Faulty French Breast Implants May Upend

Since I first heard about women getting breast implants other than for prosthetic purposes, I’ve taken a hard stance against this disturbing trend. And now, finally, thanks to Marianne Mollman and her essay in the Huffington Post, people are starting to call a spade a spade, or should I say a scalpel a scalpel: “breast implants” is just a nice way of saying female mutilation, even if it is self-induced. To clarify, I’m NOT referring to reconstructive surgery after illness or injury. I’m referring to vanity- or insecurity-fueled desecration of a woman’s body.


The comparison to genital mutilation in developing nations has been made by the essay and spin-offs on the topic. On one hand people are saying that unsafe and unclean tools are frequently used in developing nations; however scandals like the France’s Poly Implant Prothese are demonstrating that unsafe tools and materials are being used in developed nations around the world as well. This company sold around 400,000 implants over a 20-year period until 2011 when it declared bankruptcy—financial bankruptcy, that is, but they should have declared moral bankruptcy as well.


The PIP breast implant scandal is an inevitable result” of regulators' “paralysis and inability to correct the failings of a flawed system,” Richard Horton, the editor of the British medical journal The Lancet, said in an editorial released yesterday. European approval “does not guarantee safety.”


On the other side of the Atlantic, U.S. device makers have complained for years about slow reviews and inconsistent standards at the Food and Drug Administration. At the same time, the agency has come under fire after high-profile recalls of technology it cleared for sale, from Johnson & Johnson hip implants to Medtronic Inc. defibrillators.


In a series of Capitol Hill hearings last year, industry supporters often cited the EU as a better model. Its speedier reviews were luring companies away, taking “good-paying American jobs” with them, said Representative Joseph Pitts, a Pennsylvania Republican, in a typical warning last February. A Stanford University survey of manufacturers, released in 2010, found complex devices reach the EU two years faster on average.