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 MemoryShape PAS is a new enrollment prospective (10-year) post-approval cohort study to evaluate the
long-term clinical performance of MemoryShape Breast Implants. The study will enroll 2,518 women receiving MemoryShape Breast Implants. Four cohorts will be included: primary augmentation, revision-augmentation, primary reconstruction, and revision- reconstruction. For the purpose of assessing rheumatological and neurological signs and symptoms, there will be a control group of 300 women selected from the participating investigators¿ practices, undergoing an aesthetic surgery other than breast implant surgery. Breast implant patients and the concurrent control group patients will all be followed for 10 years.
Study Population Description
Women who receive Mentor¿s 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.
Eligibility of Memory Shape Breast Implant Patients Inclusion criteria
1. Is a candidate for breast augmentation with MemoryShape¿ Breast Implants and is at least 22 years old (primary or revision)1 OR is a candidate for breast reconstruction (primary or revision)2 with MemoryShape¿ Breast Implants 2. Signs an Acknowledgement of Informed Decision from the patient brochure 3. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records 4. Agrees to answer baseline questions 5. Agrees to authorize return of the device(s) to Mentor if the device is explanted 6. Agrees via Informed Consent to comply with study follow-up, including attending office visits and responding to questionnaires in their entirety
1. Has active infection anywhere in her body 2. For augmentation subjects, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction subjects, has a history of cancer of any kind, except non- melanoma skin cancer or adequately treated breast cancer 3. Has a confirmed diagnosis of connective tissue disease or neurological disease 4. Is currently pregnant or nursing 5. Is planning on undergoing or has undergone bariatric surgery 6. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study
Eligibility of Other Aesthetic Surgery Patients
Inclusion criteria 1. Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty) and is at least 22 years old 2. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records 3. Agrees to answer baseline questions 4. Agrees via Informed Consent to comply with study follow-up, including responding to questionnaires in their entirety
1. Has ever had, unilateral or bilateral, breast implants (including breast tissue expanders) 2. Expects to undergo breast implant surgery during the study period 3. Has ever had silicone implants anywhere in her body 4. Has active infection anywhere in her body 5. Has a history of cancer of any kind, except non-melanoma skin cancer 6. Has a confirmed diagnosis of connective tissue disease or neurological disease
7. Is currently pregnant or nursing 8. Is planning on undergoing or has undergone bariatric surgery 9. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study
Mentor will enroll 2,518 women who receive 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
Both MemoryShape Breast Implant patients and control group patients will complete an informed consent form,
baseline questionnaire to be enrolled in the study.
For breast implant patients, the investigator will report the date of surgery and, for each implant, implant serial number, implant type and size, surgery type, incision location and size, and implant placement. Follow-up questionnaires will be completed annually by breast implant patients. At Year 1, Year 5, and Year 10, the questionnaires will be filled out at the office during the investigator visit. In addition, the investigator will complete the Investigator Local Complications and Secondary Procedure Form. At Years 2-4 and Years 6-9, questionnaires, provided by Mentor or appropriate designee, are to be completed off-site by the patient.
For concurrent control group patients, the investigator will record the date of surgery and the type of other aesthetic surgery. Annual follow-up questionnaires, provided by Mentor or appropriate designee, are to be completed off-site by the concurrent control group patients.
Clinical performance and safety will be examined based on the following outcomes in women receiving MemoryShape Breast Implants: ¿Local complications ¿CTDs ¿Rheumatological signs and symptoms ¿Neurological Diseases ¿Neurological signs and symptoms ¿Offspring complications ¿Reproductive complications ¿Lactation complications ¿Cancer ¿Suicide ¿Mammography ¿MRI compliance and results ¿Quality of life and satisfaction
Followup Visits and Length of Followup
MemoryShape 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 also be enrolled and will complete questionnaires at baseline and annually for 10 years.
OSB Lead-MemoryShape PAS (MemoryShape PAS)