It’s more bad news for women who received breast enlargement or reconstruction with implants manufactured by French medical device maker Poly Implant Prothèse, as healthcare regulators in Sweden recommended this week that all patients undergo preventative removal of the devices, even those with no indications of problems with the implants.
Sweden’s Medical Products Agency and National Board of Health & Welfare advised yesterday that PIP implants, which were the subject of a high-impact European medical device and regulatory scandal, should be removed for "preventative" reasons.
The authorities estimated that about 4,000 Swedish women had received the implants, with the global figure close to 400,000.
Better safe than sorry
The PIP breast implants aren’t sufficiently durable, increasing their risk of rupture inside the body, the agencies warned. In addition certain PIP implants were found to contain a type of industrial-grade silicone that "may constitute a risk of serious inflammation in surrounding tissues.
"It is not possible, with any certainty, to identify which type of silicone is in any one woman’s PIP implants," according to the Swedish notice. "The authorities can see no immediate health risk associated with PIP implants, but, even if there are no symptoms caused by the PIP implants, it is recommended that they should be removed as a precautionary measure."
There was no apparent "immediate health risk" associated with the PIP implants, which were recalled in 2010 and banned from production after French regulators discovered that French regulators discovered that PIP had been sneaking substandard silicone into its breast implants for more than a decade.
Nonetheless, the substandard silicone could leak through the flimsy exterior of the PIP implants and result in inflammation in surrounding tissues. Data collected from clinics that have removed ruptured PIP implants suggest that there were signs of inflammation in about 1/3 of the cases,according to the notice.
Furthermore, signs of inflammation were found in women who had removed their implants preventively, before the implants had ruptured and before the patients had noticed any symptoms or irritation.
"Based on what we currently know, the Medical Products Agency and the National Board of Health and Welfare have assessed that PIP implants should be removed for preventative reasons, except in individual cases where there are medical reasons for not doing so," the regulators advised. "The controlled, preventative removal of PIP implants carries with it a lower risk than if they are removed once they have ruptured or once inflammation and/or swollen lymph nodes have developed.
The authorities advised that clinics contact all of their PIP patients and inform them of the updates and ask them to watch for signs of trouble with the implants, including changes in breast shape, lumps, pain or swelling.
A regulatory chain reaction
The French PIP scandal ignited a negative backlash that has resulted in a large-scale re-evaluation of the European CE Mark medical device review system. Poly Implant Prothèse was forced to recall 30,000 sets of breast implants after regulators discovered they were filled with substandard silicone, spurring calls for more stringent medtech review with additional checks and more transparency.
French authorities in December 2011 launched a criminal investigation of Poly Implant Prothèse after receiving 2,000 complaints from women who received the company’s breast implants. Investigations into the PIP implants by the French Society of Plastic Surgeons found them to have a higher rupture rate than implants with approved gels.
The PIP implants evaded notice despite inspections at manufacturing facilities because the company was given 10 days notice prior to the checks and workers concealed the problem silicone, according to reports. There were more than 100 product alerts issued by the Medicines & Healthcare Products Agency in 2011, but the agency can’t act unless a failure is reported.