This case is still ongoing as of November 2019. Sientra makes Opus silicone breast implants. The two companies are Mentor Worldwide LLC, of Irvine, Calif., which is owned by Johnson & Johnson, and Sientra, Inc., of Santa Barbara, Calif. Mentor makes MemoryShape, MemoryGel, and Spectrum silicone breast implants, as well as saline implants. † In the event of a confirmed rupture or deflation (leaking) of any MENTOR® Breast Implant due to wear or delamination requiring surgical intervention, regardless of the age of the implant, Mentor will provide a free replacement of a MENTOR® Breast Implant of any size in the same or similar style as the originally implanted product. My implants were put in in 2008 and were Mentor Saline Implants. In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Ever since the Food and Drug Administration recalled textured breast implants in late July, the phone has not stopped ringing at the office of … **As compared to saline-filled breast implants. Textured implants made by Allergan, a major U.S. manufacturer, were taken off the market in Europe last December. After its implants were first approved by the FDA, Allergan was required to conduct a large, 10-year study of nearly 60,000 participants with gel- and saline-filled implants. Inamed (now Allergan) Saline Breast Implants (P020056) In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. linda August 30, 2017 at 7:48 pm Reply I have a Mentor Saline implant and have been having pain and numbness in … The Future of Mentor Breast Implant Lawsuits Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. Mentor is committed to product safety. Mentor conducted a 5-year study on reconstruction patients. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report . *As compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression 1. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. Read the FDA announcement. MENTOR ® MemoryGel ® Breast Implants, MENTOR ® MemoryShape ® Breast Implants, and MENTOR ® Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel ® Implants and MemoryShape ® Implants, and 18 years old for Saline Implants) or for breast reconstruction. Allergan voluntarily recalled its Biocell textured breast implants last week after the Food and Drug Administration (FDA) pushed for the company to take them off the market. Actions Requested If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action. Learn how. The safety and clinical performance of MENTOR® Breast Implants is … Breast implant surgery should not be performed … Mentor Saline Implants.