Bursting implants widely unreported in Sweden

The Swedish Medical Products Agency (Läkemedelsverket) does not know how many of the French PIP breast implants used by an estimated 4,000 Swedish women have burst. Despite legislative demands, beauty clinics often fail in reporting potential side effects.

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“There are many cases that go unreported and there is no doubt that it would be favourable for patient safety if the clinics would follow the law and make the proper reports,“ said Gert Bruse of the Medical Products Agency to news agency TT.

Some 5,000 implants from the now bankrupt French company PIP, or Poly Implant Prothèse, were sold in Sweden before news that they were faulty leaked out.

"They were sold at nine different clinics in Sweden," Bruse told the Dagens Nyheter (DN) newspaper in December.

Sweden banned the company's implants in March 2010, along with many other European countries, when it was discovered that substandard silicone gel was causing unusually many implants to burst.

After the discovery, the Medical Products Agency recommended that Swedish women who had the implant have them removed.

"We've had cases where the implants have burst in Sweden, but it's fewer than in France in relation to how many women have these implants in both countries," said Bruse to DN.

However, many cases of faulty implants go unreported in Sweden, due to clinics failing to report any side effects to the Medical Products Agency.

According to Ulf Samuelsson, chairman of the Swedish Society for Aesthetic Plastic Surgery (Svensk förening för estetisk plastikkirurgi), the clinics are failing to make the reports due to an eagerness to uphold patient confidentiality and due to lacking information from the National Board of Health and Safety (Socialstyrelsen).

“There is great concern among our members that confidentiality can’t be guaranteed. Further, the dialogue with the National Board of Health and Safety hasn’t always worked as well as it should, “ Samuelsson told TT.

“There is a definite lack of information.”

Samuelsson flagged for the need of an implant register, something that he said had been discussed very a long period of time.

According to Samuelsson, another reason that many clinics fail to report potential side effects, is that a breast augmentation isn’t considered major surgery.

“There is probably a measure of civil disobedience there,” Samuelsson told TT.