Statement by Marcy L. Gross

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 14, 2003

Good morning.

I am Marcy Gross, a health policy consultant and member of the State of Maryland's Women's Health Promotion Council.

I retired last November after 25 plus years at HHS, most recently in the position of Senior Advisor for Women's Health at the Agency for Healthcare Research and Quality (AHRQ). During part of my tenure at HHS, I also participated in the former Secretary's ad hoc Working Group on Silicone Breast Implants.

I give you this brief resume to establish my familiarity with the issues you have under consideration today, but am here speaking entirely as a private citizen, and base my remarks on my own personal views and on information available to the general public.

One legacy of my 6 year tenure at AHRQ is a good appreciation of the need for women and policy makers to have a strong evidence base for making decisions on health care issues. My concern today is that an adequate evidence base for the premarket approval of silicone gel-filled breast prostheses does not exist, and that the short-term assurances drawn from the applicant's study will override acknowledgment of the troubling gaps in research on long-term risks.

I can see from the information posted on the panel's web site for the hearing that FDA's background work has been exhaustive, encompassing extensive literature and statistical reviews, assessment of the toxicology and chemical testing, and extensive consideration of clinical data. All this data and more will come to you again over the next two days.

But, the basic facts are simple, and have not varied in the 12 plus years since silicone implants were pulled from the market:

1. The studies available on the health aspects of silicone gel implants are short-term analyses, often involving mere handfuls of mice studied over the course of a few weeks in the case of toxicology and chemical testing; and, in the case of Inamed's Core Study, involving patients studied over a two-three year period.

2. Yet, even these short term assessments indicate that the rate of ruptures and other complications which lead to re-operations remains high, unacceptably high in my view: 20 percent plus for patients using implants to augment their figure, and 45 percent plus for reconstruction patients.

Thanks to our longer life span, breast implants will stay in a woman's body for the rest of her life, which can be 50 years or more, or so many women are told. Even when it is acknowledged that they will have to be replaced, women are given a time line of 10 to 20 years. Thus, a two-three year study simply doesn't offer the kind of assurance of safety needed to understand the health implications of accepting an implant. It is a set-up for future medical problems for the women who have this type of device implanted, especially when retrospective studies show that by 10 years, most women with silicone gel implants will experience at least one broken implant. At least these women know they have a problem and seek further surgery: Silent ruptures are also a documented and recurring problem.

Sometime in the next few days, I feel certain that you will hear someone say that none of the several important studies of possible health risks of implants has shown that they cause a health problem. You may even hear it said that, well, we use silicone in many other implanted devices such as heart valves, knee joints, etc, so why should silicone from breast implants be different?

My response is that having bubbles or globules of migrating gel floating through a human body, into and around organs, is, on its face, a health risk. As for the silicone in other implanted devices: one doesn't expect bits of a heart valve to break off and migrate to a patient's brain, liver, or other organs. Further, patients who get knee or hip joint replacements are routinely warned that a small number of patients will have an immune system reaction to silicone fragments shed by newly implanted joints.

There is no health imperative behind the push to reintroduce silicone breast implants. On the contrary, they are used in an elective, cosmetic procedure that often causes serious health complications associated with ruptures and the surgery itself. Although there are other options available to breast cancer patients that carry fewer risks, for some, access to silicone gel implants is felt as important to their recovery. We know that this will make them more vulnerable to future illness and complications and will obscure future cancer screening procedures. But, again, we lack the kind of long-term studies that would allow their choice to be fully informed.

This FDA panel will be making a decision that affects the lives and pocketbooks of women involved quite substantially. There are substantial, emotional issues involved in the decision and results. Implants are also an expensive procedure, especially when the cost of care for complications, re-operations, infections and other medical side affects are added in. Some 225,000 to 250,000 new procedures were done last year. If costs of surgery are estimated as $5,000 each, the total cost approximates $1.2 billion dollars. While much of this is paid for by the patient, the cost for reconstructive procedures after cancer surgery is most often covered by insurance, as are some of the costs for any follow-up treatments needed.

What is the policy recommendation here? FDA found the middle ground 12 years ago. And while I would still prefer not to see the 4-fold increase in implants that has since occurred, at least the current policy sends a strong cautionary signal to women with choices. That should not change until we are more confident that these implants are safe for long-term use. That will take more time and more research, the kind of research that should have been initiated 10 years ago.

I thank you for your time and attention this morning. I see that your agenda runs well into the evening, and I wish you luck--and stamina.


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. For more information about Marcy's national contributions to women's health, click here.