Tuesday 10 January 2012

British Statement on Defective Implants Offers Limited Help

AppId is over the quota
AppId is over the quota

“It is undeniably the case that these implants are made up of non-medical-grade silicone and therefore should not have been implanted in women in the first place,” the health secretary, Andrew Lansley, said in a statement.

His remarks did little to assuage the fears of about 40,000 other British women who unwittingly paid for the poor quality implants during cosmetic surgery in dozens of private clinics where the bulk of the implants here were done. Responding to the announcement, which was supposed to clarify the government’s position on the growing breast-implant scandal, many women said they were more confused and frightened than ever.

Mr. Lansley urged those clinics to follow the health service’s example, saying they had a “a moral duty to offer the same service to their patients that we will offer to N.H.S. patients: free information, consultations, scans and removal if necessary.”

But while he said the government would pursue the clinics “with all means at its disposal to avoid the taxpayer picking up the bill,” Mr. Lansley offered no indication that the government could force the clinics to do anything.

Kevin Timms, a lawyer at Garden House Solicitors who is representing a number of women with the implants, manufactured by Poly Implants Prothèses, or PIP, said that the statement had not cleared up the concerns of his clients.

“The guidance, if you can call it that, doesn’t change the government’s position at all,” he said. “The government is taking the moral high ground in respect to N.H.S. patients, but all they’ve done is suggest that the private clinics follow suit.”

Rowena Mackintosh, 30, who has PIP implants, has already come up against the intransigence of the clinic that put them in. She paid $6,500 for the implants in 2008 after being assured that they would not rupture or leak. Eight months later, she began to feel aching and burning in her left breast, and developed a lump — a classic sign that silicone was oozing out of the implant.

An ultrasound then found a “black mass” near the breast, Ms. Mackintosh said. But after determining that it was not cancer, she said, her National Health Service doctor “stuck his nose in the air” and told her to consult the private clinic again. When she called, though, the clinic refused even to test whether the implants had ruptured.

“They were rude; they were obnoxious,” she said. “I have not had a single word from them — no support, no nothing.”

Until now, most private clinics have refused to pay to remove and replace their former patients’ PIP implants, saying that they installed the devices in good faith and that redoing all that surgery would prove ruinously expensive. But on Friday, several clinics changed their minds and said that free consultations, at least, would be made available to worried patients.

But it is unclear which clinics will be willing to replace implants that have not begun to leak but whose presence is frightening to the women who have them.

“Obviously, there’s differing opinions in some companies,” said Sally Taber, director of the Independent Healthcare Advisory Services, which represents a majority of private clinics.

Some clinics have gone out of business since installing the implants, and the government said it would allow those women to seek treatment from the health service.

Britain banned the PIP implants in 2010 when it became clear that the company was using silicone intended for industrial, not human, use. It urged clinics using the implants to contact any patients who had them, but it appears that few, if any, took that advice.

Meanwhile, it emerged on Friday that PIP’s chief executive, Jean-Claude Mas, admitted to the police last October that the company used the low-grade material “because it was less expensive,” according to a police transcript first published by Agence France-Presse. Mr. Mas also told his staff to “hide the truth” from German inspectors responsible for ensuring that the implants met European regulations by concealing documents and making containers “disappear.”

Doctors and patients began reporting leaks and ruptures in PIP implants, often accompanied by symptoms like fibromyalgia, a musculoskeletal pain and fatigue disorder, as early as 2005, but the implants were still widely used in Britain.

In his statement, Mr. Lansley also admitted that the government did not have adequate information about the safety risks associated with the implants, despite ordering the private clinics to provide data on ruptures and other complications earlier this week.

Many prominent plastic surgeons here have said publicly that the implants should be removed as a matter of course because they are unfit for use in humans, but the government has failed to follow suit, saying it was waiting for data from the clinics.

“Throughout this process we have followed expert advice,” Mr. Lansley said. “The data available to the experts has not been good enough to enable them to give a clear recommendation of the risk posed by PIP implants.”

The French government, which apparently keeps better records, says the rupture rate for the PIP devices is about 5.5 percent, more than five times the industry standard. It has said it will pay to have them removed from women, but will not pay for replacement implants.

The authorities in Germany and the Czech Republic recommended Friday that women with PIP implants in those countries should have them removed, too.

Mark Harvey, who is head of litigation at the Hugh James law firm and is representing about 600 women seeking to sue the clinics that gave them the implants, said that Friday’s statement showed how little authority the government had over the cosmetics industry.

“By only making a suggestion that the cosmetic industry should follow the example of the N.H.S., the government again leaves women vulnerable,” he said in a statement.

“From our clients’ experiences with many of these clinics to date, they have shown affected women no sympathy or support,” he said. “We are extremely concerned that this announcement will again allow cosmetic clinics to leave women to try to sort out this serious problem alone.”


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