Sientra breast implants are back in the United States. This fall when Silimed had their CE mark temporarily suspended by the main European device regulator, Sientra, who shared a manufacturing facility with Silimed, voluntarily withdrew their products from the U.S. market to allow an investigation of Silimed’s manufacturing facility to take place.
By John Hammarley
The Plastic Surgery Channel
After a period of months where implants were off limits to surgeons – and Sientra’s stock and future confidences took a tremendous tumble – the company has given the green light to U.S. surgeons to use the implants.
CEO, Jeffrey Nugent in a letter noted, “We have completed extensive independent studies… and the overwhelming conclusion is that we are more confident that all Sientra products meet the standards of quality and safety.” He elaborates further that their controlled reentry into the U.S. will allow surgeon customers to readily access Sientra’s “significant inventory” of approved implants.
What this hiccup means for the company, only time will tell. The FDA has to date voiced no concerns over Sientra devices, and for now, U.S. surgeons and patients have more breast implant options and choices!