I’m sorry I couldn’t attend the Food and Drug Administration advisory committee meeting the past two days that learned the two manufacturers of silicone gel breast implants — Allergan and Mentor — failed miserably in enrolling sufficient women for the required follow-up studies of their safety.
According to MedPage Today, “Allergan has mustered only about a 60% follow-up rate after two years for its studies — far short of the goal of 93% — and only one in four patients who received a Mentor implant were followed up after two years.”
This will provide Allergan and Mentor with the proper incentives for gathering the requisite information for learning definitively whether there are serious health concerns associated with long-term use of silicone gel breast implants.
I’m sorry I wasn’t there because I would like to have heard the tenor of the questions coming from the outside advisors, and the FDA presentation.
What was the company’s excuse?
It turns out that both companies asked participants in the studies to complete 25-page questionnaires every year! No wonder most women said “no thanks.”
The advisory committee’s solution? Set up a registry, which will depend on plastic surgeons following their patients and reporting outcomes data.
Why should we think a voluntary reporting system that relies on the good will of hundreds if not thousands of surgeons, few of whom are reimbursed by insurance and most of whose clientele is more concerned about breast size than health, will be any more successful in collecting data than demanding that two companies collect the data? It seems to me the companies should be the ones required to set up a fool-proof system for conducting the required decade-long studies. And if they fail to enroll sufficient patients in such studies within the next two years, the devices should be pulled from the market.
Merrill Goozner is an award-winning journalist and author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs” who writes regularly at Gooznews.com.