Weeks after it put a temporary hold on all U.S. sales of devices made by a Brazilian contract manufacturer, Santa Barbara, Calif.-based Sientra has announced that founder and CEO Hani Zeini is stepping down.
Zeini will be replaced by board member Jeffrey Nugent, former head of Biolase. Zeini will continue to serve on the company’s board and in a consulting capacity.
Zeini isn’t the only Sientra executive making a change. Nicholas Simon is stepping down from his role as chairman, but will remain on the company’s board. Meanwhile, the company says Joel Smith is resigning as general counsel, chief compliance officer and corporate secretary, effective immediately.
The company is scheduled to provide its third quarter results today.
Margaret Kaczor and Scott Schaper of William Blair say the announcement comes “somewhat of a surprise,” adding that they view the underlying assets of Sientra as “valuable.”
In late September, the UK’s Medicines and Healthcare products Regulatory Agency, along with other European health regulators, suspended CE certification for all products made by Brazilian contract manufacturer Silimed after particle contamination was discovered during a facility inspection (). Sientra, which uses Silimed, subsequently put a hold on sales of products manufactured by the Brazilian company.
The plot thickened last month, after a fire broke out at a Silimed facility that manufactures Sientra’s breast implants. During a call, Zeini said the circumstances surrounding the Oct. 22 fire “remain under review,” and Brazilian authorities are investigating. At the time of the call, the extent of the damage was unknown.
Silimed had informed Sientra that another smaller building could be modified to manufacture the implants. Doing so would require the reconfiguration of certain areas in the facility, as well as certification and approval by appropriate regulatory authorities.
Zeini added that Sientra would examine all of its options, including alternative manufacturing arrangements. — Elizabeth Hollis