The controversy over breast implants made with industrial-grade silicon has fanned out across the globe but it doesn't always seem as though the reaction and the facts jibe. There is a push in some nations to get women to have the implants made by Poly Implant Prothèse (PIP; La Seyne-sur-Mer, France), removed regardless of whether that woman has had a problem with her implants, but one question persists: Is the reaction proportional to the available data?
The Jan. 12 news from Australia's Therapeutic Goods Administration is that tests of the implants indicate that both the shell and the gel were in conformance with ISO standards for material characteristics. In a Jan. 20 posting, TGA states that more than 12,000 implants made by PIP were shipped to Australia between 1998 and 2010, and that there have been 57 confirmed cases of implant rupture and 41 unconfirmed cases, a rate of rupture of 0.0082, assuming the unconfirmed cases are indeed ruptures. TGA also states that it has received no reports of anaplastic large-cell lymphoma associated with the PIP implants, but six cases of this cancer associated with other breast implants.
The UK's National Health Services apparently sees no particular reason to react immediately, either. In a Jan. 13 statement, NHS states that the available data, which it described as “patchy,” were not sufficient “to tell whether the rupture rate for PIPs is higher than for other types of implant.” NHS also stated that data from its own tests of the implants offer no evidence “of dangerous toxic effects in the event of a rupture.”
Going in the other direction are two non-Anglophone nations. The Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) recommended In a Dec. 23 statement that women contact their surgeons, who should propose removal “even without any clinical signs of deterioration of the implant.” AFSSAPS nonetheless also acknowledges “there is no increased risk of cancer in women who have PIP implants compared to other implants,” although the agency claimed that the rate of rupture for PIP implants was higher than with those made by other manufacturers.
As for Germany, Walter Schwerdtfeger, chairman of Germany's Federal Institute for Drugs and Medical Devices, is widely reported as having said the agency “recommends that the implants in question be removed as a precautionary measure.”
Some are recommending that all women have the implants removed, but that's no risk-free procedure. I'm having a tough time finding solid numbers on the event rates associated with implantation, but here's a list of some of those adverse events (which one might assume apply to explantation as well); bleeding, deep-vein thrombosis, scarring, and death due to anesthesia.
Now ask yourself this: If it's true that women with breast implants have a lower incidence of cancer than women without them, as some data suggest, what should the message be? What if the risk of suicide is higher for women who have implants, as yet other data suggest?
With the exception of France, I can't find any governments that are making the case that the PIP devices are demonstrably more prone to rupture, and nobody is claiming the PIP units are more likely to generate adverse events than other implants. This is not to exonerate PIP, which clearly had no business using an unapproved gel for their implants.
Still, culpability does not connect in a straight line to risk, so here's the question: Does it really make sense – based on the data currently available – to recommend a stampede to the operating room to get these implants removed?