I’m sure anyone who has read a newspaper in the past few months is aware of the fears that are engulfing (of should I say filling) the French women who have received silicone implants. A company in France produced a popular (and apparently not too expensive) implant termed the Poly Implant Prothese (otherwise known as PIP). It was sold in 65 countries throughout the world over the last decade and used for breast augmentation or reconstruction in more than 300,000 women. The company that made the implants was shut down by the French government for fraud in 2010. It turns out that they had been using industrial grade silicone that was (obviously) not approved for medical use. The concern was (aside from the fact that no woman wants her breasts augmented with the same stuff they use in building or road construction) that these implants were far more likely to rupture…. apparently of the 30,000 French women who have had these implants, 1,000 experienced a rupture or leak. The French are advising those women who still have PIP implants to have them removed. Other countries are deciding what to suggest and many are simply suggesting that the women discuss “what to do” with their physician.
Why has this not been a problem here in the USA? This timely question was addressed in an article in the January 14th issue of Lancet titled “Silicone breast implants: lessons from the USA.”
The silicon-gel implants that are used in our country have been FDA approved after a long and arduous history. Currently the FDA assures us that they are safe. Their approval has allowed 150,000 American women to get silicone-gel implants for breast augmentation and 46,000 women to get them for breast reconstruction in the last year alone. In 2010 after 2 days of public testimony from silicon implant manufacturers, surgeons and scientists, the FDA concluded that American women can “consent with confidence to procedures involving silicon implants, which are considered safe but with acceptable risk of local complications (rupture, tissue hardening, pain, inflammation, and infection).” (Note the same complications occur with non-silicone, i.e. saline implants.) And just to be more precise the FDA published a 63 page report assuring the safety of silicon-gel implants.
There is quite a chronicle that preceded this. Silicon-gel implants were available in the US since the early 1960’s, but not until 1976 were they regulated by the FDA. In 1988, the FDA classified them as devices (duh) that needed their safety and efficacy to be proven in order to stay on the market. They gave the manufacturers 30 months to provide the necessary data. Apparently they could not. In 1991, it was deemed that the data did not fully assess the risks and in 1992 (this s a history lesson!) the FDA imposed a moratorium on silicon-gel implants. They were only to be used for reconstruction (after mastectomy for breast cancer or redoes of bad previous implants) and not electively for augmentation until their safety was proven. Then all hell broke loose (at least litigiously) and in 1995 the biggest US class action lawsuit took place, for $4.3 billion. Subsequently, publications in peer-reviewed journals and a 400-page report of the Institute of Medicine failed to link systemic disease with silicon breast implants. The ban was lifted in 2006 and since then 2 manufacturers; Mentor and Allergan have supplied the US market. They have promised to conduct ongoing post-approval studies and are following 40,00 women for 10 years,
So right now we feel (sorry about the use of this word) that our silicon-gel implants are safe. The authors conclude with the statement that “some critics argue that the FDA’s approval process is too slow and bureaucratic” But they add “but at what cost to safety?”
I agree with them. We should expect no less.