Respected Women's Health Advocate and Industry Consultant Co-Author Measured Article on Informed Consent for Breast Implants
By Sybil Goldrich on December 19, 2007
The supplement to December’s Journal of the American Society of Plastic Surgery is all about breast implants. The editorial, “What Do Women Need to Know and When Do They Need to Know It?” is significant and important.
It’s significant because the co-authors make such strange bedfellows. Scott Spear, M.D., was the cheerleader for Mentor Corporation at the final FDA hearings where silicone breast implants were approved to return to the market. Susan Wood, PhD, quit her job at FDA because of the agency’s failure to deal with medication (RU486) in an unbiased and totally scientific way. Dr. Spear represents his colleagues in the plastic surgery world and his employers, breast implant manufacturers, very well, and Dr. Wood is a champion of women’s rights. Still, this "odd couple" wrote a measured article giving important information for both physicians and patients.
The article is important because, as Pam Noon-Saraceni says, “It goes into the details that are so often made light of in the consultations with the surgeons prior to a woman's decision to have breast implants.”
Here are the Beauty and the Breast blog, we strongly urge any woman concerned about women’s health to read it. It is hidden behind a subscription wall, though, so here’s our hopefully adequate summary:
What Do Women Need to Know and When Do They Need to Know It?
The article opens with a call for effective communications between doctors and patients. It says,
In this age of makeover television programs, enormous media attention regarding plastic surgery, high rates of long-term survival after mastectomy, and direct-to consumer advertising, it is especially important that physicians work to ensure patients understand the information, some of which is complex and not intuitive. What women learn from the World Wide Web, advertising, or word of mouth is quite often incorrect and misleading…. It falls on plastic surgeons as well as other physicians and trusted sources to provide this information.
Informed consent is critical, because getting breast implants is a life-long decision. The article points out, however, “the process of informed consent continues to be highly variable depending on who is giving and who is receiving and processing the information.” It emphasizes the fact that informed consent is complicated, because there is so much still unknown about this medical device, and “unknown risk is not necessarily the same as no risk.”
According to the article, this is what we know that should be made clear to breast implants candidates:
The article says, “As important as it is to advise women about what is known about silicone breast implants, it is perhaps more important to convey to them what is unknown.”
This is what we don’t know that should be made clear to breast implants candidates:
In the conclusion of the article, there is a concise synopsis of the critical issues around breast implant that need to be clearly understood and conveyed between patients and doctors:
Silicone breast implants… have been studied prospectively only for 3 to 5 years in the most recent studies submitted to the Food and Drug Administration. Women need to know and understand the known risks of rupture, capsular contraction, pain, and complications and the issues with mammography, as well as the likelihood of re-operation. Critically important is the need to understand that, as with all medical devices, these are not lifetime devices, and a small percentage of women will have ruptured implants within a few years. Therefore, proper follow-up to detect breakage will be necessary, and more than 15 percent should expect re-operations within 3 years. Women need to know that long-term studies with the newly approved devices have not been completed, and therefore, the expected lifetime and stability of implants are unknown at this time.
The article ends with the recommendation that after receiving information from their physician, from other health educators, and from written materials and other reputable sources, women take two weeks to consider this operation.
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