Wednesday, June 10, 2009

Women, Breasts, and the Failure of Informed Consent

This is the title of an editorial published in The Journal of the American Medical Women’s Association, JAMWA, in the fall of 2000. The first paragraph states the following: “Informed Consent is intended in part to level the playing field in the face of the discrepancies of knowledge, skill and experience between physician and patient.”

As a filmmaker working on my film Absolutely Safe, I meet and interviewed countless women that felt they weren’t given all the necessary information to make an informed decision when choosing breast implants, whether it be for reconstruction or augmentation. I still get calls from women that have seen the film or someone has told them about the film that have the same story. “I wasn’t told all the possible risks or complications.” In today’s information overload one has to wonder how that can be possible.

In this 2000 editorial from the JAMWA, the authors went on to write in the editorial “Advertisements promising “natural looking” and “voluptuous” figures that fail to highlight statistics on adverse outcomes, coupled with the plastic surgeon’s need to “sell” her services can render this informed consent process all but meaningless. Because of the tension between commerce and medicine, providers have an obligation not to just inform the patient/consumer but to affirmatively warn.”

In my experience with the issue of breast implant safety, many women have not been “affirmatively warned” of the possible risks and complications of breast implants. Nothing much has changed since this article was written in 2000. For mastectomy patients, according to a recent New York Times article entitled Some Hidden Choices in Breast Reconstruction, mastectomy patients are not being told of all their choices for breast reconstruction besides the use of breast implants.

Last week I discovered the existence of an Informed Consent Law for hysterectomies in the State of New York- Article 24-E, Section 2499. This comprehensive INFORMED CONSENT law on the books in New York State REQUIRES the Department of Health to publish a booklet on hysterectomy containing information about all treatment options. The booklet is mandated for distribution to every woman given the hysterectomy recommendation in the state of New York. This booklet outlines exactly what will happen during surgery, what will be removed, the after effects of the surgery, the potential outcomes, the potential dangers, the impact on the ovaries, hormone replacement therapy if the ovaries are removed as well as other possible treatment options. As a result, New York is a state with one of the lowest hysterectomy rates in the nation.

Why can’t we have this same type of law for the use of breast implants? Why shouldn’t every woman choosing breast implants be fully informed of all risks, possible complications and unknowns about the safety of breast implants? Why can’t women being faced with a mastectomy being given all the options to reconstruct her breasts?

To return to the editorial Women, Breasts, and the Failure of Informed Consent written in 2002. It ends with – “The original idea of the informed consent process presupposed a physician whose primary focus was the welfare and the best interest of the patient. Many physicians continue to adhere to these values, but some stand at the boundary between patient interest and market share.” Nine years later our breasts are still wrapped up in the market share.