Status:
COMPLETED
Study of Health Effects of Cosmetic Breast Augmentation
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain Cancer
Breast Cancer
Eligibility:
FEMALE
21-69 years
Brief Summary
This study will examine long-term health effects of cosmetic breast augmentation (enlargement) with silicone gel breast implants. There has been concern for some time about the possible effects of bre...
Detailed Description
Although approximately 2 million women in this country have undergone augmentation mammoplasty, little is known about long-term effects. There has been concern for some time regarding possible effects...
Eligibility Criteria
Inclusion
- INCLUSION AND EXCLUSION CRITERIA:
- The following criteria for inclusion in the study cohort will apply:
- Age. No age restrictions apply; patients receiving cosmetic implants at any age will be eligible for study.
- Cosmetic augmentation only. Patients with breast reduction surgery or reconstructive surgery following breast cancer will not be included.
- Females only. Implants in conjunction with sex change surgery will not be included.
- Bilateral implants only. Patients with unilateral implants will not be included.
- First occurrence of a breast implant. Patients with a previous breast implant will not be included.
- Patients with a history of plastic surgery involving silicone exposure will not be included.
- Patients with a history of breast cancer at or before the time of implant will not be included.
- Patients residing in defined geographic areas at the time that their plastic surgery was sought (these areas will need to be individually defined for each study site).
- Patients with a history of breast surgery for non-cancerous events, those with a history of cancer of sites other than the breast, and those with documented histories of connective tissue disorders will continue to be eligible for cohort inclusion, although information on these conditions will be abstracted so that separate analyses can be pursued.
- For the comparison cohort, items a, c, f, g, h and i will apply. Patients currently receiving an operation involving implantation of silicon will not be included in the comparison cohort.
Exclusion
Key Trial Info
Start Date :
January 10 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 10 2020
Estimated Enrollment :
17424 Patients enrolled
Trial Details
Trial ID
NCT00342953
Start Date
January 10 2003
End Date
July 10 2020
Last Update
July 14 2020
Active Locations (1)
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1
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892