In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
This is a new enrollment prospective (10-year) post-approval cohort study to collect additional post-approval clinical
data on the long-term clinical performance of MemoryShape and MemoryGel Breast Implants.
Study Population Description
Women who receive Mentor?s MemoryGel and MemoryShape breast implants for the purpose of primary or
revisional breast augmentation and primary or revisional breast construction. Additionally, women who undergo aesthetic surgery (for example liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty) will be enrolled as concurrent controls.
The study will enroll 2,518 women who receive Memory Gel and MemoryShape Breast Implants for
augmentation, reconstruction, augmentation revision or reconstruction revision.
The study will also enroll 300 women undergoing aesthetic surgery who will serve as concurrent controls.
Safety Endpoints to be evaluated are as follows: Local complications, connective tissue diseases, rheumatologic and
neurologic signs and symptoms, cancer, suicide, and lactation complications and magnetic resonance imaging (MRI) compliance and results.
Effectiveness will be assessed in a subset of breast implant patients by responses to questions addressing their perceived quality-of-life and satisfaction with their breast implants.
Followup Visits and Length of Followup
Patients will be followed for 10 years.
Frequency of Follow-up Assessments
MemoryGel and Memory Shape Breast Implant
patients will be evaluated by the investigator at baseline and years 1, 5, and 10 and will complete questionnaires at baseline and annually for 10 years. A concurrent control group of women undergoing other aesthetic surgery (these patients are referred to as Control participants) will complete questionnaires at baseline and annually for 10 years.
OSB Lead-MemoryGel and Shape Combined Cohort