FDA approves J&J’s Mentor MemoryGel Xtra silicone breast implants

Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it won FDA approval for its MemoryGel Xtra silicone gel-filled breast implants.

With the approval, Mentor said it also launched an Artoura breast tissue expander designed to work with the newly cleared MemoryGel Xtra implants. The Artoura breast tissue expander features a smooth shell to provide controlled expansion for reconstructive surgeries.

“Since its launch in 2015, the Mentor Artoura expander platform has proven to be a welcome innovation in breast tissue expander technology. Having a new smooth shell configuration, in addition to the existing Siltex textured shell, gives me the ability to select an appropriately surfaced expander for my patients, which has previously not been available.  I’ve continued to add the smooth-shelled Artoura Expander into my practice and have been very pleased with the performance of the device, particularly with the final aesthetic result after expander-to-implant exchange,” Dr. Salvatore Pacella of La Jolla, Calif.’s Scripps Clinic and Green Hospital said in a prepared statement.

“I look forward to being able to provide women with this new style of implant to consider, as they evaluate the options associated with breast implant surgery. Mentor MemoryGel implants, with their soft, natural feel, have been a great fit for many of my patients throughout the years. Each enhancement to the MemoryGel product line has been thoughtfully designed with patients in mind,” Dr. Louis Strock of the American Board of Plastic Surgery said in a press release.

In February, Mentor was hit with a product liability lawsuit in California state court which claimed that its silicone breast implants cause muscle pain, nausea and other symptoms.

Mentor allegedly failed to run adequate clinical studies establishing the implants’ safety, plaintiff Rexine Mize claimed in the lawsuit, according to Bloomberg. The implants leak silicone, leading to a variety of ailments, according to the suit.

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