What are the rupture rates for MemoryGel™ Implants?
Mentor has very low rupture rates for our MemoryGel™ products. Our Core Study had 1007 patients, 420 of which participated in a MRI cohort to help study silent ruptures. At three years, our confirmed rupture rate (through explant) is 0.2% by patient and 0.3% by implant. Some patients in the study have had MRIs that appear to have ruptures. However, the patients have chosen not to have surgery to confirm the status of their implants– these are called suspected ruptures. The confirmed and suspected rupture rate is 1.1% by patient and 1.6% by implant. It is important to note that 3 suspected ruptures have undergone explant surgery and all implants were intact. The augmentation patient satisfaction rate was 98% for the respondents. What are the new conditions of approval? There are several conditions that the FDA has mandated with approval of silicone gel implants that are different from saline implants. • The augmentation patient must be at least 22 years of age. See Patient Labeling for
