A U.K. inquiry finds that controversial PIP breast implants are six times likelier to rupture. At least 3,000 alleged victims have filed complaints about the implants; some 300,000 PIP implants have been sold worldwide.
The inquiry also found that, while there is a significantly increased rupture risk, the PIP brand implants to do not cause cancer, wrote the Daily Mail. Regardless, leading plastic surgeons say women should have the defective implants removed and attorneys have said that the official acknowledgement confirming that the implants are sub-standard allows women to now file lawsuits.
An expert panel—comprised of surgeons, ethicists, and statisticians—led by NHS medical director, Professor Sir Bruce Keogh, examined PIP implant safety and included specially commissioned tests on toxicity, said the Daily Mail. The contents of the French-manufactured PIP implants do not pose long-term health risks, said the panel.
Not everyone agrees. Nigel Mercer, former president of the British Association of Aesthetic Plastic Surgeons, said that while the industrial-grade filling does not kill cells, leaks can lead to large lumps that end up in the armpits. “Our position is that these are sub-standard implants and should not be in the human body. If a member of my family had them, I’d want them out,” Mercer told the Daily Mail.
We just wrote that U.K.’s medical regulator warned about the safety of PIP breast implants four years before the devices were recalled. It seems that, in 2006, surgeons contacted the Medicines and Healthcare products Regulatory Agency (MHRA) regarding concerns they had about PIP implants and saying that the faulty devices split more often than other brands, according to a report by Lord Howe, U.K.’s health minister. Yet, the defective implants remained on the market until March 2010 when French authorities discovered that silicone mattress filler gel, not approved materials, was fraudulently used in the implants.
Regulatory watchdogs never issued a warning over concerns that such a warning would cause an “unwarranted scare, which could have serious commercial implications,” according to the Daily Mail. The review, however, revealed that current regulation would never have been able to prevent the scandal, the result of “deliberate fraud,” by the device makers.
PIP admitted it used unapproved silicone in the implants, brushing off fears of a health risk and, 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.
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. Those devices are the subject of U.S. product liability lawsuits alleging they deflated after several years. The U.S. Food & Drug Administration (FDA) also cited the saline implants in a warning letter in 2000, before they were taken off the market here.