Implant scandal underlines ethical issues

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Venezuelan women affected by PIP implants demand distributors cover expenses.

The faulty breast implants made by the French company Poly Implants Protheses, or PIP, have grabbed headlines around the world in recent weeks, and it's no wonder. The prostheses are more prone to rupture than other models, and they contain an industrial grade of silicone never intended for use in a medical device.

The scandal is also global. Sold in 65 countries, the implants were rebranded by a Dutch company registered in Cyprus, offered on credit in Venezuela and smuggled into Bolivia, where they were bought by medical tourists.

There has been a surprising lack of agreement about the safety of the implants. In France, women were advised to have them removed -- at public expense. But British health officials blandly stated there was a "lack of evidence" linking PIP implants to cancer.

That 300,000 women around the world received the implants seems at first glance to be a spectacular example of medical malfeasance and regulatory ineptitude. But the scandal also raises a more basic question: Are the risks of any esthetic surgery acceptable?

Calculating health risks is especially difficult with esthetic procedures. With most surgeries, the risks are weighed against expected health improvements. But esthetic procedures, by definition, do not improve health. For this reason, 19th-century plastic surgeons limited themselves to reconstructive procedures in a bid for medical acceptance. Today, cosmetic plastic surgeries outnumber reconstructive ones in many countries.

Yet the same ethical concerns that early plastic surgeons had with performing esthetic procedures have never been resolved.

Some patients may overlook the risks of esthetic surgery because it is performed by doctors. The ritual elements of medicine -- the white coats, the bedside manner -- powerfully symbolize health. The fact that a surgeon is putting in implants sends a subtle message that they are safe. What healer would do something to harm us?

One response to the PIP scandal would be a ban on doctors performing cosmetic breast augmentation altogether. It's well known that breast implants of many types can cause burning pain, loss of sensation, hardening of breast tissue and serious infection.

An argument could be made that esthetic surgery violates the Hippocratic oath because it carries a potential for harm without curing disease.

But banning cosmetic surgeries would be difficult to enforce internationally. More than half a million U.S. residents alone went abroad last year for medical care, and elective treatments such as cosmetic surgery are the most popular treatments.

Though the PIP implants were not authorized for use in the United States, they were sold to American medical tourists in countries such as Brazil.

More important, esthetic surgeries and procedures have become an established part of medical practice. They are no longer just the domain of plastic surgeons and dermatologists but are increasingly performed by GPs, ob-gyns, endocrinologists and other medical specialists, a trend known as "practice drift."

And the sheer availability of a procedure can make it appear necessary. Cosmetic dentistry is so common it is not always thought of as "cosmetic." Some plastic surgeries similarly lie in a grey zone between necessity and medical enhancement. For example, breast reduction is seen by many as medically justifiable. But in Brazil, the operation often has mainly a cosmetic aim (small breasts are an erotic ideal, while larger breasts are seen as matronly).

Reconstructive surgeries such as breast implants following a mastectomy also concern esthetics. As with cosmetic augmentation, the goal is not to improve function but appearance.

Breast cancer patients are usually seen as medically entitled to implants.

Still, classifying breast implants as reconstructive does not mean they are less risky. At least a fifth of the French women with PIP implants received them after mastectomies.

Calculating risks with any form of plastic surgery is difficult because it depends on weighing potential harm to the body against improvements to intangible qualities such as sexual and psychological well-being.

Perhaps the latest implant scandal is just a misstep on the path to greater safety in esthetic surgeries.

In 2006, the U.S. Food and Drug Administration ended a 14-year moratorium on silicone implants with the approval of two new models. Shortly after, breast augmentation became the most commonly performed cosmetic surgery in the U.S.

But while medical advances can result in safer cosmetic procedures, they can also contribute to their normalization. Yesterday's vanity is often today's health, or at least well-being. As beauty becomes a more visible part of medicine, health risks may become less visible. And that is a big risk.

Alexander Edmonds is assistant professor of anthropology at the University of Amsterdam and author of Pretty Modern: Beauty, Sex and Plastic Surgery in Brazil.

--The Los Angels Times

Republished from the Winnipeg Free Press print edition January 10, 2012 A10