Ideas for Improving Study Follow-Up
In other testimony, panelists heard from plastic surgeons like Dennis Hammond, MD, of Cedar Rapids, Mich., who participated in the clinical trials of Mentor's Memory Gel implants.
In contrast to the 21% of patients retained overall by one of the Mentor studies, Hammond said he'd kept track of about 76% of the women he was following.
Panelists asked him how he did it.
"You've got to have dedicated surgeons that are really interested in making this study work," Hammond said. He said he had one staff member devoted to follow-up with women in the clinical trial and that he allocated about half a day of clinical time each week to seeing women in the study for follow-up visits.
Additionally, "A really compelling part would be if the patient had some sort of compensation. It doesn't have to be wild, really, just something they get back to compensate for the drive in."
Allergan, the maker of Natrelle implants, which had a 60% follow-up rate with patients after two years, said they paid women a small amount of money for filling out annual questionnaires and coming back to scheduled office visits. Mentor did not.
"While it was certainly admirable to try to get 40,000 patients [in each study] to come back, that just wasn't going to happen," Hammond said.
Perspective of Surgeons
The American Society of Plastic Surgeons (ASPS) agreed, and it urged the FDA to consider other data sources, besides the troubled studies, if the agency still felt the need for continued safety monitoring.
"There has been shown to be no relationship between silicone breast implants and connective tissue disorders, which was the main reason these studies were agreed to on the release of these products," said Phil Haeck, MD, president of the ASPS, in testimony to the panel. "This issue has been settled with the post-approval study data as it already stands now."
Haeck said sources like the FDA's own surveillance system, the Manufacture and User Facility Device Experience (MAUDE), which relies on clinicians to report instances of adverse events associated with devices, case reports, patient registries in the U.S. and Europe, and reviews of medical studies, could be relied on to spot any rare events that might arise.
Consumer advocates, like Dana Casciotti, PhD, the public health research director at the Cancer Prevention and Treatment Fund, said annual, 27-page questionnaires women were asked to complete should be shortened and simplified.
"I've seen copies of these questionnaires, and they are much too long" and technical, she said.
Panel members seemed to agree, and some suggested that future questionnaires might yield better data if they focused on symptoms rather than diagnosed diseases, since many connective tissue diseases, like lupus, are difficult to diagnose.