The silicone breast implants, manufactured by France-based Poly Implant Prothèse, were banned from the Swedish market in March 2010 after French authorities discovered the gel used in the implants differed from the gel described in the implants’ technical specifications.
Further analysis revealed that the silicone gel used in the implants doesn’t meet the minimum standards for use in breast implants, according to Läkemedelsverket.
In addition, the gel can affect surrounding tissue if the implants crack or if the gel seeps through the implants’ membrane.
“The safety of the implants doesn’t meet the demands we have today,” said Gert Bruse of the agency’s medical technology division, in a statement.
Despite the warning, Swedish reality television star and model Marie Plösjö, 34, isn’t concerned about her implants which were first installed when she was 23.
“I’m not worried,” she told the Aftonbladet newspaper.
“I’m more worried about the never-ending set of procedures I have to subject my body to since I have to keep switching them out.”
French authorities have recommended that women carrying the Poly Implant Prothèse implants to contact a surgical clinic to discuss next steps. In addition, women with the implants are urged to undergo clinical evaluations, including an ultrasound examination, every six months.
Since 2001, an estimated 35,000 to 40,000 women around the world have been outfitted with the Poly Implant Prothèse implants.
While Läkemedelsverket currently estimate that around 5,000 women in Sweden may have the French implants, it cautions that exact figures are hard to come by because both the manufacturer and distributor of the implants have filed for bankruptcy.