Study of Health Effects of Cosmetic Breast Augmentation

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.

- INCLUSION AND EXCLUSION 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
included.

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

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.