Brazilia’s health regulator Anvisa reported Friday that it has temporarily halted the production, sale, and use of breast implants produced by Silimed Indústria de Implantes Ltda.
Health officials said that they suspended the company’s CE certificate after a similar move was made by European authorities over contamination concerns. According to the results of an audit conducted by German health officials, the company’s implants seemed to be contaminated with unidentified particles.
In the wake of the report, Germans suspended the sale and use of the implants and so did the British Medicine and Healthcare Products Regulatory Agency shortly after being notified by its German counterpart.
Silimed implants were temporarily banned from marketing in Germany on Sept. 18.
Silimed Indústria de Implantes Ltda is South America’s major silicone implant maker and the third largest on the planet. Surgeons in Europe were urged by health officials to temporarily stop the use of the Brazilian breast implants. The ban also affected pectoral, penile and testicular implants made by Silimed. Patients who underwent surgery with the devices may be called to their doctors to assess their well-being.
The British Medicine and Healthcare Products Regulatory Agency acknowledged that there isn’t a patient that may have been affected by the contaminated implants. But if patients were affected health authorities do not know what to expect.
“For the moment, there has been no indication that these issues would pose a threat to the implanted person’s safety,”
the British agency recently told reporters.
Silimed replied and said that it has strictly followed all safety and quality rules and the presence of sterile particles do not pose a health threat for implanted patients. The company also said that it was collaborating with health agencies from Europe and Brazile to get to the bottom of the issue.
Silimed silicone implants are the most popular in Brazil, and are sold to over 75 countries worldwide.
Another silicone implant maker France-based Poly Implant Prothese had problems with authorities over safety issues. European authorities found that PIP implants had double the rupture rate of other device because the company used low-quality silicone. The company’s CEO was sentenced to jail for fraud.
So far, we don’t know whether Silimed implants may be as hazardous as PIP’s were, but experts believe that the number of patients affected by possibly faulty Brazilian implants may be considerably larger.
Image Source: Billingsplasticsurgery.com