Myrl Jeffcoat myrlj@jps.net

MS. GREEN: I'm Bettye Green. I'm the President of African American Women in Touch. And I am a breast cancer survivor. And I chose reconstruction after a mastectomy. However, I believe breast cancer patients deserve more information than they are getting.

Fortunately, there are many more options than there used to be for breast cancer patients. More than three out of four are eligible for lumpectomy. So relatively few women with breast cancer have a need to undergo a mastectomy in the last few years or in the coming years.

And, fortunately, women who undergo mastectomies have two other alternates to silicone breast implants. They can choose saline breast implants, which have a lower complication rate and are easier to remove when they break, or they can choose an autologous tissue transfer, a very popular procedure that moves tissue, in fact, from the abdomen or other areas to create a breast that is much more natural looking and feeling than a breast implant

reconstruction.

Over the years, FDA panels have heard from some breast cancer survivors about the mental health benefits of silicone breast implants for mastectomy patients who want to reconstruct their breasts, but now that there are so

many choices, do silicone breast implants offer benefits that are greater than other options, so great that they are more important than safety?

Research by Dr. Julia Roland of the National Cancer Institute and her colleagues found no difference in the quality of life of women who underwent lumpectomies, women who underwent mastectomies, and women who have had mastectomies with reconstruction.

Even more surprisingly, the women who had reconstruction felt their sex lives had been harmed more than mastectomy patients. If we look at the data presented by Inamed and Mentor, these findings make sense.

Most reconstruction patients require a lot of complications. They report more autoimmune symptoms two years after implants, such as joint pain and mental confusion, compared to before getting breast implants.

According to a study of women who had reconstruction five years earlier, most implant patients were no longer satisfied. In contrast, most of these autologous tissue transfer reconstruction patients remain satisfied. The implant makers remind us that their studies show that patients are satisfied.

But as a cancer survivor, a nurse, and a leader of a national group for breast cancer patients, I can tell you that most breast cancer patients don't tell their plastic surgeons that they are unhappy. They have been through cancer. Most don't like to complain about how they look now, especially in a study when being honest will not help them in any way and could potentially harm their relationship with their doctor.

I have another concern that nobody has mentioned and that is very important. There are very few African American women or Asian American women in the Inamed or in the Mentor study. For example, there are only six African American breast cancer patients in the Inamed core study and only five Asian American women.

This is a big problem because African American and Asian women are more likely to develop a cheloid scarring. This scarring tendency could potentially increase the risk of capsular contracture as well.

African Americans are also at an increased risk of autoimmune diseases. So it is essential that silicone gel breast implants not be approved until they are carefully studied on women of color.

In summary, research suggests that women who have had reconstruction after mastectomy do not have a higher quality of life than women who do not undergo mastectomy. Their sex lives seem to suffer more, not less.

Independent researchers found that the majority of implant reconstruction patients are not satisfied five years later. These findings are more credible than those funded by implant companies.

In one study, reconstruction patients were ten times as likely to commit suicide as mastectomy patients who do not undergo reconstruction. More African American and Asian American women need to be included in breast implant study, especially studies of breast cancer patients. Neither Inamed nor Mentor have studied enough women of color to determine if the risks are any different for them compared to white women.

Thank you so much for listening.