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

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OSB Lead-Breast Implant Case-Control Studies


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General
Application Number P060028 / PAS004
Current Plan Approved 06/14/2013
Study Name OSB Lead-Breast Implant Case-Control Studies
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent & Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Five case-control studies will be conducted in Denmark, Germany, and the United Kingdom for

5 rare disease outcomes: rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. The round gel implants were introduced in Europe in 1985-1986, while the shaped gel implants have been in use in Europe since 2001, both for breast reconstruction and augmentation.



The studied diseases will be identified from a wide network of specialized medical centers, specialized institutions in major hospitals and health care centers in case of rare CTDs and rare neurological diseases as well as cancer registries or their associated tumor centers in case of brain, cervical/vulvar cancer and lymphoma. Controls will be obtained from randomly selected households. Overall, 1,150 cases (350-400 per country) and 5,000 controls (1,600-1,700 per country) will be enrolled into the study.



One large control group from the same neighborhood as cases will be used as a comparator for the studies.



These five case-control studies will investigate the risk of studied diseases in women with

Mentor shaped and round silicone gel-filled breast implants compared to the risk of women who never had breast implants. Furthermore, the effect of any type of breast implant on the five studied diseases will be investigated.



The case-control studies will test the null hypothesis that women in Denmark, Germany and the United Kingdom with rare diseases studied are not more likely to have had exposure to Mentor¿s MemoryShape breast implants compared to women who do not have the rare diseases studied. The alternative hypothesis is that diseased women are more likely to have had exposure.

Study Population Description Women in Denmark, Germany, and the United Kingdom with the studied rare diseases (i.e., rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women without any of the 5 studied rare diseases from the same countries as cases.



Inclusion criteria for cases:



¿Alive at the time of enrollment

¿Between 22 and 60 years of age at the time of enrollment

¿Identified with one of the ICD10 codes included in the protocol for the 5 studied diseases

¿Valid histological or staging information (for cases with brain cancer, cervical/vulvar cancer and lymphoma



Exclusion criteria for cases:



¿Women with a history of malignancy, connective tissue disease or neurological disease at the time of diagnosis

Women who either refuse to give permission to use their registry information, or do not live in the respective country or do not speak English, Danish or German, respectively



Inclusion criteria for the controls:



¿Between 22 and 60 years of age at the time of enrollment

¿Willing to provide the necessary information on their medical history (including the exposure to breast implants) and potential confounders



Exclusion criteria for cases:

¿Women who either refuse to give permission to use their registry information, or do not live in the respective country or do not speak English, Danish or German, respectively

¿Women with a history of any condition studied in the array of five case-control studies.

¿Women who provide unclear information that cannot be clarified by the interviewers

Sample Size For each of the 5 case-control studies, 1,150 cases of women diagnosed with studied rare disease identified from the specialized medical centers and cancer registries in Denmark, Germany and the UK will be enrolled. A total of 5,000 females identified from the same neighborhood as cases without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
Data Collection Data will be collected by using questionnaires as well as electronic information provided by the cancer registries/tumor centers. The same questionnaires will be used for cases and controls. The participating women will fill in the questionnaires on potential confounders (e.g., life-style related covariates) and exposure to breast implants. Similar questionnaires have been

successfully used in previous case-control studies with self-administered questionnaires.



The documented information will include:



-Country code

-Study site number

-Case/control ID number

-Date of birth

-Age at menarche

-History of pregnancies

-Regular menstrual bleeding

-Start of menopause

-History of breast implant

-Reason for breast implant (cosmetic, reconstruction, other)

-Names, types, and dates for breast implants

-Reasons for switch or stop of breast implant

-History of hormonal contraception

-History of hormone replacement therapy

-History of infection with HIV, Helicobacter pylori, or EBV

-Frequency of routine medical check-up in the decade before diagnosis of rare disease studied

-Number of lifetime x-rays, including computerized tomography

-Staging and histological information on lymphoma

-Date of lymphoma diagnosis

-History of other cancer

-History of other severe diseases

-History of treatment with immunosuppressive drugs

-Family history lymphoma

-Marital status

-Educational level achieved

-Professional exposure to radiation

-Postal code as proxy for size of town or city

-Body height

-Body weight

-Smoking status

-Alcohol consumption

-Level of physical exercise

-Date of completion of questionnaire

Follow-up Visits and Length of Follow-up There is no follow-up for case-control studies.


OSB Lead-Breast Implant Case-Control Studies Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 09/13/2013 09/12/2013 On Time
9 month report 03/14/2014 03/11/2014 On Time
one year report 09/14/2014 09/08/2014 On Time
18 month report 03/13/2015 03/06/2015 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

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