Boxes containing silicone gel breast implants manufactured by now-defunct French company Poly Implant Prothese (PIP) inside an abandoned PIP building in La Seyne-sur-Mer near Toulon, December 28 2011.
At least 1500 women in Bulgaria have breast implants made by France’s Poly Implant Prothese (PIP), the firm that went bankrupt in March 2010 and whose implants are the subject of worldwide concern because of their higher-than-average risk of dangerous ruptures.
The French health ministry says women with PIP implants do not have a higher risk of cancer than women with implants made by other companies, but says there are "well-established risks of ruptures" the BBC reported earlier.
The UK medicines watchdog, the Medicines and Healthcare products Regulatory Authority said that France had reported rupture rates of about five per cent for PIP implants, compared with one per cent in the UK.
A report by Bulgarian television station bTV said that unlike France, where patients had been advised to replace the implants, plastic surgeons in Bulgaria advised women to monitor the condition of the implants with regular ultrasound examinations, at intervals of about six months.
Consultant Dr Strahil Efremov said that there was no reason for panic.
Removal of breast implants costs about 1000 leva (about 500 euro). Removal and replacement must be paid for by the patient.
Reportedly, about 10 000 Bulgarian women have silicone breast implants.
BTV said that because of doctor confidentiality and concealment of profits by some clinics, there were no precise statistics on how many women have implants.
Some of the operations are performed by physicians who are not members of the Association of Plastic Surgeons and cannot be traced.
In some cases, gynaecologists were operating as plastic surgeons and placing breast implants. There was no law against this, bTV said.
New legislative measures on cosmetic surgery would be ready by the end of 2012, the report said.
PIP used industrial-grade silicone instead of medical grade silicone in its implants, which reportedly have been placed surgically in about 300 000 women worldwide.
Bulgarian National Television quoted Bulgaria’s Health Ministry as saying that PIP’s documentation had been in order and the products had borne the European Community CE mark.
It was, however, unclear how France had permitted the issuing of a certificate to a product with poor quality silicone that had spread around the world.