Stop implanting breast implants made by contract manufacturer Silimed. Santa Barbara-based Sientra has told US surgeons to stop implanting breast implants made by contract manufacturer Silimed. Qmed reports that the company has stopped selling the devices in the US after regulators in other countries, including Brazil and the UK, suspended the implants. Silimed’s Brazilian factory was found to have unidentified particles on some manufacturing surfaces during a German audit.
Temporarily discontinue implanting all Sientra devices
In a letter to surgeons, Sientra CEO Hani Zeini wrote “We have been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding this matter and out of an abundance of caution, we are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed,” according to Qmed.
“We are also voluntarily placing on temporary hold, the sale in the United States of all Sientra devices manufactured by Silimed, and we ask that you set aside all such devices in a secure location and not use them until further notice.”
Sientra did not advise surgeons to remove the implants and no injuries have been reported so far. The company is conducting an internal review of the issue.