I could rattle off a million reasons why women should not get breast implants. But at the top of my list, and what I have spent my life working on, is the issue of informed consent – a patient fully understanding the risks of this cosmetic surgery before going under the knife. Of course, in my biased opinion, anyone who chooses to undergo breast augmentation clearly does not have a good understanding of what could happen or they wouldn’t do it! But there are very real obstacles in the way of women getting all the necessary information and being able to conduct a good risk assessment, some of which I would like to lay out here:

No one really knows how long implants actually last and what their long-term effects could be.

Breast implants are indeed one of the most researched medical devices, but the research (predominantly paid for by implant manufacturers) has been “front-loaded.” Almost all the safety data collected thus far has been from women who had implants for a relatively short time, less than five years. Implant recipients, however, keep these devices in their bodies for decades. In a recent New York Times article, Dr. Stephen Li, who has served on three of the FDA’s panels that reviewed implant safety, acknowledged that silicone implants are “a device that you have only three or four years of data for,” and admitted that “we don’t know specifically how long implants last.”

There still critical work to be done in looking at the long-term health risks of breast implants. The absence of research in the longer time frame, however, is a fact not widely known or understood, even among plastic surgeons. How, then, can it be conveyed to women?

The FDA’s approval of breast implants is commonly but falsely taken to be a guarantee of safety.

According to the mission statement published in its new Strategic Action Plan, “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” This statement is consistent with what the public believes the FDA actually does, so when silicone implants went back on the market in 2006 after a 14-year moratorium, the FDA decision was publicly understood to be a safety endorsement.

But what the FDA tries to do and what it actually does are two different things. With millions of dollars at stake in every FDA regulatory decision, industries work hard to influence the regulatory process, and as a result, the agency is subject to political pressure and vulnerable to making decisions not always based on science.

This is certainly the case with breast implants. In 2003, Dr. David Feigal, head of the FDA’s Center for Devices and Radiological Health, admitted as much when he said that people have the misconception that an FDA-approved product is safe, but, actually, the agency evaluates products to see if risks outweigh benefits and then it’s up to “the consumer to decide whether or not they’re willing to take those risks.”

If the FDA doesn’t guarantee the safety of breast implants, plastic surgeons certainly shouldn’t, yet so often they make those reassuring noises that make it seem like they do.

The marketing around breast implants – including information imparted by medical facilities – is often misleading and sometimes just plain false.

Which?, a consumer protection organization in England, recently released the results of an undercover campaign to assess the marketing practices of the English cosmetic industry. It found questionable marketing tactics such as pressure selling (use of discounts, deadlines and ‘bogofs’ or buy-one-get-one-free), non-medical staff giving inappropriate or inaccurate information, and misleading or inaccurate claims about results. It found lack of detail in possible complications and risks, and doctors unacceptably vague about their qualifications. Regarding breast implants, only two of the six breast augmentation visits met or largely met the criteria for acceptable standard of consultation, and only one breast augmentation clinic largely met the criteria for acceptable standard of practice.

I am confident that a similar campaign here in the United States would yield the same if not worse outcomes. Why else would the Los Angeles Times’ Cosmetic Surgery and Information Center have published a booklet about the cosmetic surgery industry called, Warnings and Red Caution Flags? A blurb about the booklet on the CSIC site says:

Find out about the 8 major warnings and red flags about having cosmetic surgery, including:

* Misleading statements about board certifications
* Deceptive and False Advertising
* Cheap “low ball pricing” by surgeons
* Having surgery out of state or in a foreign country
* Surgery Mills
* Plus much more!

But here’s one clear example of misleading marketing. Recently, this press release was brought to my attention. The release is titled, “Indiana Plastic Surgeon Dr. Robert Frank becomes certified to offer Silicone Breast Implants for Breast Augmentation by Allergan and Mentor,” implying that manufacturer certification somehow makes getting implants from Dr. Frank safer than getting them from other doctors. In fact, all doctors who offer silicone implants are certified (and it seems online certification is possible) because it’s a requirement for access to silicone implants. The body of the release is devoted to how qualified Dr. Frank is, and then how research has proven once and for all the safety of silicone implants. One sentence says, “With the recent approval of silicone gel-filled breast implants for breast augmentation and breast reconstruction, physicians and patients can be assured of the safety of silicone.” This is nothing less than the false marketing of safety and it unfortunately pervades the plastic surgery industry.

The examples I offer here are just a few of the roadblocks in the way of women being able to give truly informed consent when they get breast implants. From images of implanted women saturating the media to the popularity of programs like Dr. 91210, from misconceptions about medical device legislation and safety to the quality of information imparted to patients or potential patients by medical facilities and practitioners, women are systematically discouraged from getting all the information and taking seriously the very real risks associated with breast augmentation. The false impression of safety has suffused our society. The cultural cues are too loud, the business dynamics of the cosmetic industry too strong, and the data needed to drive home the risks not yet collected. In the face of all this, the fact that breast augmentation is an unnecessary but major invasive medical procedure seems to have been overwhelmed and lost. If this is true, when a woman gives consent for breast implants, is it ever possible for her to be truly informed?

TAGS: breast implants, plastic surgery, FDA, women’s health, informed consent