UK to Pay for Removal of Faulty Breast Implants

(NewsCore) - The British government said Friday there was no evidence to recommend the routine removal of the breast implants at the center of a global health scandal, but will pay for concerned patients who had their procedure on the taxpayer-funded National Health Service (NHS) to have them removed.

About 40,000 women in the UK have had the implants -- produced by the now-closed French firm Poly Implants Protheses (PIP) -- which have been withdrawn in France because of fears they would rupture and leak silicone into the body.

But only five percent of Britons had them during NHS breast reconstruction surgery.

The government said it expects private clinics to offer the same deal to their patients.

A statement from the Department of Health said, "We believe that private providers have a duty to take steps to provide appropriate after-care to patients they have treated."

The implants have been pulled from the market in several countries in Europe and beyond. France, Germany, the Czech Republic and Belgium have all advised that patients who were fitted with them should have them taken out.

But a UK government review ordered by Health Secretary Andrew Lansley concluded there was no greater risk of harm from the PIP implants than others and no risk of a link to cancer had been found.

However, Lansley said, "We think there is a standard of care that should be provided to women.

"They should have information about what implant they have, that they should get access through a GP [general practitioner] or a specialist to advice, imaging scans if necessary, and on the basis of that if necessary their removal."

He confirmed that if a doctor found there was a clinical need for a private patient's implants to be removed, the procedure would be done on the NHS if the clinic was unable for any reason.

The review, conducted by experts, said it was "undeniably the case" that they were made of non-medical grade silicone, but was unable to establish if the rupture rate with PIP implants was higher than others.

It also said that in those PIP implants that have been tested, there was no risk of dangerous toxins leaking into the body from a rupture.

However, it was revealed that PIP was warned about the content and safety of its breast implants at least seven years ago.

A report by a consultant plastic surgeon in Los Angeles in 2005 warned that PIP implants were three-and-a-half times more likely to rupture than a test group.

Dr. Grant Stevens compared 500 PIP implants with 500 implants manufactured by Mentor Siltex. After four years, 15 percent of the PIP implants had ruptured compared to just four percent of those made by the other brand. Stevens claims that at the time, PIP asked him not to report his studies.

PIP was also accused by its insurers a year later of deliberately concealing complaints from regulators, surgeons and clinics.

Sky News obtained a copy of a letter PIP received from its insurers in 2006, accusing it of failing to notify them or French regulators of incidents that would necessitate the implants' removal, despite it being compulsory to do so.

"We are observing there are over 4,000 claims. PIP received 466 claims before 1999 and 1,783 claims between 2000 and 2002. Until 2005 our company was notified of only four events," the letter said.

"Your company has therefore systematically concealed for many years the claims received from surgeons or clinics in relation to incidents and removals of your prosthesis," it added. "We hold that PIP, by a deliberate, willful and financially-rewarding violation of the regulations, prevented the authorities conducting an inquiry to try [to] stop the incidents."

The letter was one of several warnings about PIP dating over a decade.

In March 2000, US regulators found 11 deviations from "good manufacturing practices" at the PIP factory in France.

In February 2009, the UK regulatory authority was warned of a number of medical claims against the company, which is based in La Seyne-sur-Mer near Toulon in southeastern France.

British lawyer Paul Balen who has fought PIP for 12 years said it was "common knowledge" in the cosmetic surgery industry that PIP implants were inferior.

"Almost without exception, I've been told by expert after expert and professional after professional, that PIP are poor quality implants," Balen said. "They fail earlier; they're cheaper than other implants that could be used instead; it seems to have been common knowledge in the profession."