Mentor Application Gets FDA Advisory Panel Approval

Mentor’s application to sell silicone-gel breast implants was approved by an FDA advisory panel.

The panel that approved the application rejected it a day earlier.

“It’s a very illogical and conflicting message to the FDA, and a confusing message to women across the country who might have breast implants,” Diana Zuckerman, president of the National Research Center for Women and Families said.

According to a Forbes article,

“A major deciding factor for the panel was the rupture rate of implants from each company. However, the companies didn’t present data covering the same period. The statistics presented by Inamed looked at implants over three years; during that time, the rupture rate was highest in the third year. Mentor’s data covered only two years, and showed a much lower rupture rate.

Critics of implants have long contended that broken implants allow silicone to seep into a woman’s body, creating the potential for serious health problems.”

Mentor was very pleased with the panel’s approval.

WebProNews | Breaking eBusiness News
Your source for investigative ebusiness reporting and breaking news.