The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct […]
Mentor launches breast implant warranty program
Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it launched the MentorPromise Protection Plan, a new comprehensive warranty program for all Mentor breast implants sold in the US. The San Diego, Calif.-based company said that all Mentor breast implant recipients will be automatically enrolled in the plan, with an enhanced version of the plan available for […]
Johnson & Johnson’s Mentor sued over silicone breast implants
Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide’s silicone breast implants are accused of causing muscle pain, nausea and other symptoms in a product liability lawsuit reportedly filed in California state court last week. Mentor allegedly failed to run adequate clinical studies establishing the implants’ safety, plaintiff Rexine Mize claimed in the lawsuit, according to Bloomberg. […]
FDA approves trial for J&J’s Mentor MemoryGel breast implant
Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it won FDA investigational device exemption approval for its Athena clinical trial testing its Mentor MemoryGel breast implants. The Mentor MemoryGel beast implants are designed for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed mastectomy tissue, the company […]
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