- Associated Press - Tuesday, January 31, 2012

CARACAS, VENEZUELA (AP) - A line snakes out of the plastic surgeon’s office as women wait to find out if their breast implants have ruptured and how soon they can have them removed.

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. In some cases, the implants made with industrial-grade silicone have split open, and that possibility is prompting many women to replace them.

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

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. Breast enlargement surgery is common in the country, and the PIP brand was used frequently until the implants were pulled from the market in 2010.

More than 4,000 Venezuelan women have banded together to join a Facebook page dedicated to those with the implants.

When Sania Arroyo began to feel a tingling pain under her left breast, she suspected a problem with her implants. An ultrasound exam confirmed one had ruptured and silicone was leaking into her body.

The 33-year-old single mother and bank employee struggled to save about $5,000 to pay for the surgery in January, and says the new brand has made her more comfortable, but she still feels apprehensive about the safety of her replacements.

“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 don’t plan to take up the offer because they prefer to have new implants and the government won’t pay for them.

It’s not clear exactly how many women in Latin America have PIP implants. But the number is in the tens of thousands. French authorities say an estimated 300,000 women have the implants worldwide, though they were not sold in the United States.

The Brazilian Society of Plastic Surgeons says about 20,000 women in that country have PIP implants or other defective implants sold by the Dutch company Rofil Medical Nederland BV. In Colombia, the country’s association of plastic surgeons says about 14,000 pairs of PIP implants were sold.

Less-populous Venezuela has more cases than other countries on a per-capita basis. That’s no surprise to most people in the country, where beauty pageants are a source of national pride and cosmetic surgery is widely accepted.

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.

France’s Health Safety Agency has said one type of implants made by PIP appear to be more rupture-prone than others. French investigators say PIP sought to save money by using industrial silicone, the potential risks of which are not yet clear.

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.”

Debate over the potential health risks of silicone breast implants prompted the U.S. Food and Drug Administration to launch an investigation last year into a possible link between implants and a very rare form of cancer.

The FDA asked American doctors to report all cases of the cancer, known as anaplastic large cell lymphoma. Last year, the agency said it had learned of about 60 cases of the disease worldwide, among the estimated 5 million to 10 million women with implants.

The International Agency for Research on Cancer, which is part of the World Health Organization, has said silicone breast implants are “not classifiable” as to whether or not they cause cancer.

The FDA banned the silicone-gel type in 1992 amid fears it 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.

As for the PIP implants, French authorities have recommended that women in the country get them removed after more than 1,000 ruptures, and agreed to pay for the procedure.

“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 in Latin America 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. If an agreement cannot be reached, Luna said, the women plan to sue.

The Venezuelan surgeon Sousa said he had trusted in the PIP brand for years until 2009, when three patients came to him with implants that had split open.

Many doctors in Venezuela have been telling their patients they don’t need to replace their implants unless they have ruptured.

Gabriela Febres, a 30-year-old financial analyst, 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 Paolo, 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: https://twitter.com/ctoothaker



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