Silicon Breast Implant Scare in Europe and So. America (Part 2)

See Part One here.

PIP was placed into liquidation in March 2010 with losses of 9 million euros after the French medical safety agency recalled its implants. In a subsequent inspection of its manufacturing site, officials found it was using industrial silicone not approved by health authorities, and only about a tenth as expensive as approved gel.

An investigation found a majority of implants made by PIP since 2001 contained the unapproved gel. Industrial silicone is used in a range of products from computers to cookware.

While all breast implants can burst, especially as they get older, "these implants have a particular fragility" and appear to pose risks of rupture earlier in their life spans than other implants, said Jean-Claude Ghislain of the French health agency AFSSAPS. France's state health care system normally pays for implants for medical reasons, such as after a mastectomy, but not for cosmetic implants. About 80% of those with the PIP implants had them for aesthetic reasons.

A PIP lawyer says the company recognizes that its products were defective but argues that it is being unduly singled out.

"The implants had flaws but the PIP implants are not the only ones on the market that had problems," said lawyer Yves Haddad. "The reality is that everyone who makes implants has a percentage of failures."

According to him, company founder Mas is in France but does not intend to make public comment.

What can I say? Shocking is all that comes to mind. My heartfelt sympathies go to the women affected by this shameful act. Hopefully, everything will be sorted out quickly and decisively; but most importantly, may all the women involved get resolve with the most minimal consequences.

*Most of this piece consists of excerpts coming from various sources including Reuters, Associated Press, BBC and ChannelNewsAsia

Silicon Breast Implant Scare in Europe and So. America (Part 1)

Jean-Claude Mas

Hold onto your hats with this one, folks--it doesn't look pretty. The chief executive of a French company whose questionable breast implants are under international scrutiny is on the Interpol police agency's most-wanted list.

According to recent reports Jean-Claude Mas is wanted by Costa Rican authorities for crimes involving "life and health." It bears a photo of the 72-year-old Mas but does not elaborate on his alleged crimes or link to Costa Rica.

France's health ministry Friday advised 30,000 women with breast implants (silicone) made by the now-bankrupt Poly Implant Prothese (PIP) to have them removed, saying that while there is no proven cancer risk, they could rupture.

Tens of thousands of women in over 65 countries around the world have the same implants, made from industrial rather than medical quality silicone, although some reports have the number as high as 300,000 worldwide. Most of them live in South America and western Europe.

250 British women are suing for compensation after being fitted with the suspect breast implants. Some 42,000 women in Britain are thought to have the implants, according to a government watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA). The silicone gel implants, made by PIP, appear to have an unusually high rupture rate and fears about possible health risks are spreading.

French and British authorities appear to be taking very different approaches to the potential dangers. France has take the costly (euro60 million or $78 million) and unprecedented steps of offering to pay for the 30,000 women to have their implants removed.

In Britain, Chief Medical Officer Dame Sally Davies said:

"Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon." 

According to Davies, removing implants "carries risks in itself."  She does say, however, that women with these implants should be checked by their surgeons. 

MHRA in Britain says that France has reported rupture rates of around 5% for PIP implants, compared with 1% in the UK. Eight cases of cancer have been reported in women with the implants but the French authorities say these are not necessarily linked to faulty implants.

French  Health Minister Xavier Bertrand urged French women to have the implants removed as a "preventive measure," but said that it was not "urgent." The French Government did not move quickly enough for thousands of French women that marched on Paris to demand more attention to worries about what might be happening inside them. Images of leaky, blubbery implants and women having mammograms have been splashed on French TV. 

The implants were exported from France to Latin American countries such as Brazil and Argentina, and Western European markets including Britain, Germany, Spain and Italy. Local investigative police in Costa Rica said a man identified as Jean Claude Mas Florent was arrested by national police in Costa Rica's Cartago province on June 1, 2010 for reckless driving under the influence of alcohol, a crime that can carry a jail sentence. He was given a court date in November 2010 but fled the country. It was unclear if there was any link between that arrest and the Interpol notice.

Concerns in France first surfaced about two years ago when surgeons started reporting abnormally high rupture rates, leading to a flood of legal complaints, the company's bankruptcy and a scandal that has spread across the world.  

In the U.S., concerns about silicone gel implants in general led to a 14-year ban on their use, in favor of saline-filled implants. Silicone implants were brought back to the market in the U.S. in 2006 after research ruled out links to cancer, lupus and some other concerns.

Australia's healthcare watchdog says about 8,900 of the implants were used in women there, some of whom had complained about splitting and leaking.

Germany's medical safety board advised women with PIP implants to consult their doctors for checks, but stopped short of recommending their removal.

Go to part two here.