Tougher restrictions on cosmetic procedures are needed in the U.K. after at least 490 women had their breast implants removed because of a manufacturing scandal in France, an advisory panel told the government.
Botox, a wrinkle treatment sold by Allergan Inc., should only be given by certified professionals and fillers, calf and buttock implants should be classified as medical devices and regulated, the committee of nine experts said in a report today. The panel also said medical professionals should be registered and insured for liability and that all procedures and their outcomes be documented in a public database, as should any cosmetic medical device coming onto the market.
The panel, convened by the U.K. Department of Health, wants the government to adopt its recommendations before action by the European Commission, which is reviewing the way medical devices are approved in the region. The U.K. doesn’t expect the EC to introduce new policy before 2018. The regulations are “incoherent and frankly illogical,” said Bruce Keogh, medical director of the state-run National Health Service.
“Anyone, anywhere, can give a filler to anyone else,” Keogh, who led the review, told reporters at a press conference in London. “That is bizarre.”
Dermal fillers, which are injected into the face to fill out wrinkles and stimulate collagen production, should be classified as a prescription-only medical device, the panel said. In Europe, there are 190 types of fillers compared with only 14 in the U.S., where they are regulated as medical devices by the Food and Drug Administration, Keogh said.
Health Education England should establish training and qualifications for providers of non-surgical procedures such as Botox and fillers, and advertising promotions such as two-for- one specials that “trivialize” such procedures should be banned, Keogh said. Doctors should also receive records of their patients’ procedures and the Parliamentary and Health Service Ombudsman should be extended to take complaints, which would be public, the panel said.
The British Association of Aesthetic Plastic Surgeons favors creating training courses “more extensive than the many widely promoted weekend courses currently available” for non- surgical procedures, according to an April 1 statement.
The association wants laws tightened further so that procedures are done only by medical professionals. A group survey showed 69 percent of member surgeons saw complications with temporary fillers and almost half saw problems with semi- permanent or permanent fillers. Almost 9 out of 10 of those patients who had complications from permanent fillers needed corrective surgery or were deemed not treatable due to damage, the survey found.
The NHS had to cover the cost of removing breast implants made by Poly Implant Prothese SA following reports that they were leaking industrial-grade, non-medical gel. Had the PIP breast implants been registered and recipients tracked following their surgeries, problems would’ve been spotted much earlier, Keogh said. The panel recommends a National Breast and Cosmetic Implant Registry be set up within 12 months and that medical device manufacturers not be given advance notice of inspections, as was the case with PIP.
Jean-Claude Mas, PIP’s founder, continued to claim his products are “impeccable” in testimony during a fraud trial last week in France, where the company was based. More than 5,000 women have registered as victims in the case, according to Laurent Gaudon, a lawyer for 1,600 of them. Mas is on trial alongside four of his former colleagues.
Even with the negative publicity about the PIP implants, the U.K. market for cosmetic procedures will probably grow to 3.6 billion pounds ($5.5 billion) in 2015 from 2.3 billion pounds in 2010, the panel said. Keogh expects the recommendations to be considered in the parliamentary session that begins in November as there is a “political will” to pursue them, he said.
“The terrible stories that emerged from the PIP scandal revealed some shocking examples of extremely bad practices across the cosmetic interventions industry,” Health Minister Dan Poulter said in a statement. “The independent panel has made some far-reaching recommendations, the principles of which I agree with entirely. We will consider the report carefully and respond in detail in the summer.”
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