Should Breast Implants Be Allowed Back on the Market?

The following are comments from Suzanne Parisian, M.D. from Arizona, provided to Ms. Isabelle Maher Journal of Montreal about the status of Health Canada's licensing of silicone breast implants.

My concerns are that young women receiving silicone breast implants are being used as guinea pigs in one big giant clinical trial without receiving adequate informed consent.
Unfortunately, the science and performance information to know whether these products are "safe" should have been obtained over the period that they were off the market. It was not.

The 2 firms did not want to obtain that information, many physicians did not want to obtain that information, the government grew tired of trying to fight to get the information. Both firms have essentially managed "to survive" until they were allowed back on the market.

The government grew poorer and more importantly the public became "bored" with the issue and bored with the women involved.

In a sense, the last two firms "standing" won the prize - the market.

There are so many unresolved questions that now will not be resolved.

An entire generation of young women do not know or remember the prior concerns about breast implants in the 1990s and the patients that had their lives destroyed by them.
They see the products used on TV and by the movie stars - and now the government licensing/ approval and that makes them think that they are "safe" devices. They want to believe they are SAFE.

I am sad to think of young women obtaining silicone breast implants - the risks are still "unknown".

To me the real question is why was the "science" about these silicone-containing products "NEVER developed"?
Why was "female health" in terms of these products just not considered important enough?

At regulatory conferences I attended there was very little discussion about the science of silicone.

Why did no one ever do the type of studies everyone just "assumes" were done?

For example, no one ever looked at the genetics to see if there were certain groups of women at increased risk for bad reactions or immunological stimulation by silicone than other women.

Could methods have been developed to allow some sort of pre-screening - before a woman receives a silicone implant? Find out which women were at increased risk for a bad outcome?

At regulatory meetings- why was there such a gulf between the women with good results and the women with bad results? No one ever looked closely at the 2 populations of women to explain the differences.

Why are litigation databases of women with bad outcomes not being used as a scientific study population to look for explanations as to why they had such bad results? All that human data - and no one is looking at it? That does not make sense.

Why are studies not done to look at the children born to women with breast implants?

Perhaps in Canada, such studies could be done.
Again, are there some children that have an immunological predisposition to a bad result from exposure to silicone compared to other children?

How will women in Canada pay for the additional screening required for breast implant rupture?

Why did the same two manufacturers say publicly their devices would last 5 years in the United States at the FDA Panel meeting and 40 years to Health Canada? How can that be possible for the same devices?

Why is MRI screening recommended in the USA at the FDA Panel meeting - and removal of ruptured implants and not at Health Canada?

Why was it never mentioned at FDA or Health Canada that breast MRI is not a standardized process - and the 2 firms used centers with an experienced radiologist to interpret breast MRI for rupture. This is not a procedure that is commonly available in the USA or Canada.

Why do health insurers in the USA not want to insure women with silicone breast implants?

It is one of these little and important "unanswered" questions that will come back to eventually haunt us in the future years - perhaps when the public is no longer "bored" with the issue.
Unfortunately, a proportion of the young women happily receiving silicone implants today will be part of that future search for answers.

Breast implants are "cosmetic" devices - and the unknown risks - most of which are still NOT scientifically known for the products that are to be sold by these 2 firms - do not appear to be justified in terms of the benefits.

Silicone breast implants were a magical train that just could not be stopped at this time.

Suzanne Parisian, MD
Arizona

[Dr. Parisian is presently acting in the USA as an expert for plaintiffs involved in court cases related to HRT and breast cancer.]