• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

OSB Lead-Core


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P020056 / PAS002
Current Plan Approved 11/17/2006
Study Name OSB Lead-Core
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a 10-year followup of the Core Clinical Study with the objecitve to document the safety and effectiveness of Allergans (formerly Inamed) Silicone-Filled Breast Implants as indicated for breast augmentation, breast reconstruction, or breast implant revision in existing Core IDE Study patients.
Study Population Description The study population is as per device indication. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast Augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the results of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
Sample Size 940 participants, 46 sites.
Data Collection Effectiveness endpoints are circumferential chest size change, bra cup size change (augmentation patients only), patient satisfaction, quality of life ( measures of self-esteem, body image, and general health outcome). Safety endpoints are complication rates, reasons for re-operation and reasons for implant removal.
Follow-up Visits and Length of Follow-up Patients were to be followed for 10 years. Patient follow-up is at 6 months, 1 year, 2 years, and annually through 10 years post-implant. Rupture is assessed for patients who have scheduled MRIs at years 1, 3, 5, 7, and 9 years to screen for silent rupture (i.e., MRI cohort) and those who are not assessed for rupture by scheduled MRIs (i.e., non-MRI cohort). All patients in the post-approval study will undergo MRI at 7 and 9 years post-implantation
Final Study Results
Interim Safety Information The overall follow-up rate was 73.2% (range: 67.8%-81.0%) at 9 years. There were no significant increases the complication rates between year 8 and year 9.The most commonly reported complications reported by augmentation, revision-augmentation, and reconstruction patients were capsular contracture and breast pain. The rates of capsular contracture and breast pain are similar or below previous reported rates per IOM report and prospective studies of saline-filled breast implants approved by FDA in May 2000. Specifically, the 9-year risk rate by patient with a frequency of more than 10% were capsular contracture (17.6%), breast pain (10.9%), and swelling (8.9%) for augmentation patients; capsular contracture (25.5%), breast pain (11.7%), and swelling (8.3%) for revision-augmentation, capsular contracture (24.9%), asymmetry (23.2%), and wrinkling/rippling (10.2%) for reconstruction and, implant malposition (13.3%) for revision-reconstruction.
Number of Patients 715 patients including 455 primary augmentation, 147 revision-augmentation, 98 primary-reconstruction and 15 revision-reconstruction patients.
Number of Sites 23
Follow-up Rate The follow-up rates for each cohort varied, but the overall rate was above 65% at Year 10. The follow-up rate was highest in the revision-reconstruction group and lowest in the revision-augmentation group. Specifically, the follow-up rate at Year 10 by cohorts were as follows; 66.8% in the augmentation cohort 63.8% in the revision-augmentation, 75.4% in the reconstruction and 80.0% in the revision-reconstruction cohort.
Safety Findings The most commonly reported complications for all cohorts include capsular contracture, breast pain, swelling, symmetry, wrinkling and implant malposition. The overall implant rupture rates by patient were 9.5% in the augmentation, 6.3% revision-augmentation, 27.2% in the reconstruction, and 6.7% in the revision-reconstruction cohort. The rate of any reoperation by 10 years post-implant was highest in the reconstruction cohort (71.5%), followed by revision cohorts (46.7% in the revision-reconstruction and 46.0% in the revision-augmentation cohorts), and lowest in the augmentation cohort (36.1%). The most frequently reported reason for reoperation varied with the indication. The most common primary reasons for reoperation were asymmetry, capsular contracture, device rupture, implant malposition, need for biopsy, patient request for style/size change and ptosis. Specifically for the revision-reconstruction patients, nipple complications were reported as the most common reason for reoperation. The incidence of breast implant removal by 10 years post-implant was highest in the reconstruction cohort (53.8%), followed by in the revision-augmentation cohort (32.4%), in the augmentation cohort (18.6%) and in the revision-reconstruction cohort (13.3%). The most common reasons for replacement/removal vary depending on the indication group. The most common reasons for implant replacement and removals are as follow: Asymmetry, capsular contracture, device rupture, implant malposition and patient request for style/size change.
Effect Findings Majority of the patients and physicians were satisfied with the surgical outcome. In the augmentation cohort, the patient and physician satisfaction was 93% and 94%, respectively, 84% and 83% in the augmentation revision cohort, 84% and 86% in the reconstruction cohort, 72% and 80% in the revision-reconstruction cohort
Strengths & Weaknesses One of the study strength is that the study is a prospective, multicenter study that provides long term data up to 10 years on the safety and effectiveness of the device. The weaknesses of the study were the lack of a comparison group and lack of statistical power to detect rare events due to the small sample size
Label Changes The labeling will be updated based on the safety and effectiveness results reported in the final PAS report.


OSB Lead-Core Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
CORE 1 year Study Report 11/17/2007 11/16/2007 On Time
CORE 2 year Report 11/16/2008 11/14/2008 On Time
CORE 3 year Report 11/16/2009 11/16/2009 On Time
CORE 4 year Report 11/16/2010 11/12/2010 On Time
CORE 5 year Report & Final Report 11/16/2011 08/26/2011 On Time
response to R43 RDEF & Final Report 03/17/2012 03/15/2012 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-