Testimony of Marcy Gross at the FDA on the Lack of Breast Implant Studies

Marcy Gross, State of Maryland Women’s Health Promotion Council, April 2005.

I am Marcy Gross, a consultant who specializes in women’s health issues. I am a member of the State of Maryland Women’s Health Promotion Council and serve on the boards of various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women’s Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.

I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.

A legacy from my six-year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long-term gold standard study that will produce independent, objective research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.

The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short-term and are often produced by companies that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.

Third — and this is a change from the past — the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?

Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don’t know when.

I would assert that if this were an NIH-funded research study, it’s unlikely it would go forward.

Marcy Lynn Gross passed away unexpectedly on June 19, 2005. Marcy was an important national advocate for women’s health, and formerly a senior adviser with the U.S. Department of Health and Human Services. She worked closely with the National Research Center for Women & Families to prevent medically-unnecessary mastectomies. The Center is naming an internship in her honor.