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.
The Continued Access Study (CAS) was initiated to allow for continued physician experience with the
device and to collect additional safety data. The PACAS is a post-approval continued access study designed to evaluate the safety of Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants in subjects previously enrolled in Mentor¿s CAS. Upon device approval, CPG CA study subject enrollment will be closed and the study will be converted to a post approval study for this style, i.e., CPG Style 321. The PACAS is to continue clinical follow-up of these patients with CPG Style 321 until each patient reaches her 5th year post-implantation. Subjects enrolled in the CA study with other CPG style breast implants will be followed under a new IDE protocol and study.
Study Population Description
Women with Mentor¿s MemoryShape Medium Height, Moderate Profile (CPG Style 321) Breast Implants as indicated
for primary augmentation and revision augmentation of the female breast who were enrolled in the CAS but have not yet completed their 5-year follow-up.
A total of approximately 350 subjects who were enrolled in Mentor¿s Continued Access Study and
implanted with MemoryShape Medium Height, Moderate Profile (CPG Style 321) for augmentation and reconstruction of the female breast and have not yet completed the 5-year study visit
During the 5-year follow-up period, safety of the implants will continue to be measured by
collecting the incidence, severity, method of resolution and duration for all complications (including device failures and adverse device effects) on a per-implant and per-patient basis. Rheumatic Disease questionnaire will be employed at years 1, 2, 4 and 5. All PACAS subjects will be advised to see their surgeon if they believe they have a ruptured implant, and these subjects will undergo a Magnetic Resonance Imaging (MRI) scan.
Followup Visits and Length of Followup
Subjects will be seen by the investigator in the investigator's office once a year until
all subjects have reached 5-years post-implantation. Follow-up study visits will take place at 10 weeks and then annually through 5 years after surgery.
Post-approval Continued Access Study (PACAS)