The U.S. Securities & Exchange Commission today accused former Sientra (NSDQ:SIEN) CEO Hani Zeini of hiding a problem at the company to close a $61 million follow-on offering that led to the company losing more than half of its value. The breast implant maker relied on a single supplier for its silicone implants. But regulators in […]
FDA OKs Opus breast implant line from Sientra
The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]
Sientra inks contract manufacturing deal with Lubrizol’s Vesta
Sientra (NSDQ:SIEN) said today that it inked a contract manufacturing deal for its breast implants with Lubrizol LifeSciences subsidiary Vesta. Santa Barbara, Calif.-based Sientra was off the market for 4 months after Brazilian regulators shut down production last year at its sole supplier. The company, which was back on the market March 1, was stymied […]
Sientra jumps on return to U.S. market
Sientra (NSDQ:SIEN) shares jumped today after the breast implant maker said all of its products are slated to go back on the U.S. market March 1, 4 months after Brazilian regulators shut down production at its sole supplier. Santa Barbara, Calif.-based Sientra tapped new CEO Jeffrey Nugent shortly after Brazilian regulator Anvisa last October suspended production at Silimed, Sientra’s […]
Sientra soars after independent panel OKs breast implants
Shares of Sientra (NSDQ:SIEN), which hit a 52-week low last year after regulators shut down production at its sole supplier, soared today after new CEO Jeffrey Nugent said independent testing found its breast implants safe for implantation. Santa Barbara, Calif.-based Sientra tapped Nugent shortly after Brazilian regulator Anvisa suspended production at Silimed, Sientra’s supplier, and the U.K.’s Medicines & Healthcare Products Regulatory […]
Sientra taps medtech vet Nugent for CEO
Embattled breast implant maker Sientra (NSDQ:SIEN) said yesterday that it tapped medical device and pharmaceutical industry veteran Jeffrey Nugent to be its chairman & CEO, effective immediately. Nugent, older brother to musician and gun-rights activist Ted Nugent, replaces CEO Hani Zeini and chairman Nicholas Simon, both of whom are slated to retain their seats on the board. Nugent was the […]
No timeline on Sientra’s return to breast implant market
There’s no timeline yet for a return to the U.S. market with its breast implants, Sientra (NSDQ:SIEN) CEO Hani Zeini told analysts this week. Earlier this month Sientra put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, after Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales after contamination was detected […]
Sientra halts U.S. sales
Breast implant maker Sientra (NSDQ:SIEN) last week put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, sending its shares down 11% in after-hours trading. Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales of implants made by Silimed, which is Sientra’s sole supplier, after contamination was detected during an audit of […]
Sientra hits 52-week low on Brazil’s Silimed implant ban
Shares of Sientra (NSDQ:SIEN) plunged a further 20% today to a 52-week low after Brazilian regulator Anvisa last week suspended the production, sale and use of products made by Brazil’s Silimed, Sientra’s sole supplier of breast implants. The news follows a decision last month by the U.K.’s Medicines & Healthcare Products Regulatory Agency to suspend sales of Silimed implants, including breast, […]
Sientra plummets on U.K. breast implant halt
Shares of breast implant maker Sientra (NSDQ:SIEN) plummeted some 53% yesterday after British medical regulators suspended sales of implants made by Sientra’s Brazilian supplier Silimed. The U.K.’s Medicines & Healthcare Products Regulatory Agency yesterday said it and other European regulators are testing Silimed’s products – which include breast, penile and testicular implants – after contamination was detected during an audit of […]
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