April 12, 2005
Risking women’s health
IT LOOKS as if two California manufacturers just won’t take no for an answer — even if women’s health is at stake.
In their third attempt, Santa Cruz-based Inamed Corp. and Mentor Corp., have submitted applications for FDA approval that would allow them to sell their silicone-gel breast implants to the general public.
The FDA began hearing from the companies and numerous women opposed to the approval on Monday, beginning a three-day public hearing on the issue.
If approved, the Food and Drug Administration would lift its ban, imposed in 1992, which limited the use of the implants to controlled research.
Lest the FDA and these manufacturers forget, there’s a reason the ban was imposed.
Numerous reports linked the implants to arthritis, vascular disease and a range of autoimmune disorders that followed after the implants ruptured.
“All the data indicates that rupture is inevitable,” said Diana Zuckerman, president of the National Research Center for Women & Families. “What have these companies shown to prove that it is now safe?”
In fact, in its preliminary analyses released last week, FDA scientists said the companies’ new reports, which only provide rupture data for two full years and partial data for a third year, is of “limited value” in gauging risk of ruptures.
While these manufacturers argue that their new product is made of a thicker liquid, preventing it from leaking into the body, there is little evidence to prove that.
It’s easy to understand why these companies keep coming back.
From 1997 through 2004, the number of breast-implant procedures performed annually has tripled, from about 101,000 to 334,000, according to the American Society for Aesthetic Plastic Surgery.
A green light from the FDA could mean big money.
But gambling on the outcome is a risk that neither the FDA nor these manufacturers should take.