Saline Implants and Connective Tissue or Autoimmune Diseases

Diana Zuckerman, PhD, The National Center for Health Research

Do saline breast implants cause the symptoms known as “breast implant illness?” Joint pain, mental confusion (“brain fog”), exhaustion, hair loss, dry eyes, depression, and “flu-like symptoms that never go away” are just a few of the commonly reported health problems that seem to be caused by connective tissue or autoimmune disorders. However, plastic surgeons, breast implant manufacturers, and others continue to say that breast implants are “proven safe” and that there is no evidence that these symptoms are caused by breast implants.

One argument is that a report of the prestigious Institute of Medicine (IOM) concluded that implants weren’t proven to cause connective tissue diseases. That often quoted report was published in 1999, at a time when there were very few studies of breast implants, and most of the studies were poorly designed. The purpose of this article is to describe the studies of women with implants that were the basis of the IOM report, to help illustrate the shortcomings of those studies

The studies fall into two major categories; cohort studies and case-control studies. Cohort studies compare women who have received breast implants to those who have not, and compare the incidence of illness in the two groups. Case-control studies compare women suffering from a particular disease to those who are healthy and determine whether breast implants are more common in the ill women.

Cohort Studies

Edworthy et al., 1998
Design: Cohort study of breast implant recipients.
Does study include saline implants? YES
If so, how many? 352 of 1576
Were saline implants analyzed separately? NO
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Friis et al., 1997
Design: Cohort study of breast implant recipients.
Does study include saline implants? unclear
If so, how many? 16% had unspecified types of implants
Were saline implants analyzed separately? NO
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Gabriel et al., 1994, “Mayo Clinic Study”
Design: Cohort study of breast implant recipients.
Does study include saline implants? YES
If so, how many? 95 (5.2%)
Were saline implants analyzed separately? NO
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Giltay et al., 1994
Design: Cohort study of breast implant recipients.
NO saline implants.

Hennekens et al., 1996, “Harvard Women’s Health Cohort Study”
Design: Cohort study of breast implant recipients.
Does study include saline implants? Probably
If so, how many? unknown
Were saline implants analyzed separately? NO
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Nyren et al., 1998
Design: Cohort study of breast implant recipients.
Does study include saline implants? YES
If so, how many? 24% of a random cohort within the study
Were saline implants analyzed separately? NO
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Park et al., 1998
Design: Cohort study of breast implant recipients.
NO saline implants.

Sanchez-Guerrero et al., 1995, “Harvard Nurses’ Study”
Design: Cohort study of breast implant recipients.
Does study include saline implants? YES
If so, how many? 170 of 1183
Were saline implants analyzed separately? YES
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Schusterman et al., 1993
Design: Cohort study of all breast cancer patients who had reconstruction.
NO saline implants.

Weisman et al., 1988
Design: Cohort study of cosmetic breast implant recipients.
NO saline implants.

Wells et al., 1994
Design: Cohort study of cosmetic breast implant recipients.
NO saline implants.

Case-Control Studies

Burns et al., 1996
Design: Case-control study of women with scleroderma.
Does study include saline implants? Only two subjects had implants – one had saline (both were controls without scleroderma).
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Goldman et al., 1995
Design: Case-control study of women with rheumatoid arthritis and connective tissue disease.
Does study include saline implants? YES
How many: 4% saline, 11% unspecified.
Were saline implants analyzed separately? NO
Does the study specifically analyze breast cancer patients receiving saline implants? NO

Hochberg et al., 1996
Design: Case-control study of women with scleroderma.
NO saline implants.

Strom et al., 1994
Design: Case-control study of women with lupus.
NO saline implants.

Williams et al., 1997
Design: Case-control study of women with connective tissue disease.
NO saline implants.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.