Regulatory Focus™ > News Articles > MHRA Calls for Continued Quarantine of Silimed Implants

MHRA Calls for Continued Quarantine of Silimed Implants

Posted 08 January 2016 | By Zachary Brennan 

MHRA Calls for Continued Quarantine of Silimed Implants

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday reiterated its call to quarantine implants manufactured by Brazil’s Silimed, saying it’s still trying to determine if there are potential health risks associated with particles found on the surface of the devices.

The caution from MHRA comes a day after Jeffrey Nugent, Sientra chairman and CEO, a US-based supplier of Silimed products, sent a letter to plastic surgeons informing them that an independent, third-party review of Sientra’s products concluded that they do not represent a risk to patients.

“We have been in continuous communication with the [US Food and Drug Administration] and based on the completion of this testing, we met our stated objective of submitting the data to the FDA prior to the end of 2015,” Nugent said.

Background

In September 2015, MHRA and EU member state regulators suspended all CE certificates for medical devices made by Silimed after a German notified body, known as TÜV SÜD, uncovered particles on the surfaces of some of the devices.

Silimed, which claims to be the largest manufacturer of silicone implants and the largest breast implant manufacturer in South America, manufactures a catalog 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.

Australia's Therapeutic Goods Administration (TGA), Singapore’s HSA and Swissmedic also recommended that surgeons not use the company’s implants.

FDA, meanwhile, told Focus in October that it concurred with Sientra’s recommendations to take a cautionary approach until more is known on the implants. Sientra temporarily halted all US sales of such devices when the international regulators expressed caution.

MHRA Update

On Friday, MHRA cautioned that although Silimed is saying the devices pose no risk to patients, the regulator’s investigation has yet to be completed.

“We are aware that Silimed have issued communications to suggest that there is no risk to patients however this is yet to be determined through our evaluation of testing,” MHRA said. “We will communicate the conclusions shortly. In the meantime our previous advice that devices should be quarantined continues to apply.”

That warning contrasts with Nugent’s letter from only a day earlier.

“Let me reiterate that all regulatory bodies that have been involved in the Silimed review, including the FDA, have consistently stated that there are no reports of adverse events in connection with this issue and no risks to patient health have been identified,” Nugent said. The company’s stock was up more than 10% on Friday.

MHRA Update

Sientra Letter


Categories: Regulatory News

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