Sientra Announces Services Agreement with Vesta

Sientra Inc., a medical aesthetics company, has entered into a services agreement with Vesta, a Lubrizol LifeSciences company and contract manufacturer of silicone products and other medical devices.
 
Under terms of the agreement, Vesta is establishing manufacturing capacity for Sientra and is working with the Santa Barbara, Calif.-based company to finalize a long-term supply arrangement for its PMA-approved breast implants. Sientra anticipates that all project milestones will be achieved for the company to submit a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) during the first quarter of 2017.
 
“Our relationship with Vesta is an important component of our comprehensive manufacturing plan. Vesta is an established manufacturer with proven capabilities in producing implantable silicone medical devices and components with a strong reputation for quality and safety,” said Jeffrey M. Nugent, chairman and CEO of Sientra. “We have already made significant progress with Vesta and we are confident that this ongoing relationship will enable us to uphold our promise to board-certified plastic surgeons to maintain an uninterrupted supply of our breast implant products. We believe our arrangement with Vesta will provide us a best-in-class supply chain that we can scale moving forward to support our long-term growth objectives. We are also looking forward to the prospects of working with Lubrizol LifeSciences and Vesta in the future on additional aesthetics technologies and innovations that can help meet unmet needs for our surgeons and their patients.”

Sientra last fall placed a temporary hold on sales of medical implants made by a Brazilian contract manufacturer, and recommended that plastic surgeons temporarily discontinue implanting all Sientra devices made by the Brazilian contractor, Silimed, until further notice. Executives said their decision followed discussions with the FDA regarding Brazilian regulatory inquiries into products manufactured by Silimed. Sientra also conducted its own review.

The Brazilian regulators in October also suspended the manufacturing of all medical devices made by Silimed. Sientra officials said Brazilian regulators have been reviewing technical compliance issues at Silimed’s manufacturing facility. However, Brazilian and other regulators never received any reports of adverse events or found any risks to patient health from the devices.
 
“Lubrizol LifeSciences/Vesta is excited about furthering its commitment to deliver the highest quality medical components and products with an innovative strategic partner like Sientra,” said Deb Langer, vice president and general manager of Lubrizol LifeSciences. “Our experience in the implantable cosmetic market and our know-how of silicone component manufacturing positions us well to best support Sientra’s continued success.”
 
Sientra is a medical aesthetics company committed to making a difference in patients’ lives by enhancing their body image, growing their self-esteem and restoring their confidence. The company was founded to provide greater choice to board-certified plastic surgeons and patients in need of medical aesthetics products. The company has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The company offers a range of aesthetic and specialty products including bioCorneum, for scar management.
 
Headquartered in Franklin, Wis., Vesta Intermediate Funding Inc. is a Lubrizol LifeSciences company. Vesta has more than 40 years of experience serving the medical device industry, exclusively specializing in precision thermoplastic extrusion and comprehensive silicone fabrication.