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, saying that they split more often than other brands, according to a report by Lord Howe, U.K.’s health minister, wrote The Telegraph. 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.
Surgeons, not named in the report, offered to carry out audits of their own records to help expedite correction of the widespread issue. Instead, the MHRA contacted a German firm that assessed the PIP implant. That firm, said The Telegraph, rendered a so-called “CE ‘kite’ mark,” with assurances, saying, “While it is possible that the MHRA could have derived further helpful information had they followed up the offers made by individual surgeons, it seems unlikely that any further information would have done other than to reinforce the course of action the MHRA subsequently took in contacting the notified body about their concerns with PIP implants.”
Meanwhile, about 50,000 woman in the U.K have been implanted with the defective device, most from private clinics. In France, said The Telegraph, authorities recommended that women have the implants removed. In Britain, however, women were told to speak with the clinic they used, but there was no need to remove in tact implants. The National Health System (NHS) also announced it would remove the PIP implants at cost or for free should private clinics refuse to, said The Telegraph.
The MHRA stated it required proof of a problem with the PIP implants before investigating the matter, to avoid adverse market effects. Consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah, disagreed, arguing that “Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis. This is an opportunity for the Department of Health to get it right, and put the necessary systems and checks in place to avoid a repeat fiasco. Clearly changes are also needed at European level of the CE marking process.”
According to Lord Howe, “It must be emphasized that this case was one of deliberate fraud by the PIP manufacturer which purposefully misled European regulators. Regulation alone cannot prevent fraudulent activity such as this. But serious lessons must be learned from this scandal.”
As we’ve written, at least 3,000 alleged victims have filed complaints and about 300,000 PIP implants have been sold worldwide. PIP admitted it used unapproved silicone in the implants, brushing off fears of a health risk. In the U.S., women were warned about the PIP implants; in the Netherlands, regulators advised women to have the implants removed; in Germany, women were advised to have the devices removed; in Iceland, the government said it would cover patient monitoring and costs for damaged device removal; and, in Brazil, health authorities said the government will fine private insurers that refuse to pay for removal and replacement of faulty PIP implants. Women in several countries, including France, Iceland, Britain, and Argentina, have filed, or are planning to file, lawsuits over the implants.
PIP silicone breast implants were recalled in 2010 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.
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.