A prominent British surgeon says women who received defective silicone breast implants made by Poly Implant Prothese (PIP) of France should have them removed because of the risk that they could rupture. According to the BBC, Tim Goodacre says the rate of PIP silicone breast implant ruptures may be “quite out of the ordinary.”
PIP silicone breast implants, which were already among the cheapest and most fragile on the market, were recalled last year after it was learned that they contained industrial, rather than medical grade, silicone. Late last year, the same breast implants sparked cancer fears in France after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. At least eight cases of ALCL have been reported among French women with the PIP implants.
French health authorities have advised some 30,000 women there who had received the PIP silicone breast implants to have them removed because of their risk of rupture, but have been unable to definitively link them to cancer. PIP has since gone out of business, and is the subject of a criminal investigation in France.
Before the recall, PIP produced about 100,000 silicone breast implants a year. Fears about ruptures and cancer have spread to many of the other countries where they were sold, including Brazil, Argentina, Britain, Germany, Spain, Italy, and Israel. More than 2,000 women in France have filed legal claims over the PIP breast implants, while 250 implant recipients in Britain have done the same.
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.
According to the recent BBC report, British regulators have put the rupture rate there at about 1%. But a private clinic, Transform, believes it could be up to 7%. U.K. Health Secretary Andrew Lansley ordered an inquiry after Transform came forward with its data. Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), is part of the panel that will advise the U.K. on the PIP implants.
“Good implants put in by reputable people have an extraordinarily low failure rate, so this is something quite out of the ordinary,” Goodacre told the BBC.
While Goodacre did not think there was any risk of cancer as a result of the faulty implants, he was still advising what he called removal on a “staged basis,” the BBC said.
“If you believe a device is faulty in your car or any other object you buy you would want to have that replaced on a staged basis,” he said.
The PIP silicone breast implants were never approved for sale in the U.S. However, PIP did sell roughly 35,000 saline filled implants in the U.S. between 1996 and 2000, and those were the subject of a U.S. Food & Drug Administration (FDA) warning letter in 2000. The PIP saline breast implants are the subject of product liability lawsuits in the U.S. filed by women who claim they deflated after several years.
The saline devices never underwent human tests, thanks to the FDA’s 510(k) approval process. But due to concerns about possible complications such as infections and rupturing, the agency finally required all implant companies to submit formal applications for saline breast implants in 2000. PIP’s application was ultimately rejected by the FDA.