Silicone Breast Implant Controversy

Silicone Breast Implant Controversy

 

The recent controversy over the silicone breast implants made by PIP (Poly Implant Prothes), the now defunct French company that manufactured leaky silicone implants, is growing.

Over 1,000 French women have already had the leaking silicone implants removed. Saline implants are not part of the problem so far. The French PIP implants were found to have been manufactured with substandard silicone—more like the type of silicone used in caulking for your windows than the medical-grade silicone used by United States companies in the manufacture of breast implants for breast enlargement or reconstruction.

Over 40,000  of these faulty breast implants implants have been placed in patients in Europe. Another 40,000 have had the PIP implants placed for breast augmentation in the UK. See this recent article:
http://www.google.com/hostednews/ukpress/article/ALeqM5gT7zv9bRLfG6B8JRWAB-56ZA7BoQ?docId=N0843311325898288117A

The medical disaster has reached South America, another main area of sales for these breast implants. It should be noted that the PIP implants have not been approved for sale or use in the United States by the FDA since 2000.

Four hundred Venezuelan women with these breast implants have sued for the costs associated with breast implant removal and re-augmentation.

The debate has now entered the realm of blame and, naturally, the question of who is “responsible” for the costs associated with the breast implant removal and replacement surgery. These costs range between $4,000 and $8,000, depending on where in the world you are!

Some of the current programs are:

In the UK – If the implant was placed by the National Health Service, they will take it out and replace the implant with another approved breast implant—if the implant has ruptured. The UK government at present is playing a “let’s wait and see” game regarding breast implants that have not ruptured. It should be noted that most plastic surgeons in the world are recommending removal of the PIP implants in all patients regardless of their state of rupture.

In the UK – If it was placed by a private cosmetic plastic surgeon, the onus for the surgery  and associated costs is being placed on them. I doubt any cosmetic plastic surgery practice in the world will be able to redo the surgery and cover ALL associated costs for free. They would lose tons of money and go bankrupt.

In France – The government has taken on some of the responsibility of allowing the company to manufacture the faulty breast implants that have a rupture rate five times that of standard silicone breast implants  (5.5 % vs. 1%) made by US companies Mentor or Allergan. However, the French government will only pay for the implants to be removed and will not pay for re-enlargement surgery with breast implants. This absurd policy will leave thousands of women deformed. A breast that has been enlarged will have had its skin stretched. Removal of the implant will leave the unfortunate patient with a droopy, small breast that is cosmetically unacceptable anywhere in the world!

In Venezuela – The women with PIP implants that were sold by five different companies to plastic surgeons and cosmetic practitioners are asking the Federation of Medicine, a sort of AMA, to foot the bill. They also hold the French government responsible for ineffective oversight and regulation of the industry.  Let us not forget that in the United States, some states  like Virginia have a precedent whereby the state imposes mandatory yearly fees on all doctors who practice in the state to cover the costs and settlements for legal suits arising out of childbirth injuries under the supervision of obstetricians practicing in the state. All pay to cover a few.

The ensuing controversy has raised calls for stricter European monitoring of medical devices, similar to what we have in the United states. See this article for more:
http://www.ft.com/cms/s/0/3f87dea4-3886-11e1-9ae1-00144feabdc0.html#axzz1ijjPc2nF

The different approaches by the different governments and systems make for interesting legal theories and briefs.  Some of my beliefs on the subject include:

1. Irrespective of who bears the cost, the implants should be removed.

2. If the manufacturer of the breast implants is a viable entity, they should the cover the cost of the surgery for implant removal and re-augmentation.

3. The government that supervised, regulated and placed their stamp of approval on the breast implant is responsible  for allowing the implant to reach the market. They must bear some accountability—otherwise what is the point of their existence?!

4. As a plastic surgeon, I rely on the fact that the implants being sold to me are manufactured under the laws of a country and meet a minimum of safety standards. I am responsible for the technique of the surgery but cannot be held responsible for the implant sold to me for my patient.

5. The doctors could perform the implant exchange surgery without a surgical fee for their own patients (as I currently do for patients with deflation, capsular contracture or rupture of implants). Surgeons could be remunerated from a public trust set up by the government for performing surgery on patients who no longer have or can locate their cosmetic surgeon.

6. If a country has a nationalized health system, that system is responsible for breast implant exchange surgery costs. The “system” allowed the implants into the market place.

7. Is the country of the manufacturer responsible for the costs?  I asked my lawyer wife, and that’s where it really gets complicated…

 

Here is a recommendation put out by the American Society of Aesthetic Plastic Surgery today:

http://www.surgery.org/private/pip-implants-guide