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Silimed

Sientra soars after independent panel OKs breast implants

January 8, 2016 By Brad Perriello

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 […]

Filed Under: Cosmetic/Aesthetic, Regulatory/Compliance, Women's Health Tagged With: Sientra, Silimed

Sientra halts U.S. sales

October 12, 2015 By Brad Perriello

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 […]

Filed Under: Cosmetic/Aesthetic, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: Sientra, Silimed

Sientra hits 52-week low on Brazil’s Silimed implant ban

October 5, 2015 By Brad Perriello

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, […]

Filed Under: Cosmetic/Aesthetic, Regulatory/Compliance, Wall Street Beat Tagged With: Anvisa, Medicines & Healthcare products Regulatory Agency (MHRA), Sientra, Silimed

Sientra plummets on U.K. breast implant halt

September 25, 2015 By Brad Perriello

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 […]

Filed Under: Cosmetic/Aesthetic, Regulatory/Compliance, Wall Street Beat, Women's Health Tagged With: Medicines & Healthcare products Regulatory Agency (MHRA), Sientra, Silimed

U.K. halts use of Silimed breast implants amid contamination fears

September 24, 2015 By MassDevice

(Reuters) — Sales of silicone implants made by Brazil’s Silimed and used in thousands of patients in Britain have been suspended due to safety concerns, British medical regulators and suppliers said today. The Medicines & Healthcare Products Regulatory Agency (MHRA) said it and other European regulators are testing Silimed’s products – which include breast, penile and testicular implants […]

Filed Under: Cosmetic/Aesthetic, Regulatory/Compliance, Urology, Women's Health Tagged With: Medicines & Healthcare products Regulatory Agency (MHRA), Silimed

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