France May Call for Removal of Faulty Breast Implants in Response to Cancer Fears

France may soon warn women with a certain type of silicone breast implant to have them removed because of fears they might rupture or cause cancer. Such a warning would affect some 30,000 women there who have received the pre-filled silicone gel implants made by French company Poly Implant Prothese, or PIP.

As we’ve reported previously, PIP breast implants are among the cheapest on the market, and are fragile and more likely to leak than other brands. According to the Associated Press, the implants were pulled from the market last year, after it was learned that the company misreported the type of silicone they contain. Investigators suspect the device maker used cheaper industrial silicone instead of silicone meant for medical use in the implants.

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 form of cancer called anaplastic large cell lymphoma (ALCL) following the rupture of her implant. A total of eight cases of cancer have been reported among French women with the devices, but a definitive link to cancer has been found as of yet.

On Friday, French Health Ministry experts will meet in an attempt to set recommendations for women who have the PIP breast implants. What they ultimately recommend will depend in part guidance from the French National Cancer Institute, which is studying whether there are links between the implants and the cancer cases, the Associated Press said.

Some doctors have said women may be able to prevent cancer by having the implants removed. They have also called on the French government to pay for removal procedures, according to the Associated Press.

More than 2,000 lawsuits have been filed in France since the PIP implants were recalled last year.

The PIP breast implant problems have also raised alarms elsewhere. 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.

“The MHRA’s current advice to women with any type of breast implant continues to be that women who are concerned about their breasts or think that their implants may have ruptured, should seek clinical advice from their implanting surgeon,” the statement said.

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 the Australian, PIP was the world’s third-largest breast implant supplier before it was shut down last year, and about 300,000 women worldwide are estimated to have used the devices.

The PIP devices are not the only breast implants to raise cancer concerns in recent months. Earlier this year, the U.S. Food & Drug Administration (FDA) warned that 60 cases of ALCL had been reported among the 5 to 10 million patients with both silicone and saline breast implants. The cancer normally occurs in the breast in only 3 in 100 million women.

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


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