Study of Health Effects of Cosmetic Breast Augmentation
Condition: Brain Cancer; Breast Cancer; Lung Cancer; Suicide
MeSH terms: Brain Neoplasms; Suicide
Study type: Observational

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.
    

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 of implanted material on the immune system. In addition, there has
      been a long-standing concern that breast implants may deter the detection of breast cancers.
      More recently, concern has developed over the possible carcinogenicity of the material used
      in implants themselves. Of particular concern is the recognition that a polyurethane foam
      coating used to contain silicone gel in some implants is comprised of the chemicaI 2,
      4-diamino toluene, or TDA, which has been linked to increased risks of breast as well as
      other cancers in rats and mice. To address these concerns, a retrospective cohort study of
      approximately 12,000 breast implant patients is proposed. It is anticipated that these women
      will be recruited from a number of large reconstructive and plastic surgery practices in
      several diverse areas. The cohort will be constructed in such a manner that a variety of
      different implant types are represented and an average of 10 years of follow-up on the
      patients is achieved. Records at the collaborating practices will be reviewed to obtain
      identifiers of potential study subjects, particulars of the surgery and possible co-variates
      for subsequent diseases. Using a variety of sources, the subjects were traced for current
      vital status and residence. A questionnaire will be developed and sent to the study subjects.
      This questionnaire will request information from the subjects on perceived complications of
      the implant, history of breast examinations and mammograms, frequency of breast self
      examinations, development of diseases subsequent to the operation (with particular interest
      on cancer and connective tissue disorders), and potential risk factors for the diseases of
      interest (e.g., age at menarche, age at first birth, age and type of menopause, family
      medical history, immune alterations). Because of difficulties in comparing this population to
      an external standard, an internal comparison cohort was also assembled. This will consist of
      approximately 4,000 women receiving operations from the same plastic surgery practices as the
      breast augmentation patients. This comparison group will consist of women undergoing a
      variety of cosmetic plastic surgery procedures, such as rhinoplasty. Attempts will be made to
      assemble a cohort with similar ages and operations dates as the breast implant patients.
      Records of these patients will be abstracted and follow-up pursued in the same manner as for
      the mammoplasty patients. The cancer incidence and mortality experience of the augmentation
      mammoplasty patients was compared to both general population rates (using SEER cancer
      incidence and U.S. mortality rates) and to that of the experience of the other plastic
      surgery patients. Analyses of the risk of connective tissue disorders focused solely on the
      internal comparisons, given the absence of available population incidence rates for these
      disorders. Analyses included efforts to assess risks by various implant characteristics,
      including age at, calendar time of, and interval since implantation. Internal analyses
      enabled adjustment for recognized risk factors, particularly for the cancers of interest.
    

Observational model: Cohort
Time perspective: Retrospective
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.
      
Keywords: saline; silicone; Breast Implants; augmentation mammoplasty; visk