A new report from a top U.K. health regulator could help to deflate some of the hysteria left in the wake of a scandal over substandard breast implants in the European Union. Bruce Keogh, medical director of Britain's National Health Service, concluded that implants made by France's now-defunct Poly Implant Prosthese rupture more easily, but didn't pose any long-term health risks to women who had them, according to The Associated Press story.
Governments across Europe, Australia and elsewhere became alarmed late last year over a report concluding that women who received the PIP implants were more likely to face health problems than those who didn't. The company is now defunct because of the scandal and the PIP implants were pulled from several markets over concerns that they could rupture. European regulators proposed an implant registry and more stringent checks, and the U.K. government rebuked regulators, arguing that they should have employed tighter scrutiny.
The National Health Service in Britain commissioned Keogh to investigate the matter in December, considering that 47,000 British women were thought to have received the PIP implants. He was sent to work, studying 240,000 implants given to women in England made by various companies, and also combed over related data from France, Australia and other countries.
Of course, the study doesn't put the PIP implants in the clear. Keogh notes that they are still made of substandard materials (industrial silicon instead of the typical medical-grade version), and that they ruptured more easily than competitor brands. Interestingly, the finding contrasts with Australian regulators, who found that that existing evidence showed no increase of rupture for Australian women who received the PIP implants.
Regulatory response is varying by country. In France, for example, the government will pay for 30,000 French women to have their implants taken out. The U.K. government said it would remove the implants put in by the National Health Service for patients with other issues, such as cancer. And in the Czech Republic, the government is negotiating with health insurers on how to cover implant removal costs.
- read the AP story here (via Bloomberg Businessweek).