FDA: Breast Implant Safety Studies Will Continue
Perspective of Surgeons continued...
"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.
Patients who took time off work and paid their way to testify at the meeting urged the FDA to keep trying to answer questions about the long-term and rare complications of breast implants.
"Not everyone gets sick, but those who do, we pay dearly," said Sharon Schwengler of Phoenix.