Safety Questions Linger continued...
Mentor implants showed a lower rupture rate, and a small, nine-year study of women in Britain helped convince experts to recommend approval under the condition that the company monitor women closely after surgery.
Inamed conducted a 2003 study of 250 women who got the implants for post-mastectomy reconstruction. But Friday's report complained that only a fraction of the women were studied using mammography to pick up small leakages that make up the vast majority of implant ruptures.
"There's practically nothing on breast cancer patients, and we think that's a terrible loss," Zuckerman says.
Last summer, the agency issued statements on "approvable" letters to implant makers Inamed Corp. and Mentor Corp. The letters require the companies to meet certain, undisclosed conditions before marketing is allowed.
Susan Wood, PhD, former director of the FDA's office of women's health, says companies have not studied the implants for longer time periods or in an adequate number of minority women.
"There is still such a lack of data in a very real and concrete way," she says. Wood resigned from the FDA in August to protest the agency's failure to approve the emergency contraceptive pill Plan B for over-the-counter use.
Inamed did not respond to calls seeking comment. In April, Patricia Walker, MD, the company's executive vice president for research and development, told the advisory panel, "Our data has shown no systemic illness, no connective tissue diseases over and above what you would expect in the general population."
In a statement, Mentor would not comment on the conditions FDA has laid out for its products' approval but says it "continues to work closely with the FDA to address the conditions outlined in the FDA's approvable letter."
"Mentor believes the advisory panel evaluated the data with rigor and made their recommendation of "approvable" based on the scientific merit of the studies included in the pre-market application," the company stated.
A 1999 Institute of Medicine study declared no connection between the implants and systemic diseases, though that same year former implant maker Dow Corning agreed to pay $3.2 billion to settle claims that its products sickened patients.
An FDA spokesperson says that the agency does not comment on pending product applications.