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, penile and testicular implants, after contamination was detected during an audit of the company’s manufacturing practices. SIEN shares plummeted some -53% Sept. 24 in reaction to the British regulator’s move. In Brazil, Anvisa described the ban as “a precautionary measure” after a recent inspection confirmed the German authority’s findings. The regulator said it was carrying out tests on these products to assess any risks. That pushed SIEN shares down another -20.1% today to $8.29 per share in mid-afternoon trading, after they logged a 52-week low of $8.01. In a statement Silimed said that it has always maintained the highest quality standards and that the existence of sterile particles do not represent a health risk. It is working with European and Brazilian regulators to reverse the decision, it said. Silimed claims to be the largest manufacturer of silicone implants in South America. It is 1st in sales in Brazil, 3rd in the world and exports devices to more than 75 countries worldwide. Leerink Partners analyst Richard Newi...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cosmetic/Aesthetic Regulatory/Compliance Wall Street Beat Anvisa Medicines & Healthcare products Regulatory Agency (MHRA) Sientra Silimed Source Type: news