FDA: Breast Implant Safety Studies Will Continue
Manufacturers fired back against the notion that they weren't doing enough to complete the studies.
"To imply that patient safety is not first on our radar is simply inaccurate," said Caroline Van Hove, a spokeswoman for Allergan. She said the company hoped that the meeting would give the FDA an opportunity to more fully appreciate the complexity of the required studies.
"In general, we are highly committed to collecting quality data in a way that is possible for them and possible for us," she said.
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.