Showing posts with label British. Show all posts
Showing posts with label British. Show all posts

Thursday, 12 January 2012

British Seek Data to Help Decide on Breast Implant Removal

AppId is over the quota
AppId is over the quota

“The question really comes down to the extent to which these implants fail relative to normal implants and the relative risks of their removal compared to the risk of having an operation,” Mr. Lansley told BBC radio.

Mr. Lansley was acknowledging that the British authorities did not have reliable statistics on ruptures or oozing of the implants, throwing into doubt the basis for their earlier recommendation that women with the implants in question not undergo “routine removal.”

The French government recommended on Dec. 23 that the 30,000 Frenchwomen with the implants have them removed, citing a failure rate of around 5 percent, a figure they have since raised to about 5.5 percent, calling it unacceptably high. The silicone gel inside them causes inflammation.

British officials at the time cited their own finding that the failure rate among more than 40,000 British women was closer to 1 percent to support their recommendation against removal, an operation performed under general anesthesia that carries its own potential risks.

Nigel Mercer, a former president of the British Association of Aesthetic Plastic Surgeons, said the government lacked data on how many British women have implants that have ruptured. But he said the real issue was not the numbers, but the risk posed by the implants’ use of industrial-grade, not surgical-grade, silicone.

“The British government is all hung up on the rupture rate, but that’s missing the point,” Dr. Mercer said. “It’s what’s inside the implants. It’s not fit to be inside a human being.”

The silicone gel inflames body tissues if it leaks, and the leaks also raised fears of a possible link to cancer. Health authorities around the world have issued statements saying no link has been found.

With British private clinics reportedly charging up to $4,690 to remove the implants, the overall cost could be more than $187 million for 40,000 patients, a burden the National Health Service is loath to bear.

The French government is paying the cost of removal for its citizens. The national health system estimated that it would cost about $77 million to treat all 30,000 French patients.

Mr. Lansley, the British health secretary, acknowledged in a statement that “this is a worrying time” for women who have implants made by Poly Implant Prothèse — known as PIP — and he sought to place the responsibility for care on the doctors who implanted the devices.

More than 300,000 women outside France — mostly in Western Europe and Latin America — also received PIP implants. None are known to have been sold in the United States.

The French daily Le Monde reported on Tuesday that TüV Rheinland, the German company responsible for assuring that PIP implants met European regulations, was being sued by distributors in Brazil, Bulgaria, Mexico, Thailand, Syria and Italy.

TüV Rheinland said last week that it had been deliberately deceived by PIP, which used high-grade silicone when TüV’s inspectors were present and returned to the substandard product after they left. It said it filed a criminal complaint against PIP.

French officials are also turning up their scrutiny of Jean-Claude Mas, the founder of PIP. Mr. Mas, who is already the subject of a fraud investigation by Marseille prosecutors over the implants, was questioned on Monday by the French agency that deals with the safety of health products, French news media reported.


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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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Saturday, 7 January 2012

Global Update: new H.I.V. cases and collapse of death related to AIDS in British Columbia Colombia

New H.I.V. cases and AIDS-related deaths are in constant decline in British Columbia Colombia, according to the output data last week.

"We are particularly pleased to see that our treatment as a prevention strategy has taken off big-time,", said the Dr. Julio s. g. Montaner, Director of the Centre of British Colombia for Excellence in H.I.V./AIDS. Its centre is a pioneer in the strategy, which is to aggressively seek individuals at risk for H.I.V. infection, speak them tested and involving those who are infected on antiretroviral therapy immediately, which reduced 96% chance that they will be infecting others.

In Vancouver, where he worked, AIDS is concentrated in two distinct groups in large part: homosexual men and drug users. To reach drug abusers, the city opened a centre where they can inject under the supervision of a nurse without fear of arrest; nurses also provide medical care, including testing.

Tests increases, and syphilis rates are stable, said Dr. Montaner, the fall in new cases is not a result of less of tests or greater use of condoms.

AIDS cases remain constant in other Canadian provinces, except those in the Prairie region, where they have tripled, mainly among Indian addicts in Saskatchewan, which has no centre of safe injection.

Last week, the Science magazine named the strategy of treatment as prevention, clinical trial of 1 763 couples on four continents has proved that he has worked, as its 2011 "breakthrough of the year".

Dr. Montaner said it was frustrated that rich countries do not give enough money to implement the strategy in poor countries with huge H.I.V. epidemics.


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