3 Clinical Trials for Various Conditions
The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.
While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device. Up to 12 patients per month at sites across the United States will be enrolled in this research study. These patients will be implanted with the Becker 25 or Becker 50 Expander/Breast implant and monitored for 10 years for safety.