Study of Health Effects of Cosmetic Breast Augmentation

NCT00342953 | Completed

• 2 other identifiers: 99990308203-C-N082
• Study Type: observational
• Target: 17,424
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Cancer; Breast Cancer; Lung Cancer; Suicide

Keywords

saline; silicone; Breast Implants; augmentation mammoplasty; visk

Outcome Measures

Primary Outcomes (1)

• No intervention

  Assessing effect of augmentative breast surgery upon breast cancer risk.

  Indefinite

Study Arms (1)

Cohort

Women receiving implants and other plastic surgery.

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

13,488 women receiving cosmetic implants and 3,936 patients who had other types of plastic surgery at 18 plastic surgery practices during the period 1960-1988.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Baldwin CM Jr, Kaplan EN. Silicone-induced human adjuvant disease? Ann Plast Surg. 1983 Apr;10(4):270-3. doi: 10.1097/00000637-198304000-00002.

  PMID: 6847084 BACKGROUND

• Benavent WJ. Treatment of bilateral breast carcinomas in a patient with silicone-gel breast implants. Case report. Plast Reconstr Surg. 1973 May;51(5):588-9. doi: 10.1097/00006534-197305000-00026. No abstract available.

  PMID: 4349607 BACKGROUND

• Ashley FL. A new type of breast prosthesis. Preliminary report. Plast Reconstr Surg. 1970 May;45(5):421-4. doi: 10.1097/00006534-197005000-00001. No abstract available.

  PMID: 5438186 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Lung Neoplasms; Suicide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Robert N Hoover, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: January 10, 2003
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)