Regulatory Medicines and Health Products UK (MHRA) on Agency, reiterated his call to quarantine implants manufactured by Silimed Brazil, saying it is still trying to determine if there are potential health risks associated with the particles on the surface devices.
The MHRA warning comes a day after Jeffrey Nugent, President and CEO Sientra, Silimed a supplier of products to the United States, sent a letter to the plastic surgeons advising them to an independent review, other products Sientra concluded that pose no risk for patients.
"We have been in constant communication with the [US Food and Drug Administration] and on the basis of the performance of this test, we have met our goal of presenting data to the FDA by the end of 2015," Nugent said.
The MHRA warning comes a day after Jeffrey Nugent, President and CEO Sientra, Silimed a supplier of products to the United States, sent a letter to the plastic surgeons advising them to an independent review, other products Sientra concluded that pose no risk for patients.
"We have been in constant communication with the [US Food and Drug Administration] and on the basis of the performance of this test, we have met our goal of presenting data to the FDA by the end of 2015," Nugent said.
Context
In September 2015, the regulators of the Member States and EU MHRA suspended the CE mark for medical devices manufactured by Silimed after a German notified body, known as TÜV SÜD, on the surfaces of the particles Some of the devices discovered.
Silimed, which claims to be the largest manufacturer of silicone implants and the largest manufacturer of breast implant in South America, produces a catalog of more than 5000 implants for plastic surgery, bariatric surgery (including strips and gastric balloons), urology , general surgery and other invasive silicone devices in more than 75 countries.
Therapeutic Goods Administration of Australia (TGA), HSA and Swissmedic Singapore also recommends that surgeons do not use implants society.
FDA, meanwhile, said in October that it agreed with the recommendations made by Sientra adopt a precautionary approach until more is known about implants. Sientra temporarily halted all US sales of these devices when international regulators have expressed reservations.
Silimed, which claims to be the largest manufacturer of silicone implants and the largest manufacturer of breast implant in South America, produces a catalog of more than 5000 implants for plastic surgery, bariatric surgery (including strips and gastric balloons), urology , general surgery and other invasive silicone devices in more than 75 countries.
Therapeutic Goods Administration of Australia (TGA), HSA and Swissmedic Singapore also recommends that surgeons do not use implants society.
FDA, meanwhile, said in October that it agreed with the recommendations made by Sientra adopt a precautionary approach until more is known about implants. Sientra temporarily halted all US sales of these devices when international regulators have expressed reservations.
MHRA Update
On Friday, the MHRA warned that although Silimed said the devices pose no risk to patients, research the regulator has not yet been completed.
"We are aware that Silimed have published papers suggesting that there is no risk to patients, but has yet to be determined through our assessment test" MHRA said. "We will communicate the conclusions shortly. Meanwhile our previous advice that the devices should be quarantined still applies."
This contrasts with the warning letter Nugent of only a few days before.
"Let me recall that all regulatory agencies that have participated in the Silimed review, including the FDA, has always said that there are no reports of adverse events related to this issue and none of the patients of health risks have been identified," said Nugent . Shares of the company rose more than 10% on Friday.
"We are aware that Silimed have published papers suggesting that there is no risk to patients, but has yet to be determined through our assessment test" MHRA said. "We will communicate the conclusions shortly. Meanwhile our previous advice that the devices should be quarantined still applies."
This contrasts with the warning letter Nugent of only a few days before.
"Let me recall that all regulatory agencies that have participated in the Silimed review, including the FDA, has always said that there are no reports of adverse events related to this issue and none of the patients of health risks have been identified," said Nugent . Shares of the company rose more than 10% on Friday.
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