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Breast implant fiasco sends up alarms Add to ...

When Vanessa Halstead was starting out, struggling to land modelling jobs, the solution seemed simple enough: a pair of $6,000 double D silicone implants to augment her B-sized breasts.

She canvassed friends, settled on SurgiCare, a reputable British clinic, and ensured her surgeon was certified by the presiding medical boards.

“The only thing I couldn’t ever find out was what kind of implants would be used. All the clinics said was they were the best implants in the world,” said Ms. Halstead, now a 29-year-old actress who plays a cocktail waitress in the British soap, Coronation Street.

Last October, after a spray tan, she noticed her right breast was swollen. On her morning run the next day, she was seized with pain. A subsequent ultrasound revealed one of her implants had ruptured, thrusting her in a global health scare that culminated Friday with the arrest of the founder of a French firm that manufactured them.

The case revolving around Jean-Claude Mas, the 72-year-old head of Poly Implant Prothèse (PIP), has raised profound questions about the regulations surrounding the manufacture and regulation of breast implants. Experts say North America has stronger regulatory practices than Europe and South America.

French authorities have placed Mr. Mas under house arrest after charging him with causing bodily harm. Investigators questioned him for hours before releasing him on €100,000 bail, barring him from leaving the country.

He will face a separate fraud trial over the manufacture of the implants, but will not be investigated on a manslaughter charge stemming from the 2010 cancer death of a French woman with PIP implants.

The company – once the world’s third-largest breast-implant manufacturer – was shut down in March, 2010, after regulators found out its implants were made of non-medical silicone gel, a mixture Mr. Mas allegedly used to trim costs. Instead of standard gel, investigators say PIP’s gel included industrial-grade silicone typically used to manufacture mattresses.

The implants were not sold in Canada or the United States. However, PIP’s website said it had exported implants to more than 60 other countries.

“I think North America’s been very much ahead of the curve and has been very careful about regulatory issues,” said Mitch Brown, a plastic surgeon at Women’s College Hospital in Toronto.

Trevor Born, another prominent Toronto plastic surgeon, agrees. “It’s tougher to get a product – whether it’s an implant or a device – to market with approval. There are more requirements for clinical study and unbiased data,” he said.

Two months after Ms. Halstead’s ultrasound, the French government advised 30,000 women to have their PIP implants removed, spurred by health officials’ warnings that they were more susceptible to rupture than other implants.

According to official estimates, more than 42,000 women in Britain received the implants, more than 30,000 in France, 9,000 in Australia and 4,000 in Italy. Nearly 25,000 of the implants were sold in Brazil.

British and Brazilian health officials have stopped short of asking women to remove their PIP implants, but have requested they visit their doctor for checks.

Medical-grade silicone is inert, but the potential health risks posed by exposure to industrial-grade silicone is unclear.

“There have been many generations of implants and most of them that had liquid silicone fill [as opposed to gel] probably posed more risk in local tissue inflammation, and then there are rare cases where silicone can travel,” Dr. Born said.

When Ms. Halstead had her implants removed, the ruptured one from her right breast was a yellowed, gooey mess.

“The silicone didn’t leak into my blood stream or my lymph glands or anything. It stayed in its capsule so I was lucky in that respect,” she said.

She set up a website to advocate for other women with PIP implants. In the last week, she said she has been contacted by 30 to 40 women a day.

“It’s great that [Mr. Mas] was arrested, but now he’s enjoying life on bail. The question I still have is how he hid for so long from the regulators in the first place,” she said.

“His arrest has to be seen as just a first step. There are so many of us that have been to hell and back through no fault of their own,” she added.

She hasn’t decided whether she will pursue legal action of her own. Despite her ordeal, she remains an advocate of cosmetic surgery.

After having her implants taken out, Ms. Halstead worried her breasts would be baggy and susceptible to infection.

“In the end, I decided to have new ones put in,” she said.

With reports from Associated Press

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