Study of Health Effects of Cosmetic Breast Augmentation
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|ClinicalTrials.gov Identifier: NCT00342953|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 14, 2020
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 breast implants on the immune system particularly regarding the development of certain connective tissue disorders and on the possibility that implants may interfere with the ability to detect breast cancers. More recently, concerns have been raised regarding the possible cancer-causing effect of the implants themselves. These concerns were heightened by reports that the polyurethane foam coating that envelops the silicone gel in some implants may dissolve and produce a chemical called 2,4,-diamino toluene (TDA), which has been linked to an increased risk of breast and other cancers in rats and mice.
To address this issue, this study will gather information from the medical records and a questionnaire survey of approximately 12,000 breast implant patients. The questionnaire will request information on perceived complications of the implants; history of breast examinations and mammograms; frequency of breast self examination; development of diseases (particularly cancers and connective tissue disorders) developed subsequent to the augmentation surgery; potential risk factors for these diseases, such as age at menarche (onset of menstruation), age at first birth, age and type of menopause (natural or due to surgery); history of breast biopsies; immune system and connective tissue disorders; cigarette smoking; alcohol consumption; family medical history, and so forth. To evaluate the results, the information will be compared with the same data on 4,000 women who underwent other plastic surgery procedures, such as rhinoplasty, facelift, liposuction, dermabrasion, eyelifts, and others, from the same practices as the breast augmentation patients.
Participants will be recruited for the study from several large reconstructive and plastic surgery practices. Among the breast implant patients, women who have had bilateral breast implants for cosmetic purposes only, and not as breast reconstruction after breast cancer surgery, will be eligible. Women with a history of breast cancer may not participate.
|Condition or disease|
|Brain Cancer Breast Cancer Lung Cancer Suicide|
|Study Type :||Observational|
|Actual Enrollment :||17424 participants|
|Official Title:||Extended Mortality Follow-Up of Women With Augmentation Mammoplasty|
|Actual Study Start Date :||January 10, 2003|
|Actual Primary Completion Date :||July 10, 2020|
|Actual Study Completion Date :||July 10, 2020|
Women receiving implants and other plastic surgery.
- No intervention [ Time Frame: Indefinite ]Assessing effect of augmentative breast surgery upon breast cancer risk.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342953
|United States, Maryland|
|National Cancer Institute (NCI), 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Robert N Hoover, M.D.||National Cancer Institute (NCI)|