Medical aesthetics firm Sientra Inc. announced that it is temporarily halting the sale of products manufactured by a contractor in Brazil, causing company shares to drop by as much as 11 percent in extended trading.
Sientra's sale suspension comes after health regulators in the South American country launched a review of manufacturing practices employed by breast implant maker Silimed.
Sientra said that after consulting with the U.S. Food and Drug Administration (FDA), the company has decided to discontinue offering Silimed-made devices to clients and advise plastic surgeons not to use products from the Brazilian contractor in their implants until further notice.
Hani Zeini, founder and CEO of Sientra, wrote in a letter to plastic surgeons that the suspension is part of the company's precautionary measures.
He pointed out that there have been no reports of any adverse effects or potential risks to patients identified in relation to the implanting of Silimed-made products.
Zeini added that regulatory authorities, including Brazilian agencies, have found no immediate need to explant these products or adopt specific actions or procedures for individuals who have received them. He said that foreign regulators involved in the review have reiterated this finding in their public statements.
Zeini advised plastic surgeons that while the review is still ongoing, they can reassure their patients by informing them that there is no indication that the product issues would pose risks to their safety.
He added that if their patients encounter any complications with their Sientra implants, they should contact the surgeons immediately as part of the standard follow up on patients.
Sientra said that it will also launch its own review regarding products manufactured by Silimed.
Based in Santa Barbara, California, Sientra's goal is to provide patients with the means to improve their lives by helping them enhance their body image, restore their confidence and grow their self-esteem.
The medical aesthetics firm has developed a broad portfolio of devices and specialty products, including breast implants and breast tissue expanders, which it offers exclusively to board-admissible and board-certified surgeons.
Following Sientra's suspension of Silimed products, the company's shares have plummeted to around 32 percent since Monday, Oct. 5.
Photo: Rachel Ramos | Flickr
