The committee was to determine whether long-term safety data supported the use of these devices, which hit the U.S. market prior to the passage of laws permitting the FDA to regulate medical devices. They decided that the withdrawal of at least this device was not merited if patients understood the risks.
"I found the whole issue of safety and efficacy very uncomfortable," said Karen Bandeen-Roche, PhD, a member of the FDA advisory committee. "Then I decided that the best solution is not for me to decide," she said, reflecting the committee's overall opinion.
But data presented at the meeting showed that the use of these devices, or at least those made by Mentor Corp., did incorporate a fair share of risks. About 73% of patients receiving implants for breast reconstruction after cancer and 43% of patients electing to have implants for cosmetic reasons experienced complications, when incorporating symptoms such as numbing of the nipples. And about 40% of the reconstruction patients and 13% of the cosmetic patients also had to undergo a secondary operation to remove or replace the implants within three years, primarily due to complications such as capsular contraction.
Nancy Dubler, LLB, an expert in bioethics, was the sole member of the FDA committee to vote against giving the Mentor devices the FDA's stamp of approval. "Given the deflation rate and leakage rate ... I just couldn't vote for approval," she said.
Susan Kolb, MD, a plastic surgeon who also has saline implants, sums up the reigning mood of the meeting: "I don't know the true dangers of saline. I'm my own experiment on that."