I am not being reimbursed for addressing this panel. WIN ABC has received small grants from Mentor Corporation that total less than $20,000 over the 11-year period that WIN has existed, that in no way have influenced my position on this issue. Like many breast cancer advocates, I became involved in this issue following my own breast cancer challenges. Diagnosed in 1992, I underwent a mastectomy with immediate lattisimus dorsi reconstruction and a saline implant. This was unfortunate timing—just after the voluntary moratorium—so silicone gel implants were not very accessible. Last year, I underwent a revision of that reconstruction and the implant was exchanged with a tissue expander, which will later be replaced by a silicone implant to correct the poor aesthetic results including extreme wrinkling from the saline implant.

WIN ABC and I, personally, have helped scores of breast cancer patients, hearing many women state that they'd rather die than lose a breast to cancer. That fear keeps some women from even getting screened; for others, once diagnosed, it influences and delays treatment decisions that give them the best outcomes. When we let women know about their breast reconstruction options which can include skin sparing mastectomies, they are often able to reframe their attitudes and gain the fighting spirit so crucial to cancer survivorship and quality of life.

Quality of life is important for all patients -- for all people. No cancer treatment and no medical device are perfect. Panel members, with all due respect, I read FDA's memos that were made public prior to this meeting, and I am very disturbed about FDA's views on QOL. FDA seems to be questioning the benefits of breast implants. The benefits are self evident. The adjunct study was initiated in the interest of public health. Medicare and insurance pay for implants as a medical need.

Thus there is governmental recognition of a medical benefit. It is insulting to breast cancer survivors and other women to question the QOL benefits -- to question this when we are fighting so hard to keep access available for ourselves and our constituents.

It is offensive and disconcerting that FDA would suggest in its panel memo that some patients focus on appearance, while others are just relieved at recovering from cancer. If you or a loved one had testicular cancer and wanted a testicular implant, we would not judge you as being focused on appearance. If patients recover from cancer with a sense of wholeness, of feeling good about their bodies -- is that not meaningful? Is that not measurable? It is very meaningful to cancer patients.

Silicone breast implants, for a large sub-set of patients, are the best option to restore the natural look and feel of a breast following a mastectomy. We need to treat the whole person and make sure that patients’ medical and psychosocial needs are met; that they are empowered and informed to make treatment decisions based on good science and evidence-based medicine. We want to widen the treatment options for patients, not limit them. We want the public to be well-informed by good science, not bad hype that makes good headlines.

I can report first-hand that misinformation often results in creating tragic barriers to women and men seeking life saving breast cancer screening and treatment services.

I cannot count the times women have called our organization following a sound bite on the news about "the dangers of implants" or that FDA has "banned implants". Hype destroys hope. Misinformation leads to disintegration of health.

The recent headlines about rupture rates in the range of 90% are a case in point. Statistics such as this taken out of context are uninformative, misleading, and dangerous. The one 90% number from FDA’s memo to the panel was an exaggerated number based upon one particular method of projecting—essentially a worst-case scenario—and was also skewed because it included information on one particular type of implant that is not representative of others. The actual data submitted to FDA by the companies are more in line with published studies that estimate rupture rates at 15% at 10 years.

Also in the past week, a few organizations opposing SBIs continued to spread misinformation regarding silicone breast implants. Despite study after study reaffirming that there is no connection between breast implants and connective tissue disease or other long-term effects, these groups continue to raise this issue. These actions are a disservice to breast cancer patients and survivors and to all women.

Breast implants have been studied for decades and have been under intense scrutiny for a large portion of that time. The science is sound and ongoing. Every day, women seek breast cancer treatment options that include reconstruction with silicone gel implants, often their best reconstructive option, an option that can result in a new lease on life at a time when life seems so fragile and precarious, a choice that means hope, healing, and vitality to the all too many patients confronted with a breast cancer diagnosis.

Providing access only through clinical trials creates an unnecessary barrier and additional burden and stress in the lives of already challenged cancer patients.

It is my hope that your insight and wisdom will result in preserving the availability of silicone gel implants and the opportunity and right of women to make informed treatment decisions relying on sound science and evidence-based medicine and to choose whether or not to use them. Women make critical decisions every day of their lives – for their children, families, and themselves – please don’t underestimate our ability to make this decision, to handle this choice.

Thank you.

Last Updated: 04/14/2005

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