MHRA Suspends All Devices from Largest South American Silicone Implant Manufacturer

Regulatory NewsRegulatory News
| 23 September 2015 | By Zachary Brennan 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA), alongside EU member state regulators, announced Wednesday the suspension of all CE certificates for medical devices made by Brazilian manufacturer Silimed.

The suspension comes as a German notified body recently inspected one of the Brazilian manufacturing sites of Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, and found "the surfaces of some devices were contaminated with particles."

MHRA says its investigation with other European regulators is ongoing and it recommends that none of the company's devices should be implanted until further advice is issued.

"We emphasize that for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety," MHRA says. "EU health regulators have initiated testing of samples of products to establish if there are any health risks."

Silimed manufactures a catalogue of more than 5,000 implants for plastic surgery, bariatric surgery (including gastric bands and balloons), urology, general surgery and other invasive silicone devices in more than 75 countries.

The Silimed CE marks that are suspended are applied by the manufacturer and they mean that the device meets the relevant regulatory requirements, works properly when used as intended and is acceptably safe.

The suspensions in Europe could raise some eyebrows in the US, as the company claims to be the first non-American manufacturer whose silicone breast implants are authorized in the US by the Food and Drug Administration (FDA). The company operates two manufacturing facilities near Rio de Janeiro and employs about 600 people in the region.

The company did not respond to a request for comment by press time.

PIP Scandal

The Silimed suspensions immediately bring to mind the Poly Implant Prothese (PIP) breast implant scandal from 2011. The now-defunct PIP, a French manufacturer, ignited a mess of controversy over the safety of medical devices in the EU after the implants were found to have been manufactured to deficient standards.

At the time, the UK's MHRA removed the implants as a precautionary measure, though the UK's Department of Health (DOH) later cleared the implants of most serious concerns, saying there were no indications that they would adversely affect long-term human health.

MHRA Notice


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found