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Controversy over breast implants spreads across Europe Date: 02/07/12

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The Reuters enterprise team has a special report on the breast implant scandal and a piece that shows how the regulatory system may be another scandal waiting to happen. It also looks at how the FDA handled an application from PIP in 2000.

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By John Lister

British clinics delivering cosmetic surgery were thrown into crisis by the decision last month of the French government to fund the removal of thousands of breast implants manufactured by the now-closed French company Poly Implant Prostheses (PIP). The implants were found to have used industrial grade silicone made for use in mattresses.

Ninety-five percent of all United Kingdom breast implant operations are performed privately, with the National Health Service only undertaking any cosmetic surgery after mastectomy, severe burns or in a few exceptional cases where clinically justified. Relatively few NHS patients were given PIP implants.

But when it came to ascertaining the numbers of women who may have had PIP implants in British private clinics, it became clear there was no comprehensive or reliable data. A working estimate of 40,000 women potentially at risk eventually emerged, while the private clinics said they were not required to remove the suspect implants or replace them with safe ones. Yet the figures that were available showed that for one clinic as many as 7 percent of PIP implants had leaked, well above initial claims of a failure rate of about one percent.

The biggest number of PIP implants had been inserted by the Harley Medical Group, whose website still proclaims it to be a leader in the field, and that “breast enlargement is our most popular procedure.” But rather than respond to the understandable concerns of the 14,000 women they eventually admitted had received the implants, the Harley Group publicly tried to pass the problem over to the NHS, arguing that the cost of removing the implants would put them out of business.

As the pressure mounted and a demonstration of angry women targeted the Harley Group as the largest company refusing to remove or replace PIP implants, the Group’s chairman Mel Braham insisted it was the “moral duty” of the NHS to step in and provide free treatment to his clinic’s worried customers, while the company was prepared to replace only implants that had failed within two years.

Braham blamed inadequate regulation of the quality of implants at the Medicines and Healthcare Regulatory Agency (MHRA), which had complied with an EU directive that approved the PIP implants back in 2000, on the strict condition that medical grade silicone was used. The company decided to switch to the cheaper industrial silicone the following year without disclosing this to any regulatory agency.

However as Lancet editor Richard Horton has pointed out, there were warnings about the quality of the PIP product in the UK back in 2007, and the MHRA itself noted concerns in 2008, but did nothing. In 2010 Brazil and other Latin American countries banned the use of PIP implants because of quality concerns, but still British authorities did nothing.

Even as the French government took action at the end of last year, the first reaction of the MHRA was to dispute the figures, disagree with the French decisions and claim that there was no reason for concern.

But as public and media pressure mounted, some private providers agreed to remove suspect implants without charge.  First the NHS in Wales (which is run autonomously by the Welsh National Assembly) agreed to replace PIP implants for women, and then the English NHS was eventually obliged to follow suit.

However, NHS surgeons in England will remove the PIP implants, but will not insert replacements, since the NHS does not do cosmetic surgery. And many women are fuming that they have paid thousands of pounds for operations (despite the fact that the implants cost only a few hundred) but cannot now have their suspect implants replaced by the companies that made profits from their treatment.

There are larger questions about the limited regulation of the cosmetic surgery trade, where those conducting operations require limited qualifications – and about the extent to which private health providers would be publicly accountable in future for services delivered to the National Health Service if the Health and Social Care Bill (now in the House of Lords) eventually completes the parliamentary process.


John Lister, the European web coordinator of AHCJ's focus on Europe, has been a journalist for 35 years, specialising in reporting health policy in England. He is a part-time senior lecturer at Coventry University.