London — Two of the United Kingdom’s leading private cosmetic surgery practices are calling for regulation reform following the Poly Implant Prothèse scandal, which left thousands of women with faulty silicone breast implants.
Harley Medical Group and Transform, which together used nearly 20,000 implants, said the failure of European regulators to spot faulty implants has caused financial and operating problems for the companies, BBC News reports.
“We have a duty of care to our patients and to date we have performed over 1,000 replacement surgeries, in the majority of cases at no cost to the patient,” Pierre Guillot, managing director of the Harley Medical Group, told the BBC. “We cannot finance the failures of the European regulatory system to have spotted a faulty implant for 12 consecutive years. You have to remember that these implants were CE marked. The CE marking means that the implants are not only safe, but that the medical devices are efficacious.”
The European Conformity (CE) mark ensures that products meet common standards required by the European Economic Area. Once a CE mark is awarded in one country, it is valid for all member nations.
The British government is currently reviewing the cosmetic surgery industry. The review will examine regulation, complaint resolution and clinical governance. An earlier report found no evidence that U.K. regulators had acted inappropriately and no evidence that regulators could have reasonably uncovered the faulty implants earlier.
The results of the current review are expected in 2013.
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