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BREASTS

France bans breast implants from new firm

France, still shaken from a faulty breast implant scandal that saw thousands of women suffering ruptures, has banned implants made by a South Korean company after the firm’s products failed to meet safety standards.

France bans breast implants from new firm
France has moved to ban implants from a South Korean firm over safety fears. Photo: Shutterstock

The national drug and health safety agency, ANSM, banned Hans Biomed Corporation from selling its products after the biotechnology firm refused to let its inspectors visit its production site, as it said its factory was being rebuilt.

ANSM said Hans Biomed implants were available in Europe under three brand names – Bellagel, M-Implants and Natureshape – but that these were not all available in France.

The agency was able to examine the latter two brands and said that “the quality of these breast implants highly questionable”. 

It did not elaborate on what the problems were, nor did it say how many, if any, women had had these faulty implants put in place.

No one was immediately available at ANSM to provide further details.

When ANSM revoked Hans Biomed’s authorisation in February this year it informed the European Union authorities of its move, who in turn informed national authorities across Europe.

Medical devices such as breast implants come under national and not EU responsibility, so it would be up to individual countries to decide whether to follow France’s lead. 

No-one was immediately available in Hans Biomed’s headquarters in Seoul to comment on the ban.

The news of the ban came in a major report published on Tuesday by ANSM inspectors who had visited all 11 sites in France where implants are made as well as the various distribution centres.

One French firm, Cereplas, was ordered to suspend its implant sales while it raised its standards to the legal norms but ANSM said its products did not pose a threat to health. 

The inspections were carried out in the wake of a scandal in which 300,000 women in 65 countries are believed to have received faulty implants made from industrial-grade silicone by French firm PIP.

More than 7,500 women have reported ruptures and in France alone more than 15,000 have had the PIP implants replaced.

The ANSM report painted a worrying picture for the 340,000 women in France who have had their breasts enlarged.

It said that that 2,169 women – aside from those who got faulty PIP implants – had since 2010 reported that their implants had ruptured.

The report said the breast implants on offer by various companies lasted on average 7.6 years, and not the ten years promised by their manufacturers.

It also said that women who had implants suffered more frequently from lymphatic cancer than the general population.
 
by Rory Mulholland

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HEALTH

Breast implants: New report a worry for women

Ruptures, implants that fail to last the ten years promised, and a heightened risk of lymphatic cancer - a new official French report paints a worrying picture for the 340,000 women in the country who have had their breasts enlarged.

Breast implants: New report a worry for women
A new health report on breat implants is a worry for French women.Photo: Web photographer/Flickr

The national drug and health safety agency, ANSM, said that despite measures taken to avoid a repeat of the recent global healthcare sparked by faulty French implants, the industry could do a lot more to improve safety and inform women of the potential dangers. 

And it said it had ordered a French and a South Korean breast implant company to stop selling their products in France as they did not meet safety standards. 

The report, carried exclusively by Le Parisien newspaper, said that 2,169 women had since 2010 reported that their breast implants had ruptured. 

It said this figure was separate from the cases of women who had implants made by the French firm PIP.

Some 300,000 women in 65 countries are believed to have received PIP implants made from industrial-grade silicone. More than 7,500 women have reported ruptures in the implants and in France alone 15,000 have had the PIP implants replaced.

The ANSM report said the breast implants on offer by various companies lasted on average 7.6 years, and not the ten years promised by their manufacturers.

It also said that women who had implants suffered more frequently from lymphatic cancer than the general population. 

Firms ordered to close until standards improved

ANSM inspected all 11 sites in France where implants are made as well as the various distribution centres.

The health agency’s boss, François Hébert, told Le Parisien that ANSM subsequently ordered two companies, Cereplas of France and Hans Biomed Corporation, a South Korean firm, to suspend their activities until they improved their standards to meet European norms.

Hébert said that cosmetic surgeons needed to provide better information to the women who want implants for cosmetic reasons or after having had breast cancer.

“Surgeons absolutely have to tell them, more clearly than they do today, about the risks involved,” he said. 

Breast implants have become hugely popular in France in recent years. Eighty percent of French women opting for breast enhancement do so for cosmetic reasons, with the remaining 20 percent having surgery after breast cancer.

PIP, which has now been liquidated, had been the third-largest global supplier of implants, but came under the spotlight when plastic surgeons began reporting an unusual number of ruptures in its products.

Health authorities later discovered the firm was saving millions of euros by using industrial-grade gel in 75 percent of the implants. 

PIP had exported more than 80 percent of its implants, with about half going to Latin America, about a third to other countries in western Europe, about 10 percent to eastern Europe and the rest to the Middle East and Asia.

PIP's founder Jean-Claude Masa, who was dubbed "the sorcerer's apprentice of implants" was jailed last year for fraud.

by Rory Mulholland

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