Testimony of Anne Kasper, PhD at the FDA on Silicone Gel Breast Implants

Anne Kasper, PhD, Finding My Way, October 14, 2003

My name is Dr. Anne Kasper and I am a partner in Finding My Way, a support service for breast cancer patients in Bethesda, Maryland. I am also the senior editor and author of the book Breast Cancer: Society Shapes an Epidemic.

Breast cancer patients have more choices than ever before. While it’s important to have choices, when a woman is diagnosed with breast cancer, the choices can be difficult to make.

• Three out of four women newly diagnosed with breast cancer can choose to have a lumpectomy with radiation instead of mastectomy.

• If a woman needs or wants a mastectomy, she can choose saline breast implants, silicone gel implants, or autologous tissue transfer procedures.

How important is it that silicone gel breast implants be widely available to cancer patients? Under the current restrictions, the vast majority of women who want silicone gel implants for reconstruction are able to get them.

But, breast cancer patients tend to be cautious. They want to live long lives. However, they also are concerned about cosmesis and how they will look after cancer treatment. Many will choose lumpectomy, which allows them to keep their breasts, preserving their appearance and the sensory feelings of the breasts. Women tell us that they only want silicone gel implants if they can be assured that they are safe. Women are often encouraged to choose implants and a rosy picture is painted about the benefits of implant reconstruction. However, in our practice women are often disappointed to have reconstructed breasts that have none of the sensory, sexual, and maternal capacities of a normal breasts and that often have complications.

Many reconstruction patients who choose silicone gel implants are happy with their implants at first. Unfortunately, many women experience the kinds of complications that Inamed found, such as:

46% will need additional surgery within 2 or 3 years
25% will have their implants removed within 2 or 3 years
6% will have a ruptured implant
6% will have moderate to severe breast pain
6% will suffer from necrosis, a complication in which their skin or breast tissue dies and the wound takes a long time to heal

In the Inamed core study of breast cancer patients, only 6% of the implants broke during the first 2 or 3 years, but over time we know that percentage increases. This is much more serious than when a saline implant breaks. When silicone gel implants break, the silicone can leak into the lungs, lymph nodes, and other organs. To determine the safety of silicone gel implants, Inamed should have studied the health of women whose implants broke — especially since cancer patients have compromised immune systems. Unfortunately, they did not.

Another shortcoming of the Inamed research is that it included only 6 African American breast cancer patients in the core study and only 5 Asian American women. Obviously, this is not appropriate data on which the FDA could make a safety decision for all American women. Both groups have approximately the same rates of cancer as white women, and African American women are especially susceptible to autoimmune disease. These women must be studied to determine if implants are safe for them.

The bottom line, though, is that the complication rates for breast cancer patients are very high in just the first two or three years. What will these women’s lives be like in the next 5 or 10 or even 20 years? Most breast cancer patients are living long lives. Many choose mastectomy as a way to “get it over with” and “put cancer behind them.” With re-operation rates of 46% in the first two or three years, and higher rupture rates in the years to come, many women will not consider implants a satisfactory and safe choice at all.

It is unusual to ask for more than 2 years of safety data for a new product, but silicone gel breast implants are not new. Inamed is asking for approval for an implant that has not changed much if at all in more than a dozen years. If FDA had strictly enforced their restrictions on breast implants, which were established in 1992, we would have 10-year data by now, instead of 2-3 years.

If the FDA approves silicone gel implants based on the data provided, it sends the message that they are not as concerned as women have a right to expect about the health and safety of breast cancer patients, and especially women of color.

If the FDA allows silicone gel implants to remain on the market, but only as part of clinical trials, and this time requires a third party to monitor the studies, then perhaps breast cancer patients will finally get the information they need to make a meaningful choice.