Silicone breast implants back on the market Serious health risks have not been addressed

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Imagine your playful, innocent seven year-old daughter examining her reflection in the mirror. Her expression is grim. She turns to you and inquires, “Do you think I need breast implants?”

Are you stunned into slack-jawed silence? Do you laugh at the ridiculousness of the question? Or do you pick up the phone, cancel your cable TV subscription and call Health Canada?

When a Toronto TV reporter shared this real-life anecdote with me last year, the federal body responsible for protecting Canadians’ health hadn’t yet ruled in favour of allowing silicone breast implants back on the market. This didn’t mean the devices weren’t available, but in order to access them, women had to sign a waiver acknowledging that they understood they were still experimental.

Last October, despite the ongoing questions about the implants’ safety, Health Canada announced it had granted licenses to two manufacturers that had been vigorously lobbying for approval for years. Shares of the companies shot up, and plastic surgeons celebrated.

Dr. Edward Melmed wasn’t one of them. Last week, the Texas-based surgeon confessed in US newspapers that over the course of several decades he had enlarged the breasts of “thousands” of women with silicone implants. But because of growing concerns he developed in response to the debilitating complications experienced by many implant patients, he now refuses to perform the surgery.

Instead, he has obliged almost a thousand women by removing implants that were causing them problems. In the process, he has documented a litany of complaints – rock hard breasts, disfigurement, joint and muscle pain, hair loss, chronic fatigue and depression – many of which cleared up when the implants were removed.

Health Canada doesn’t deny that such problems exist. In fact, the license it issued is a “Class IV”, the highest risk category for an approved medical device. And it comes with the requirement that the implant manufacturers conduct large, long-term studies involving tens of thousands of women to measure the potential connections between silicone implants and rheumatological symptoms, neurological disease, effects on lactation and offspring, and cancer and suicide rates.

You’re forgiven for thinking that this sounds like the kind of research that should have been required before the devices were approved. In fact, since the supposedly “new and improved” silicone implants have already been in use under a special access provision for many years, the manufacturers have had ample time to study their long term effects.

Yet some of the key studies submitted as evidence of silicone implants’ safety included women who have had the devices for fewer than three years. How predictive can such research possibly be when most cancers and auto-immune diseases take a decade or more to develop and be diagnosed? We would never permit a tobacco company to claim its cigarettes were safe by relying on data that tracked smokers for a similarly short period of time. 

The US Food and Drug Administration also approved silicone implants last fall. In recognition of the still troubling questions about rupture rates and the potential migration of silicone into women’s lymph nodes and organs, it recommended that all implanted women undergo regular MRI exams to monitor for breaks.

The $2,000 price tag on MRI screenings – not typically covered by private medical insurers – constitutes a significant cost for US patients. It may also explain why Canada, with its publicly-funded system, declined to require such a precaution. But we’ll end up paying for silicone breast implants in other ways, because studies in Canada and elsewhere have shown that implanted women use the health care system seven to 10 times more frequently than other women, and are hospitalized four times more often.

How many of these cautionary tales will women seeking implants receive from their plastic surgeons before they make the decision to go ahead? Health Canada has stipulated that the implant manufacturers must survey plastic surgeons and conduct focus groups with patients to ensure that their product labeling information clearly explains the risks involved.

But an investigative report produced by Radio Canada last spring found that three out of four Québec surgeons canvassed failed to fully disclose the risks or mention the special access status of silicone implants to prospective patients. And given the list of outstanding questions about the safety of implants, it remains debatable whether informed consent is even possible.

In the past year, additional concerns have been raised about dangerous levels of platinum in women’s breast milk, the deliberate suppression of evidence by implant manufacturers, and the results of a European study pointing to the potential link between implants and immune disease.

Are you worried yet?

The Toronto seven-year-old might outgrow her misplaced body concerns, but in some affluent North American communities, breast implants have become the grad gift of choice for 18-year-olds wanting to measure up to the dominant media image of ideal femininity.

From reality TV shows to consumer magazines, pop culture effectively positions breast implants as a mere fashion choice – more expensive than designer jeans, but longer lasting than Botox. The related risks – physical, emotional, financial – don’t generate a fraction of the attention earned by pneumatically enhanced pop stars and makeover features.

By sanctioning silicone breast implants, our health regulators are essentially medicalizing a dangerous fashion fad. In the process, they’re sending a disturbing message to Canadian women and men, boys and girls: they are apparently saying that small breasts are a health problem in such desperate need of treatment that other serious risks pale in comparison.

And that’s just wrong.

Shari Graydon is the author of In Your Face – The Culture of Beauty and You, and a member of the Canadian Women’s Health Network Expert Review and Advisory Committee. She has written a play about women’s relationship with their breasts called Normal.

An earlier version of this article first appeared in the Ottawa Citizen (01/10/07).

For more information on the health risks of breast implants, visit: www.cwhn.ca or contact: 1-888-818-9172.