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Extended Mortality Follow-Up of Women With Augmentation Mammoplasty

Not Enrolling
Augmentation Mammaplasty

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Trial Information

Extended Mortality Follow-Up of Women With Augmentation Mammoplasty

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
chemicaI2, 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 13,500 breast
implant patients has been conducted. These women were recruited from 18 plastic surgery
practices in six geographic areas. The cohort comprised women with different types of
implants and an average of 12 years of follow-up. Records at the collaborating practices
were 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 was developed and sent
to the study subjects. This questionnaire requested 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 consisted of approximately 4,000 women who received operations from the same
plastic surgery practices as the breast augmentation patients. This comparison groups
consisted of women undergoing a variety of cosmetic plastic surgery procedures not involving
silicone exposure, such as rhinoplasty. Attempts were made to assemble this cohort with
similar ages and operations dates as the breast implant patients. Records of these patients
were 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.

Inclusion Criteria


The following criteria for inclusion in the study cohort will apply:

1. Age. No age restrictions apply; patients receiving cosmetic implants at any age will
be eligible for study.

2. Cosmetic augmentation only. Patients with breast reduction surgery or reconstructive
surgery following breast cancer will not be included.

3. Females only. Implants in conjunction with sex change surgery will not be included.

4. Bilateral implants only. Patients with unilateral implants will not be included.

5. First occurrence of a breast implant. Patients with a previous breast implant will
not be included.

6. Patients with a history of plastic surgery involving silicone exposure will not be

7. Patients with a history of breast cancer at or before the time of implant will not be

8. 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).

9. 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.

Type of Study:


Study Design:


Principal Investigator

Louise Brinton, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Augmentation Mammaplasty
  • Breast Implants
  • Risk
  • Breast Cancer
  • Brain Cancer
  • Lung Cancer



National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland  20892