Testimony of Marcy Gross during the Public Comment of the FDA Advisory
Panel for Silicone Gel Breast Implants in April 2005.

http://www.breastimplantinfo.o­rg/what_know/mg_fda_test_apr05­.html

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.

~~~~~~~~~~~~~~~

www.BreastImplantInfo.org

www.BreastImplantAwareness.org­#Action
You can sign Petition on Mentor implants