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CARACAS (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 Prothese (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’s 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.

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.

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Special report on PIP: http://link.reuters.com/naj46s

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PIP went bankrupt, but Leon said?the lawsuits the Venezuelan women want to join in France are also?targeting German certification company?TUV?Rheinland for compensation. TUV 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.

CHEAP OPERATIONS

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 which 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, 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 Euros 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?TUV 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 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, 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 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.

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.”

WOMEN WANT REPLACEMENTS

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,” 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 percent 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.

(Editing by Daniel Wallis and Kieran Murray)

Source: http://news.yahoo.com/venezuelans-threaten-mass-lawsuits-faulty-breast-implants-170224204.html

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In this photo taken on Jan. 26, 2012, plastic surgeon Dr. Ignacio Sousa holds two PIP breast implants after they were removed from a patient at a clinic in Caracas, Venezuela. The yellow implant at right is broken. Thousands of women throughout Latin America are consulting their doctors, fearing health risks due to faulty silicone implants made by the now-defunct French company Poly Implant Prothese, or PIP. The scandal has hit Venezuela particularly hard. About 16,000 Venezuelans have the PIP implants, making the country the per-capita leader in Latin America. (AP Photo/Ariana Cubillos)

In this photo taken on Jan. 26, 2012, plastic surgeon Dr. Ignacio Sousa holds two PIP breast implants after they were removed from a patient at a clinic in Caracas, Venezuela. The yellow implant at right is broken. Thousands of women throughout Latin America are consulting their doctors, fearing health risks due to faulty silicone implants made by the now-defunct French company Poly Implant Prothese, or PIP. The scandal has hit Venezuela particularly hard. About 16,000 Venezuelans have the PIP implants, making the country the per-capita leader in Latin America. (AP Photo/Ariana Cubillos)

In this photo taken on Jan. 26, 2012, a plastic surgeon holds a broken PIP breast implant after it was removed from a patient at a clinic in Caracas, Venezuela. Thousands of women throughout Latin America are consulting their doctors, fearing health risks due to faulty silicone implants made by the now-defunct French company Poly Implant Prothese, or PIP. The scandal has hit Venezuela particularly hard. About 16,000 Venezuelans have the PIP implants, making the country the per-capita leader in Latin America. (AP Photo/Ariana Cubillos)

In this photo taken on Jan. 24, 2012, Sania Arroyo, 33, sits next to the two PIP breast implants that she had removed, during an interview in Caracas, Venezuela. The yellow implant at left is broken. Thousands of women throughout Latin America are consulting their doctors, fearing health risks due to faulty silicone implants made by the now-defunct French company Poly Implant Prothese, or PIP. The scandal has hit Venezuela particularly hard. About 16,000 Venezuelans have the PIP implants, making the country the per-capita leader in Latin America. (AP Photo/Ariana Cubillos)

In this photo taken on Jan. 24, 2012, Sania Arroyo, 33, shows the two PIP breast implants she had removed in Caracas, Venezuela. The yellow implant at left is broken and sits in a case. Thousands of women throughout Latin America are consulting their doctors, fearing health risks due to faulty silicone implants made by the now-defunct French company Poly Implant Prothese, or PIP. The scandal has hit Venezuela particularly hard. About 16,000 Venezuelans have the PIP implants, making the country the per-capita leader in Latin America. (AP Photo/Ariana Cubillos)

CARACAS, Venezuela (AP) ? The office of plastic surgeon Ignacio Sousa is so packed that women are lined up outside the door. College students in their 20s, housewives in their 40s, middle-class office workers: nearly all are fearful that their breast implants may be leaking.

Thousands of women worldwide are consulting their doctors about health concerns that have sprung up since December due to faulty silicone breast implants made by the now-defunct French company Poly Implant Prothese, or PIP. In some cases, the implants filled with industrial-grade silicone have split open, prompting growing demand for their removal.

“It’s like a snowball,” said Sousa, who has been receiving dozens of patients every day since the news broke that French authorities recommended the implants be removed.

The scandal has hit beauty-obsessed Venezuela particularly hard. An estimated 16,000 Venezuelans have the implants, one of the highest figures among Latin American countries, along with much-larger Brazil, where about 20,000 women have PIP-made implants.

Breast enlargement surgery is common in Venezuela and has grown in popularity in recent years among middle-class women, thanks in part to low-interest loans offered by private clinics for the operations.

The PIP brand was used frequently until the implants were pulled from the market in 2010.

Like many of those affected in Venezuela, Sania Arroyo has struggled with the mounting medical bills. The 33-year-old bank employee and single mother managed to save about 20,000 bolivars, or $4,600, for surgery to replace the implants in January, scraping together nearly four times what she paid to have them inserted in 2007.

