Finnish woman undergoes surgery to replace potentially faulty breast implants

Suspect implants used by private Estonian clinic

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A Finnish woman who had been given PIP brand breast implants by a private Estonian beauty clinic about two months ago had the potentially harmful prosthetics surgically replaced on Friday.
      The new surgery took place after recent warnings that the French-made implants had an unacceptably high risk of leaking.
      It was also reported that in addition to the Poly Implant Prothèse silicone devices, there were similar potential problems with implants sold under another trade name, M-implant, of the Dutch company Rofil Medical.
     
Neither PIP nor M implants have been sold in Finland, but they have been offered by private cosmetic surgery clinics operating in Estonia, which do much business with Finnish patients.
      According to some estimates, about 200 Finnish women may have been given M implants in Estonia.
      Some websites of cosmetic surgery clinics in Tallinn continued to offer the M implants until shortly before Christmas, when France warned that PIP implants should be removed over safety concerns.
     
Dutch officials say that the M-implants have the same hazards as the PIP devices. However, it is possible that the M implants marketed in Estonia differ from the ones that were recently banned in The Netherlands and Germany.
      Juhani Rämö, head physician at the National Supervisory Authority for Welfare and Health (VALVIRA) says that the confusion stems from the existence of two different products under the same name.
      “The matter is confused because the brand name (M-implant) has not been changed even though it is now a different product”, Rämö says.
     
The notion of a new type of M-implant stems from a certificate of reliability granted by the Luxembourg licensing authority SNCH in the early part of 2010.
      The new types of M-impants have been manufactured by the Cyprus-registered Rofil Medical Implants, after Rofil Medical filed for bankruptcy in The Netherlands. The two companies have the same owner and CEO.
      The company has reportedly ordered breast implants from a factory in South Korea.
     
According to a press release put out by the manufacturer in November, the size and shape of the new M-implants are completely different from those of the banned PIP implants.
      However, the M-implants given to a woman interviewed by Helsingin Sanomat are essentially identical to the PIP devices – even the type codes are the same, says a plastic surgeon who has investigated the matter.
      The implants were replaced by new ones in an operation on Friday. After the operation the surgeon tested the M-implant that he had removed by squeezing it. It broke immediately.
     
“Why would a company start new manufacture with a trade name that is banned?” asks Professor Marita Eisenmann-Klein, chair of the International Confederation for Plastic, Reconstructive and Aesthetic Surgery (IPRAS).
      This is a question that might be put to Rofil Medical Implants, but the only contact information for the company is a street address in Cyprus.
      Cyprus’s Minister of Health Stavros Malas said in a Cypriot online publication on Friday that the Dutch company registered in Cyprus has apparently sold the controversial PIP breast implants under a new brand. Malas said that the company is under investigation for its “economic activities”.
     


Previously in HS International Edition:
  Finns’ favourite clinics in Estonia may have used problem silicone implants (23.12.2011)

Helsingin Sanomat