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Silicon Breast Implant Scare in Europe and So. America (Part 3)

By On · Add Comment · In Argentina, Brazil, breast augmentation, breast implants, Columbia, industrial silicone, medical quality silicone, ruptures, silicone implants, South America, Venezuela
See Part One here; Part Two here.

South American authorities are considering their next move on the heels of the French government’s recommendation that 30,000 French women have their silicone breast implants, manufactured by Poly Implant Prothese (PIP), removed. The now-bankrupt French implant manufacturer is facing criminal charges as its chief executive is on the lamb, wanted by Interpol and Costa Rican authorities for crimes involving “life and health.”

Tens of thousands of women in over 65 countries around the world have the same implants, made from industrial rather than medical quality silicone. The implants are also said to be at an unusually high risk for rupture. Most of the women having received the PIP implants live in South America and western Europe.

The implants are particularly widespread in Venezuela, Brazil, Colombia and Argentina across different economic levels, with many young girls eager to augment their bust size before they become adults.

In Brazil, a National Health Surveillance Agency (ANVISA) spokesperson said that it “has not yet made a recommendation,” echoing the sentiments of health professionals and officials in other Latin American countries. He states that the French government also recognized an as of yet unproven cancer risk to ruptured PIP implants.

Ironically, PIP implants were banned in Brazil in April 2010 when problems were first reported, but 25,000 implants had already been performed in the country, according to ANVISA. Around 100,000 women get silicone breast implants in Brazil each year (including Americans). Silicon implants were banned in the U.S. for fourteen years until 2006 when the restrictions were lifted.

“The medical facts that we know suggest that these implants can rupture earlier and with a greater risk of inflammatory reaction,” said Brazilian Society of Plastic Surgery president Jose Horacio Aboudib.

Aboudib said his group in Brazil recommended that women who received the implants get tested early to make sure the implants were viable.

Venezuela’s union of plastic surgeons agreed, declining to recommend that women with the PIP implants get them removed, recommending preventative checkups instead. About 40,000 breast augmentations are performed in Venezuela each year, and plastic surgery is widespread in a country that has produced regular top contenders for Miss Universe over the years.

Surgeon Juan Jorge Blanco noted that breast augmentations used to be prohibitively expensive but that costs have since dropped to $3,000-7,000. “Women from all social backgrounds now get operations,” he said.

Argentina’s ANMAT drugs authority urged 15,000 women who received implants to “consult” their doctors.

In Colombia, implants are sometimes offered as birthday gifts, especially for “quinceaneras”–girls’ 15-year-old birthdays–that mark a girl’s passage into young womanhood.

“Drug traffickers also offer the surgery as a gift to their girlfriends,” said surgeon Celio Bohorquez, spokesman of the Colombian Society of Plastic Surgery.

This cosmetic surgery scandal is multiplied exponentially by the hordes of women who have run to surgical enhancement over the last couple decades. It really put the practice into its massive perspective, as we see the scare affecting up to 300,000 women in over sixty countries.

My advice to the women of Latin America, and to tourists taking advantage of the rock-bottom prices of plastic surgery in foreign countries, be extra careful. Usually regulations are much more lax outside of the U.S. and Europe, and as I have said in this blog–any unproven and risky drug or procedure will find its way to South and Central America sooner or later by rogue practitioners or corporations ready to make a buck.

The surprise to me is in the brazenness PIP showed in its safety protocols and practices. I recommend that all women suspecting that they may have silicone breast implants manufactured by PIP to call their surgeon to discuss removal options and risks. Once again, my sympathies to any and all involved.

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

By On · Add Comment · In Britain, cancer, Costa Rica, Europe, France, Jean-Claude Mas, Medicines and Healthcare Products Regulatory Agency (MHRA), PIP breast implants, Poly Implant Prothese, silicone implants, South America
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)

By On · Add Comment · In Britain, cancer, Costa Rica, Europe, France, Jean-Claude Mas, Medicines and Healthcare Products Regulatory Agency (MHRA), PIP breast implants, Poly Implant Prothese, silicone implants, South America
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.

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