Vancouver Courier
for July 15, 1998

The breast implant issue is controversial and highly emotional.

Recently I interviewed three victims - I can think of no appropriate synonym - and by the end I had tears in my eyes.

In fairness it must be said that women who have breast implants do so voluntarily. Whether the motive is breast reconstruction after surgery or simply enlargement for cosmetic reasons, no one's forced to undergo this procedure.

But, and I cannot make this point strongly enough, this is utterly irrelevant. The motive for a surgical procedure had nothing to do with the obligation on the surgeon to properly warn patients of the possible consequences.

There is a second underpinning to my argument. We're not talking tummy tucks, liposuction or face lifts here though the principles of safety and risk assessment apply to them as well. We're talking about a woman's breasts. I should hardly have to say more than that.

Now in this process there are four main parties.

There is, of course, the patient who comes to the operation with huge emotional overlays. Whether it's breast reconstruction or cosmetic surgery, this is special. Very special.

There is the doctor who makes about $6,000 per operation though as Dr Kimit Rai President of the Canadian Association of Plastic Surgeons told me, if they screw up, the second operation is on the house.

There is the manufacturer whose business it is to sell the devices necessary and for whom concerns for the health of the patient is at no higher level than the desire of the car manufacturer to keep new customers coming in. And unlike the car company, the implant maker doesn't really have to worry about "lemons" until many years later.

And there's the government.

Let's deal with the last first. Plastic surgeons would have you believe that the devices have been approved by the Food and Drug Association in the States and the Health Protection Branch in Canada. They haven't. What happened is that when "implant" legislation came in back in 1976 breast implants were "grandfathered" because they were in such widespread use. The FDA, in fact, has been warning about serious consequences of implants for some years including a stern warning in 1995.

Studies have been spasmodic and mostly done by or on behalf of plastic surgeons which is like asking the plumber to rule on whether a complicated metropolitan sewage system is safe. Like the plumber, the surgeon has a huge stake in the answer being "yes."

The other "research" done is by the manufacturers themselves which is akin to the safety of tobacco being assessed by the cigaret industry.

What are patients told when having their case assessed by plastic surgeons?

Unlike the General Practitioner who wants to avoid risk to his/her patient, the surgeon has a $6000 reason for the risk to be taken. (Spare me the arguments about the Hippocratic oath and all that gup - we're talking about a businessman with some special letters after his name.)

According to Dr Rai, the plastic surgeon carefully assesses the risks with the patient. Does he now?

Not according to what I've been able to glean. It seems common ground that he does give the usual warnings about surgery in general but the FDA warnings are certainly not given and the frequency and consequences of failure if mentioned at all, are minimized. (The stated failure rate is about 10%. According to Dr Pierre Blais, a former government scientist and now an adviser on these matters it's many times higher. The 10% figure, says Dr Blais, is only those women who in desperation submit to a subsequent operation.) The patient is given pamphlets, conveniently put out by the major stakeholders in the business, the surgeons and the manufacturers. They're certainly not told that they will probably need replacement operations in 6-10 years. What you can be absolutely certain of is that none of them are given the readily available warnings of Dr Blais and others.

The opinions and writings of Dr Blais are sobering to say the least. Putting foreign objects in the body carries in itself serious ramifications. Putting a plastic case full of salt water inside a women's breasts carries special concerns. Dr Blais likens it to a swimming pool that can never be cleaned. Chemical changes occur to both the saline solution and the casing. That's because chemical changes take place to everything.

And the problems are by no means only physical nor just confined to the woman. She may well lose all sensation in her nipples. Her intimate relationships may deteriorate.

All of these things may not happen too. Many women are quite satisfied with their operations.

The point is a simple one. These operations are not certified as safe by government, they have for many women very serious physical and emotional consequences and, for the most part, the people helping the patient assess the risk are those who stand to make huge profits from a positive decision.