She suspected a problem with the implants when she felt a tingling pain under her left breast, and an ultrasound exam confirmed one had ruptured and was leaking silicone into her body.

She said the replacement implants feel more comfortable, but she’s still apprehensive about them.

“I feel so much better now, although I still have the fear something similar could happen again,” Arroyo said, holding a plastic case containing the ruptured implant and the yellowish silicone that leaked out.

PIP’s silicone gel is transparent, but doctors say the substance often turns yellow when it comes in contact with body tissues.

Arroyo is one of 495 Venezuelans who are suing companies that sold the implants, demanding payment of medical costs.

Venezuela’s government offered to remove the implants for free, but many women say they won’t take up the offer because they prefer to have new implants and the government won’t pay for them.

French authorities say an estimated 300,000 women have the implants worldwide, including more than 42,000 in Britain, more than 30,000 in France, 9,000 in Australia and 4,000 in Italy.

The implants were never approved for sale in the United States, but tens of thousands of pairs were sold in Latin America. In Colombia, for instance, the association of plastic surgeons says about 14,000 pairs of PIP implants were sold.

On a per-capita basis, Venezuela appears to lead Latin America in the number of breast implants. That’s no surprise to most people in the country, where beauty pageants are a source of national pride and where some teenagers receive implants as birthday presents. Middle-class women sometimes set aside large portions of their salaries for the surgery.

An estimated 35,000 to 40,000 women undergo breast enlargement surgeries in Venezuela each year, and doctors say the numbers have been rising.

“Terror has certainly gripped patients who have the implants, but I don’t believe the desire for breast enlargement surgery is going to diminish,” said Gabriel Obayi, a surgeon who has been answering many emails from women concerned about health risks.

Like most surgeons in Venezuela, Obayi recommends that PIP implants eventually be removed but advises that surgery is not urgent in most cases.

Regardless of the brand, breast implants are known to break down over time and rupture in some cases.

The U.S. Food and Drug Administration banned silicone-gel type implants in 1992 amid fears they might cause cancer, lupus and other diseases. But in 2006 the agency returned the implants to the U.S. market after most studies failed to find a link between silicone breast implants and disease.

The FDA began an investigation last year into a possible link between implants and a very rare form of cancer, known as anaplastic large cell lymphoma. The agency said it had learned of about 60 cases of the disease worldwide among women with implants.

France’s Health Safety Agency has said the suspect PIP implants appear to be more rupture-prone than other types, but officials have not specified why.

French health authorities have said they don’t know enough about the health effects of the industrial-grade silicone in the faulty implants, and have recommended that women get them removed after the implants ruptured in more than 1,000 cases. The government has agreed to pay for the procedure.

Investigators in France say PIP sought to save money by using industrial silicone rather than the medical-grade variety.

Last week, French authorities filed preliminary charges against PIP’s founder, Jean-Claude Mas, who according to his lawyer is under investigation for “involuntary injury.” His company went into bankruptcy proceedings shortly after the government in 2010 pulled the implants from the market.

The scandal has left many women asking about the risks they may face, and doctors so far have limited answers.

“We don’t know, neither in Venezuela nor Latin America, what percentage of PIP implants rupture,” said Dr. Carlos Nieto, a surgeon and board member of the Venezuelan Society of Plastic and Reconstructive Surgery.

It’s also unclear how many women have had the implants removed so far.

In Argentina, about 300 women are negotiating with private clinics and a local distributor, Pro Estetica, demanding the defective implants be replaced for free, said attorney Virgina Luna, who represents the group.

Gabriela Febres, a 30-year-old financial analyst in Caracas, has joined the legal case against Venezuelan distributors. She suspects she needs to have surgery soon because her right breast has been hurting for weeks.

“This affects you in so many ways: your job, your finances and your psychological state,” Febres said. “The uncertainty is the worst.”

____

Associated Press writers Almudena Calatrava in Buenos Aires, Argentina, Stan Lehman in Sao Paulo, Brazil, Cesar Garcia in Bogota, Colombia, and Angela Charlton and Jamey Keaten in Paris, as well as AP Medical Writer Maria Cheng in London contributed to this report.

___

Christopher Toothaker on Twitter: http://twitter.com/ctoothaker

Associated Press

Source: http://hosted2.ap.org/APDEFAULT/cae69a7523db45408eeb2b3a98c0c9c5/Article_2012-01-31-LT-Latin-America-Breast-Implants/id-b30d8c07b2cc45549f7bb2f70c63b43e

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