Respected Women's Health Advocate and Industry Consultant Co-Author Measured Article on Informed Consent for Breast Implants

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:

  • Women getting breast implants are likely to have one or more re-operations on her breasts, some within just a few years.
  • Two studies concluded that only 30 percent of plastic surgeons familiar with a patient and her breast implants detected a silicone gel rupture, compared with 89 percent detection with magnetic resonance imaging. MRIs are the most accurate way of detecting rupture, which are usually silent, may have consequences, and when detected, usually leads to removal of the implants to prevent migration of silicone into the patient’s adjacent tissues.
  • All breast implants, whether silicone or saline, interfere with mammograms, and the larger the implants, the more likely they are to obscure some of the breast and potentially hide cancerous tumors. Extra radiographic views of the breast require a specially trained technician and cost more, take more time, and expose the woman to more radiation. Mammography may also lead to rupture, especially if the implants are older.
  • Breast implants may eventually feel hard and become painful (i.e., capsular contracture), and this is not uncommon. Along with this, the breasts may look abnormal. Since many women seek implants for reasons associated with appearance, that capsular contracture is the most common cause of re-operation and implant removal is a critical fact to convey.
  • Women are likely to feel better about the appearance of their breasts in the years right after getting breast implants, but implants do not address underlying psychological issues, like improving self-esteem or body dysmorphic disorder. There are no long-term data on the effect of breast implants for improvement of overall body image.
  • If an implant is ruptured and if the gel has migrated outside the capsule, removal can be difficult. Silicone leakage into the tissue may result in removal of breast tissue, so that even with replacement, women’s breasts may not be fully restored.
  • After a second surgery, the risk of more complications, especially capsular contracture and rupture, is higher than before. Revisions or secondary corrections do not reduce the need or likelihood of future surgery.
  • Breast implants for augmentation, and additional treatment, are not usually covered by health insurance. Insurance companies may drop coverage or raise premiums for women who have undergone breast implant surgery.
  • 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:

  • The studies carried out on the newly approved products provide little information after 3 to 4 years for an implant that is expected to be in the body much longer than that. And with each new product that comes on the market with claims of being new and improved, the comparisons once again will be based on short-term studies. Women need to know that we do not know how long implants last.
  • We do not have good long-term data on outcomes for women undergoing reconstruction after breast cancer surgery. Women with breast cancer are known to have higher risks of complications.
  • Women with breast cancer need to know all of the surgical and non-surgical options after breast cancer surgery, and not be left with the misconception that surgical reconstruction is actually a necessary part of their cancer treatment.
  • We do not have specific data collected and analyzed on women of different races and ethnicities. Differences in keloid formation, scarring, capsular contracture, and other complications in African- American women are a potential problem that has not been studied in breast implants and thus remains an unknown.
  • Many studies to date have failed to identify a statistically significant increased risk of classic autoimmune diseases, except in some limited forms (the possible increased risk of fibromyalgia with extracapsular silicone and other potential autoimmune symptoms). But women with autoimmune disease or a weakened immune system were excluded from the clinical studies for these products. They also included very few African-American or Hispanic women, who are at higher risk for lupus and other autoimmune diseases than non-Hispanic white women are.
  • Regarding cancer, there is compelling evidence that breast implants do not increase the risk of breast cancer, but it is also known that breast implants may obscure the mammographic detection of breast cancer by reducing the sensitivity of mammography.
  • The increased risk of suicide among women with breast implants was statistically significant in several large studies. With the increased rate of women with body dysmorphic disorder who seek breast implants and other plastic surgery, and the fact that implants will not improve this condition nor raise overall self-esteem, it is possible that mental health problems predate implants in some patients.
  • Young women who may decide to have children in the future need to know about the possibility of reduced success in breastfeeding and about the need for research on possible leakage of silicone or other implant substances into breast milk, as this remains an unanswered question.
  • 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.

    For other information about breast implant safety, please visit the FDA's breast implant website, and also the website of the National Research Center for Women and Families.

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