Medical Device Daily Washington Editor
GAITHERSBURG, Maryland – Breast implant manufacturer Mentor (Santa Barbara, California) yesterday made an unexpectedly successful pitch to the same FDA advisory panel that sent Inamed (also Santa Barbara) packing on Tuesday with a vote against its silicone gel implant products.
By a 7-2 vote, the General and Plastic Surgery Devices Panel decided Mentor’s application was “approvable,” with several conditions, most of them very specific in nature.
The conditions include:
- Hands-on education sponsored by the company for board-certified plastic surgeons.
- Additional data collection.
- Independent data monitoring for ongoing studies.
- Development by Mentor of a patient education program and consent process.
- Modified case study to include patients who have had implants extracted and not reimplanted.
- Making the implants tracked devices by the FDA.
- Labeling recommendation for MRIs at five years to look for evident of silent rupture.
During its Wednesday discussions, the panel cited – as it did with Inamed – a lack of long-term study data and little information on the cause and impact of implant rupture.
Like Inamed, Mentor argued that its newest implants are better than versions from 20 or 30 years ago. According to FDA analysis released prior to the meeting, Mentor may have less long-term data than Inamed, particularly a lack of information concerning potential rupture. On Wed-nesday morning, however, company officers and researchers claimed they had more information about implant breakage.
The panel members seemed somewhat less inquisitive – asking fewer questions than they had of Inamed – but continued to focus on rupture and the need for longer-term data.
Josh Levine, Mentor president and CEO, provided FDA advisors with a polite reminder during his opening statement, asking for consideration “new and different from yesterday’s panel discussion.”
Panel chairman Michael Choti, MD, associate professor in the department of surgical oncology at the Johns Hopkins School of Medicine (Baltimore), asked the FDA for a comparison of Inamed and Mentor implants for the panel’s review. But the panel’s FDA advisor ruled that as inappropriate because one device is not considered based on the other’s data, and the companies’ premarket approval applications were filed separately.
According to company data, only 1% of implants ruptured during a three-year period in a Mentor study of about 400 women, with no reported cases of gel migration.
The FDA’s panel of analysts called the findings “limited” because patients weren’t tracked long enough following implant.
Responding to the panel’s obvious desire for tangible long-term data, company representatives said they predicted an implant lifespan upward of 25 years and included information from a European study with 12 years of follow-up data. Patients in that study had no ruptures until at least seven years following implantation.
Again, FDA analysts doubted the study’s use since it included only women choosing elective breast augmentation but no breast cancer patients or other high-risk populations.
Despite these doubts, more than one panelist called the company’s short-term data collection “excellent.”
“I think the sponsor has done the best job they could with the information that is available [regarding rupture],” said Joseph LoCicero III, MD, professor and chairman of the department of surgery at the University of South Alabama (Mobile).
Mentor also presented data showing that implants improve self-confidence for women following breast cancer surgery in addition to women who, for cosmetic reasons, want larger breasts.
Speaking for Mentor, Rebecca Anderson, PhD, an associate professor and psychologist at the Medical College of Wisconsin (Milwaukee), said quality-of-life considerations are as significant as other data. “I have treated thousands of patients,” she said. “My experience has convinced me that the benefits outweigh the risks.”
Levine promised aggressive post-market review following product approval for up to 10 years, and that the company traditionally had shown a “commitment” to such studies.
The panel, as it did on Tuesday, acknowledged that studies have found no connection between silicone implants and chronic diseases or that such illnesses can be transferred to a child during breastfeeding.