Issues with a French breast augmentation implant have renewed the debate about whether it is ethical for doctors to perform cosmetic surgery procedures purely for aesthetic reasons.
About 300,000 around the world received the implant made by Poly Implants Prosthesis (PIP), which were manufactured both by PIP itself and by a Dutch company out of Cyprus. They were legally used in people in 65 countries, including France and Great Britain, and they were also offered on credit to women in Venezuela and Bolivia, where some of the devices were smuggled in by medical tourists.
At issues is that PIP devices have been found to be more prone to rupture than any other breast implant, and that they contain an industrial grade of silicone that was not intended for use in medical devices.Reports have also surfaced that the devices can leak this unapproved silicone without the devices showing signs of rupture. Experts have also cited the case of a woman in France who died last year from cancer thought to be triggered by the PIP devices.
Jean-Claude Mas, the founder and chief executive of PIP, was interviewed by police in 2010, an interview in which he admitted to the use of the unapproved silicone, saying: “"I knew the gel was not standard but I did it consciously because the PIP gel was cheaper.” He added: “This formula is perfect, it is better than the one used to make standard gel.”
Unfortunately for Mas, medical experts disagree.
On hearing these revelations last week, thousands of women have sought to have the unsafe implants removed, and several governments have agreed to have their national health services cover the costs of removing and/or replacing the PIP implants.These governments have also asked any private clinics that had used the devices to perform their “moral duty” by doing the same.
In some cases – such as Great Britain – this advice was given even with a lack of consensus on the actual health risks of the devices.Just yesterday, Great Britain’s Department of Health said it had found “no evidence to warrant the routine removal of the devices,” but that women who had received the devices through the National Health Service (NHS) could have them removed and replaced by the NHS.
Experts say the scandal highlights problems with the international regulation of medical devices and the need for tighter standards and oversight on their sale and use. For example, Guido Rasi, executive director of the European Medicines Agency (EMA), has stated that medical devices actually need the same level of regulation as medicines in order to ensure patients are receiving only safe devices.
No silicone PIP devices were sold in the United States, primarily because the regulation of medical devices is much more strict in the U.S. than it is in Europe. Devices need only a “Conformite Europeene” (CE) approval rating in European countries, and this rating is much easier to get than the "stamp" given by the U.S. Food and Drug Administration.
