Cancer causing implants causing major waves in France...
This past week, the French government announced that it will pay for of thousands of women to have their breast implants removed amid concerns that certain silicone implants are linked to a rare form of cancer called anaplastic large cell lymphoma.
The type of implant that is being targeted, made by a company called Poly Implant Prosthese (PIP), is more prone to bursting and is no longer available because the company is no longer in business.
According to the British Association of Aesthetic Plastic Surgeons, Poly Implant Prosthese used non-medical grade silicone that is normally used for mattresses and other non-medical items to make their implants.
The French government says that 523 women have had their implants made by PIP removed since 2010 and more than 1,000 PIP implants have ruptured since then. So far, the French government is saying that it will only pay for the surgery to remove the PIP implants if the original reason for surgery was of a reconstructive nature.
Around 30,000 women have these implants.
It is good that the French government is being proactive in bringing these defective implants into the media spotlight so women are more aware of what they are putting in their bodies when they have breast implant surgery.
It is troubling, however, that the government is only willing to pay for the surgery to remove the PIP implants if the woman who has the implants has them because she needed breast reconstruction surgery.
What about all of the women who had elective breast augmentation surgery? The French government approved the PIP implants for any breast implant surgery, regardless of whether the implants were for reconstruction or augmentation. Now that the implants are being recalled, all of the women in France who had implant surgery for whatever non-reconstruction reason they had are being left out in the cold.
Think what you will about breast implants being used purely for the purpose of augmentation. Regardless of where you stand on the "Is she really getting those implants for herself?" question, you have to admit that it is a raw deal that not ALL of the women who have these implants are being taken care of medically.
Let's put this in perspective with US breast implant statistics, shall we?
According to the American Society of Plastic Surgeons, nearly 300,000 women had non-reconstructive (i.e. - there was nothing medically wrong with these women's breasts, the women just wanted their breasts to be bigger) breast implant surgery in 2010 in the United States.
Imagine if even just 1% of those implants were recalled. 3,000 women would be walking around with unsafe implants.
Now imagine how horrible it would be if you were a woman who wanted to go from an A cup to a C cup and achieved that via an FDA approved implant only to later learn that implant might give you cancer. Then imagine being told that because you had the surgery for non-reconstructive reasons, you had to figure it out on your own dime how to get the defective, government approved implants removed.
In a world where people regularly decry government intervention in everyday life, one has to admit that if governments are going to regulate the safety of products available to consumers, they better also figure out a way to protect the consumers if those same government approved products turn out to be unsafe. Otherwise, what’s the point of having the government regulate anything, at all?
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Sally,
Are you suggesting that every time the FDA erroneously approves a procedure and later revokes that approval, it has to pay for people to have the procedure reversed? Really? Do you think the U.S. would stay in the regulatory business if it were subject to that kind of liability? What about the insurance companies? Aren’t they responsible for fallout since they were the ones who invented, marketed, and sold the products? In the health care system your describing, I’d quit my job and go into the health insurance field. We’re not France, Sally. Because our government doesn’t pay for our health care like France’s does, your comparison ianutterly inapt. Until you learn a little more about how each system works, you may want to bow out of this debate.
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Powerwalker:
Close, but no cigar. Insurance companies are not responsible for inventing, marketing, or selling any products. In fact, companies like Merck, Pfizer, and even Johnson & Johnson are responsible for inventing, marketing, and selling products. Insurance companies are engaged by pharmaceutical companies to insure their product. Should a drug (implant, etc) be found to be dangerous, the company will recall it. Typically, patients and their insurance companies (private medical insurance) will pay for the reversal. Litigation will then ensue to recover the costs of reversal and other damage. Insurance companies will pay the damages or settlement, if any.
That said, I agree with Powerwalker that because our government does not pay for health care, the comparison is inapt. France is going to pay to remove the dangerous implants that were deemed medically necessary (ie after a mastectomy) but is not goint to pay to remove the implants that were a). paid for by the patient and b) were cosmetic. To me, this is fair and consistent.
Finally, if the patient is willing to spend $X on breast implants for cosmetic purposes, surely she should be willing to spend $y on preventing cancer. I’m not sure I understand why this is as outrageous as Ms. Turkovich seems to preach.
Hello Knitty
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I think that if the government approves a procedure or a product, then they are responsible for the outcome of the safety of that product or procedure. If, like in France’s case, the government backtracks, causing thousands of women to be placed in harms way, then they should be responsible for cleaning up the mess they made. I definitely want to live in that kind of society where the government takes responsibility for its people or what’s the point of regulating anything?
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The point of regulating anything to provide a base threshold of safety for both people - in this case - as consumers and patients. The point of regulating is not to ensure safety or to guarantee a product, which is what Twoday seems to be suggesting. Were that the case, our government would be bankrupt from excessive litigation.
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I disagree. If they declare it safe, then they need to man up if there is a recall just like other companies do if a recall is needed on a product. If the government is willing to reimburse for some, they should reimburse for all or they are going to end up paying much more severe costs when these women need cancer treatments.
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There is no “declaration of safety.” In the US, there is an approval after a product meets certain requirements. “Approved” does not mean “safe.” All drugs (implants, etc.) are accompanied by risks and warnings which must be taken into consideration by physicians and patients.
In this case, after the French agency (the correlary to the US FDA) approved the implants, the country paid for certain individuals to get the implants. The country is paying to remove those for which it paid. France is not paying for the implants which were implanted for cosmetic reasons at the patient’s own cost.
Natlie, your argument suggests that France should pay for removal of the implants to save itself future cost of cancer treatment. This is a sound argument, but it is not the same argument as in Ms. Turkovich’s article. She says that there is some inconsistency with France refusing to pay for removal of implants for which it did not pay to implant in the first place.
I still don’t understand the supposed outrage at France’s fundamentally consistent position.
Hello Knitty