Some 5,000 implants from the now bankrupt company PIP, or Poly Implant Prothèse, have already been sold in Sweden, corresponding to an estimated 2,500 Swedish women with the controversial implants.
“They were sold at nine different clinics in Sweden,” Gert Bruse of the Swedish Medical Products Agency (Läkemedelsverket) told the Dagens Nyheter (DN) newspaper this week.
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.
“Implants shouldn’t burst and they shouldn’t have an irritating effect that spreads throughout the body. What this company has done is criminal, simply put.”
Now worried voices have expressed concern that PIP’s implants also increase the risk of breast cancer, after eight cases of breast tumours have been uncovered in women after removing the implants.
It’s still unclear whether the tumours were caused by the implants or not.
French authorities are now recommending women bearing implants from PIP have them removed, although the country’s health minister Xavier Bertrand pointed out that there was no rush.
The recommendation was described as a “preventative measure”, and Bertrand underlined that women with implants from PIP do not run a higher risk of cancer than do women with other implant brands.
The Swedish Medical Products Agency is unwilling to comment on the French recommendation to surgically remove these implants.
“We haven’t received any official data we can take a stand on yet. I’m going to go and check if there’s a misplaced message anywhere here, but I don’t think so. It’s hard for us to comment on this right now,” Bruse told news agency TT.
As early as 2009, French authorities discovered an increased tendency towards leakage from breast implants made by PIP. It was soon unveiled that the company had used another type of gel than authorities had given their approval for.
According to news agency AFP, the company chose to replace the medical-grade silicone in its implants with industrial-strength material when faced with financial struggles.
The Swedish Medical Products Agency banned all further marketing of the implants
the very next day, and the Swedish authority made all nine clinics who provide breast augmentation surgery to offer affected patients consultation.
In France, implants were analysed last year, and results showed that the gel used contains tissue toxic substances, in other words poisonous substances which could possibly increase the risk of cancer.
PIP’s implants have only been used in cosmetic breast augmentation surgery, not in reconstructive surgery.