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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.

Vaccination Guinea Pigs

By On · Add Comment · In Argentina, experimental, pneumonia, Synflorix, vaccine
Wanna know the best way to test a new experimental vaccine? Give it to unsuspecting poor people. Want to know how to get away with shoddy recruitment practices when you get caught–make sure those poor people are in Latin America. Don’t believe me? Read on.

According tho the Argentina’s food and drug administration, an investigation is being launched into the possible link between an “experimental” vaccine and the deaths of 14 children in Argentina and Panama. Pharmaceutical maker, GlaxoSmithKline, developed Synflorix as a vaccine to combat pneumonia–a noble undertaking–but sources say that the mega-drug maker may have used dubious tactics to recruit volunteers. One watchdog group says that many participants were not told of the experimental nature of the vaccine. “They didn’t explain to the parents that this was an experimental vaccine, and a lot of the parents who signed consent forms were illiterate,” said Ana Maria Marchesse, a pediatrician who heads the Health Professionals’ Labor Association in the northern Argentine province of Santiago del Estero, where seven of the 14 children died.

GlaxoSmithKline defends itself by saying that safety is always their utmost concern. In fact, they say, the number of pneumonia deaths among the experimental group was four times less than in the general population. Not bad numbers.

But “Uh, uh, uh, no, no, no…,” say doctors in the Santiago del Estero region of Argentina. They report that they witnessed “poor ethical management” of patient recruitment. “In some cases, they first gave them the vaccine and then gave them a 13-page consent form to sign that I had to read three times to understand,” Dr. Marchesse added.

A case of he said, she said? Hmmm…what do you think? I think we’ll be hearing more of this in the near future.

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