France to Pay for PIP Silicone Breast Implant Removal, As Cancer Fears Go Global

French health officials said Wednesday that the government would cover the cost of removing faulty silicone breast implants made by Poly Implant Prosthese (PIP) for some of the thousands of women there who have received them. Meanwhile, fears that PIP breast implants can rupture or cause a rare form of cancer have spread to other countries where the devices were sold.

As we reported previously, the PIP implants were among the cheapest on the market, and are more fragile than other silicone breast implants. PIP Implants were pulled from the market last year, and the company became the subject of a criminal probe in France after it was learned cheaper industrial silicone, rather than medical-grade silicone, was used in the devices.

Some 30,000 women in France received PIP breast implants before they were recalled. The French health and safety agency AFSSAPS has received 1,000 reports of PIP breast implants rupturing. The devices have been implicated in the death of one woman who developed a rare form of cancer called anaplastic large cell lymphoma (ALCL) following the rupture of her implant. While a definitive link to the cancer has not been found yet, a total of eight have been reported among French women with the PIP breast implants.

More than 2,000 lawsuits have been filed in France since the PIP implants were recalled. PIP shut down last year, after the silicone breast implants were pulled from the market.

Some doctors in France have said women may be able to prevent cancer by having the implants removed, and have called on the French government to pay for removal procedures.

According to a report from CNN, a committee made up of representatives of several French health agencies was set up December 14 to discuss PIP implants, and is scheduled to meet on Friday. The French Ministry of Health said on Wednesday that it will recommend that the government cover the costs of removing the PIP breast implants when the committee meets. However, only women who received PIP implants for reconstructive surgery will be eligible for reimbursement.

Meanwhile, The New York Times is reporting that the PIP silicone breast implants were also implanted in hundreds of thousands of women in half-a-dozen European and Latin American countries. The cancer fears have spread beyond France, and regulators in those countries are trying to ease women’s’ fears about their PIP implants.

In Brazil, the National Agency of Sanitary Vigilance prohibited the importation and use of the implants in April 2010, after concerns about their safety emerged in France. The director of the Brazilian Society of Plastic Surgery told the Times that it has not received any “significant reports of either ruptures or rejections or even cancer” related to the PIP silicone breast implants.

Chile’s Public Health Institute asked the estimated 1,000 or so women thought to have implants from PIP to contact their doctors so the devices could be removed if ruptures occurred, the Times said. If the implants are still intact, women there have been told to undergo annual checks to monitor their condition.

Alexandra Blachere, the leader of a French PIP implant patient group, told Reuters that women from Italy and Spain had been in touch with her with worries about their implants, and she’d seen reports of problems in other countries, including in Venezuela and Brazil.

“It’s not just France that’s concerned. We’re looking at 300,000 to 400,000 potential victims in the world,” Blachere said.

In the United Kingdom (U.K.), where some 40,000 have received the devices, the British Medicines and Healthcare Products Regulatory Agency (MHRA) said its testing had found no evidence to suggest that women should have them removed. According to a statement from the agency, it has not received any reports of ALCL linked with breast implants. MHRA advised women who were concerned about their implants, or who think their devices may have ruptured, to contact their doctor.

About 4,500 women in Australia who received the PIP breast implants are being advised to monitor their devices. According to a report by the Australian, the Therapeutic Goods Administration says it has received reports of 39 devices rupturing inside Australian women since they came on the market seven years ago. No cases of cancer have been reported among women with the implants.

According to CNN, PIP never sought approval from the U.S. Food & Drug Administration (FDA) to sell the silicone breast implants in the U.S., so they were never available to women here. In March 2000, the FDA decided not to approve saline PIP implants for sale here.

This entry was posted in Breast Implants, Defective Medical Devices. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.