to prepare extended follow-up and device registries. “I don’t see the conditions as onerous,“ he said.
Not surprisingly, the decision left Inamed wondering what went wrong especially after what apparently went right for Mentor.
Dan Cohen, Inamed’s vice president of global government and corporate affairs, called the outcome “bizarre.“
“It’s inexplicable to me,“ he told Medical Device Daily. “I am surprised. Some panel members who were demanding longer-term data yesterday accepted shorter-term data today.“
Nicholas Teti, president and CEO of Inamed, called the vote “curious and inconsistent.“ “We look forward to working with Dr. [Lester] Crawford [the agency’s acting commissioner] and FDA staff on addressing these inconsistencies,“ he said in a statement.
Following the vote supporting Mentor on Wednesday, Diana Zuckerman, president of the National Center for Policy Research for Women and Families (Washington), called the panel’s contradictory recommendations “a triumph of wishful thinking“ over science.
As to the vote backing Mentor, she said: “Because of all the conditions, it’s far from a done deal regarding the FDA,“ she said. “It’s not helpful to women to have a product approved on the basis of two years of safety data.“