FRANKFURT (Reuters) - Germany’s medical safety board on Friday advised women with potentially defective breast implants to consult their doctors for a checks but stopped short of recommending their removal.
Earlier, the French government recommended 30,000 women to seek removal of breast implants, made by the now-defunct Poly Implant Prothese SA (PIP), which is accused of using industrial-grade silicone.
The implants are at risk of rupturing and could cause inflammation and irritation. The French government said there was no evidence the product raised the risk of cancer.
A spokesman for Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said: “We recommend affected women consult their physicians to make an individual risk assessment. Removal could be the result of such an assessment but there is no blanket recommendation to have surgery.”
Nineteen women have suffered ruptured PIP implants in the country, according to reports from German clinics and doctors.
“We have been warning of the rupture risk in PIP products since April 2010. There is so far no evidence of any causal link to cancer,” the spokesman added.
In France, public healthcare funds will be used to finance the removals but new implants will only be paid for in cases where the initial implant was inserted for medical reasons.
In Germany by contrast statutory medical insurers (GKV) would only fund the removal if the implant was for medical reasons, otherwise they would recoup part of the cost from the patient, a spokesman said.
“The law in this case speaks of an ‘appropriate rate’ that the patient has to pay out of her own pocket. It is up to the individual statutory insurance company to interpret what ‘appropriate’ is, the spokesman said.
As many as 300,000 women worldwide may have received PIP implants, which were exported in particularly large quantities to Latin American countries such as Brazil and Argentina, and Western European markets such as Britain, Germany, Spain and Italy.
Founded in 1991, PIP was for a time the world’s number three maker of implants.
Reporting by Ludwig Burger; writing by Alexandra Hudson