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CARACAS, Venezuela (Reuters)—Some 2,000 Venezuelan women are threatening to sue doctors, private clinics and distributors for faulty PIP breast implants if they do not get free replacements in one of the world's hottest markets for plastic surgery.
The image-conscious South American country was disproportionately hit by defective breast implants sold by French manufacturer Poly Implant Prothèses S.A. (PIP) and filled with dangerous, industrial-grade silicone.
Local consumer protection group ANAUCO says Venezuela—famed for beauty queens, with six Miss Universe titles and six Miss World crowns—imported around 30,000 pairs of PIP implants over the past decade. PIP sold 300,000 implants worldwide.
ANAUCO plans to meet in the coming days with representatives of clinics, surgeons and the company which imported the implants to negotiate removal and replacement surgeries free of charge.
"If the doctors lend their hands, the clinics their operating rooms and (the importer) new prosthetics, we will have practically everything we need for these women to get surgery without cost," ANAUCO President Roberto Leon said.
"If negotiation doesn't work, in the next 30 days or so we will be suing all the actors involved so that everyone responsible pays their share."
He said around 2,000 women are interested in filing individual claims after an attempt to bring a class action suit stalled earlier this year after a previous legal team missed hearings. The numbers could not be independently verified.
Mr. Leon is also helping between 200 and 300 women join ongoing legal cases in France against PIP's jailed founder, Jean-Claude Mas, who faces both civil and criminal charges.
PIP went bankrupt, but Mr. Leon said the lawsuits the Venezuelan women want to join in France are also targeting German certification company TÜV Rheinland for compensation. TÜV Rheinland says its remit was to look into the manufacturing process, but not the content of the silicone, and that it was also misled by PIP.
Implants made by PIP, at one time the third-biggest global supplier, were ordered off the market in March 2010 after an investigation found many contained gel approved for use in products from computers to cookware, but not medical devices.
French authorities then sparked a global panic late last year by saying the implants should be surgically removed due to an unusually high rupture rate.
Pedro Del Medico, the director of Venezuela's association of private medical clinics, said his group was willing to negotiate if decisions are made based on scientific information since not all health experts say the implants are dangerous.
Some governments like Britain and Brazil recommended women check their implants, but did not necessarily advise removal.
Galaxia Medica, which imported PIP products into Venezuela, said it was open to dialogue but that it was not to blame.
"We want to help contribute to a solution to this problem, but from a legal perspective we don't think we have any responsibility in what happened," said Ruben Bretto, a spokesman for the company that sold the implants directly to doctors and to a pharmacy chain. "We also feel tricked, because we acquired a product that was well known internationally and certified."
If there is no deal on replacing the implants, Mr. Leon said ANAUCO will sue doctors and clinics for psychological and economic damages. He cited as precedent a ruling last month by a Spanish court that fined a surgeon and a private clinic €7,500 ($9,881.25) for giving women PIP implants without sufficient information.
In Venezuela, he said each case will carry a different price tag depending on the circumstances. But the surgeons, clinics and the distributor all say they are also innocent victims since they used products internationally certified as safe.
Surgeons in Italy are suing both PIP and TÜV Rheinland, claiming they are injured parties as well.
Lawsuits against local doctors and clinics and local health regulators that allowed the products to be imported could follow in other parts of Latin America. Led by Venezuela and Colombia, the region became PIP's top market, generating two-thirds of the company's sales.
In Argentina, some women have already been able to settle out of court to have the operating doctor's insurance pay for replacements.
Cut-rate plastic surgery is widespread in Venezuela, where many women from all economic classes take out loans to nip, tuck or boost different body parts in procedures that are sometimes even given away as raffle prizes.
Joli Canizales, a 32-year-old house cleaner, spent a big chunk of her salary on a breast augmentation in a back-room clinic seven years ago. The operation came at a discount, but was performed by an unqualified physician's assistant.
"He wasn't a doctor, he was more of a butcher," said Ms. Canizales, who is now experiencing daily pain after her PIP implants burst and leaked silicone into her body. "I am not wealthy, but I always had this dream to feel more beautiful. Now it's just a nightmare."
Unemployed after floods last year left her homeless, Ms. Canizales says she cannot afford another operation. A group organizing the victims singled out her and some 50 other women as the most severe cases and have asked lawmakers to set aside funds for their operations.
After Venezuelan President Hugo Chavez railed against "capitalist advertising" for spurring Venezuela's plastic surgery craze, heath ministry officials offered to remove the PIP implants for free in the socialist government's public hospitals.
Ms. Canizales says she tried that route, but the hospital turned her away since her case was not an emergency.
The public health system is ill-equipped to deal with the scale of the problem, said Nakary Fleming, a 32-year-old lawyer, who is helping to organize the affected women. "In many places they don't even have gauze."
Ms. Fleming said another issue is the government's refusal to put in new implants. "No one wants to be left with nothing. Their breasts are deformed, their skin is stretched out, they look like old women...That affects social life, self-esteem."
Many women who can afford it are flocking to private doctors who can give them new, safer replacement implants.
Plastic surgeon Daniel Slobodianik has been swamped with requests after he announced via Facebook and Twitter that he would waive his operating fees to replace PIP implants.
"I am booked through August, and that's doing at least two removals every day," Dr. Slobodianik said during a brief interview between a steady stream of women visiting his small office at a shopping mall in an upscale Caracas district.
He says at least 40% of his patients have damaged implants. "I've never seen so many ruptures. Some of them are completely pulverized," he said, showing a photo on his iPhone of a mushy, formless blob he removed recently as an example.
Beauty is such a lucrative industry in Venezuela that the country spawned its own private beauty queen factory—the Miss Venezuela Organization—to train pageant hopefuls on everything from the perfect runway sashay to public speaking, with a price tag of up to $70,000 per contestant.
Richard Linares, a personal trainer for the organization, scoffed at the idea that the PIP scandal would put Venezuelan women off cosmetic surgery that is so popular that some teenage girls receive implants as a birthday present from their parents.
"In Venezuela, plastic surgery is not just a fad. It's a way of life," he said.
FRANKFURT, Germany (Reuters)—Germany’s medical safety board on Friday advised women with potentially defective breast implants to consult their doctors for checks but stopped short of recommending their removal.