Though German officials have previously acknowledged that implants made by PIP could be dangerous and had resulted in 19 known ruptures, they revealed Wednesday that the number of reported cases was growing.
On the ZDF television network’s Morgenmagazin, BfArM’s president Walter Schwerdtfeger warned women with PIP implants to immediately visit their doctors.
“We definitely advise an operation,” he said.
French authorities first issued warnings about PIP in December after studies in France showed that one in 30 implants sold by the now-bankrupt company broke because cheap silicone was used.
Panic over the implants has since spread internationally, although German authorities have been slower than their neighbours to express alarm.
Schwerdtfeger was forced to defend his agency’s response to the growing crisis, saying that doctors had only recently reported the full extent of the implants’ silicone seepage. Now, it was clear, he said, that the silicone could leech into surrounding breast tissue, even if the implant seems intact.
A spokesman for BfArM said German doctors started to report problems on January 2 and that just four days later, BfArM recommended their removal.
BfArM did not immediately reply to a request from The Local about how many German women received PIP implants.
Authorities have previously said that no one knows because no central registries have been kept in Germany. Worldwide, between 400,000 and 500,000 people have the implants.
Schwerdtfeger told ZDF that he personally would be in favour of stronger controls to ensure implants meet international standards and suggested that factories making such things be subject to surprise inspections.
Jürgen Windeler, head of the Institute for Quality and Efficiency in Healthcare, which assesses drugs for the government, told Berlin’s Tageszeitung newspaper: “In the interest of patients, the market access requirements for medical devices in a high risk category such as pacemakers, knees, stents and hip replacements should, in principle be no different than those for pharmaceuticals.”