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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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MemoryGel and Shape Glow Study


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General
Study Status Progress Inadequate
Application Number P060028 / PAS003
Date Current Protocol Accepted 07/01/2020
Study Name MemoryGel and Shape Glow Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description On August 30th -31st, 2011, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (link) met to discuss updates on the postmarket experience of silicone gel-filled breast implants and to make recommendations on issues related to the monitoring of silicone gel-filled breast implants. The Advisory Panel recommended more efficient approaches to assessing the performance of silicone gel-filled breast implants than continuing new enrollment in the large prospective studies. Their recommendations included conducting a systematic literature review and re-designing the Large Post-Approval Studies (PAS) to have more efficient methodologies to assess rare outcomes. In response, FDA entered a collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant anaplastic large cell lymphoma (BI-ALCL)). Tufts University was tasked with conducting a systematic literature review to look at rare endpoints and silicone gel-filled breast implants. Details on the literature review methodology and findings can be found here (Balk EM, et al., Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016. 2;164(3):164-75).

The MemoryGel and Shape Glow Study was designed as part of the re-design of the Large PAS. This is a smaller cohort study (10 years follow-up) designed to address safety outcomes (i.e., including local complications, less rare connective tissue diseases, rheumatologic and neurologic signs and symptoms, breast cancer, lung cancer and suicide), reproduction and pregnancy outcomes, lactation problems, effects on mammography, effects on patient satisfaction with breasts and psychosocial wellbeing, and silicone subject compliance with magnetic resonance imaging (MRI) recommendations.

This restructured PAS, once completed as designed, would satisfy the post-approval requirements for both the MemoryGel® (P030053) and Memory Shape (P060028) silicone breast implants. In addition, information gained from the NBIR will help strengthen the general understanding of implantation rates and certain risks associated with 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.

Sample Size The study will enroll 3,500 women who received MemoryGel or MemoryShape Breast Implants, with a minimum of 750 subjects enrolled in each device family, and a concurrent control group of 300 women undergoing an aesthetic surgery other than breast implant surgery.



The study was designed to have 80% power to be able to detect as statistically significant a relative risk of 2.0 for adverse events that occur, without implants, with a frequency of 5.0 per 10,000 person-years, based on a one-sided test conducted at level of significance of 0.05. Based on these specifications, it was determined that approximately 20,328 person-years would be required.



Patients are to be followed for 10 years. For purposes of sample size calculation, assuming a follow-up rate of 65% at 10 years and a linear loss to follow-up, there would be an average of 8.075 person-years per patient. Thus, in order to obtain the 20,328 person-years, a total of at least 2,518 breast implant patients would be required.





Data Collection Data on all study patients will be collected on the following safety endpoints: local complications, connective tissue disease (CTD), rheumatologic and neurologic signs and symptoms, cancer, suicide, and lactation complications. Magnetic resonance imaging (MRI) compliance and results will also be evaluated. 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. Data for the concurrent control group patients will be collected for rheumatological and neurological signs and symptoms.
Follow-up Visits and Length of Follow-up Prospective patients are considered enrolled in the study after completing the Informed Consent Form, baseline questionnaire, and surgery.



Enrollment in the MemoryShape group will include women who enroll prospectively, before undergoing their implant surgery, and women who enroll retrospectively, after having undergone their implant surgery.



At Years 1 to 10, online questionnaires are to be completed off-site by the breast implant patients. At Years 1, 5, and 10, the online BREAST-Q will be completed off-site by a subset of patients. Retrospectively enrolled patients will be required to complete follow-up questionnaires annually through the 10-year anniversary of the index surgery. All study patients will be seen by the investigator at any standard-of-care office visits and relevant adverse events will be captured in the study database.



At Years 1 to 10, online questionnaires are to be completed off-site by the concurrent control group patients.





Patients will be followed for 10 years.



MemoryGel and Shape Glow Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/13/2013 12/09/2013 On Time
one year report 06/14/2014 06/10/2014 On Time
18 month report 12/13/2014 12/08/2014 On Time
two year report 06/14/2015 06/03/2015 On Time
3 year report 08/12/2016 08/10/2016 On Time
42 month report 02/12/2017 02/03/2017 On Time
4 year report 08/13/2017 08/10/2017 On Time
54 month report 02/12/2018 02/12/2018 On Time
yearly report 02/12/2019 02/12/2019 On Time
yearly report 02/12/2020 02/12/2020 On Time
yearly report 02/12/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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