- There appears to be little scientific basis for any association between implant rupture and well-defined connective tissue disease or undefined or atypical connective tissue diseases.
- The concept of silicone-related disease was developed by rheumatologists based on highly selected groups of symptomatic breast implant patients seen in their practices.
- It is likely that nonspecific complications or symptoms related perhaps to capsular contracture or implant rupture may be misinterpreted as representing a systemic disease.
Silicone Implants and Breast Cancer
- The majority of studies report somewhat lower breast cancer incidence and mortality among implant patients. A comprehensive literature search and meta-analysis published in 2001 summarized results from 10 studies available at that time and estimated the relative risk for breast cancer as 0.72 (95 percent confidence interval, 0.61 to 0.85).
- There are clear reasons for concern that implant patients may experience delayed detection of breast cancer and poorer prognosis. Nevertheless, using stage at diagnosis and tumor size as indicators of detection delay, no consistent evidence of delay or decreased survival has been found.
- It is well-established that the silicone devices are radiopaque and obscure some portions of breast tissue from mammographic visualization, which may increase the risk of late detection. [One of the reasons for the FDA recommendation that these patients have periodic MRI's.]
- The risk of a local and distant recurrence of breast cancer was 50 percent of expected, a non-significant difference, and the risk of secondary breast cancer was no different from expected.
- No difference in the breast cancer mortality experience has been found.
- A recent study revealed that there was no significant difference in the levels of silicone in breast milk and blood between two groups of women. One group of women was breast-feeding with silicone implants, whereas the group breast-feeding without silicone implants acted as a control group.
- Mothers with silicone implants may decide not to breast-feed because of the suspected risk of breast milk contamination. The alternative source of nutrition for these infants is a variety of commercially available formulas.
- It is well known that there are sources of silicone in the everyday diet, including its use as an antifoaming agent in fruit juices and other types of food. Infants have been given silicone drops for colic for many years, with no identifiable problems [Mylicon drops (Merck Consumer Pharmaceutical, Ft. Washington, Pa.), used in the United States, have 67 mg of polydimethylsiloxane per milliliter and Miniform, as used in Europe, has 94 mg of polydimethylsiloxane per milliliter].
- Rates of esophageal and rheumatic disorders, congenital malformations, and perinatal mortality and hospitalization were comparable between children born to mothers with breast implants and children born to mothers who had undergone other cosmetic surgery.
- Based on this review, the epidemiologic evidence to date does not support an increased risk to offspring of women with breast implants for health problems such as esophageal and rheumatic disorders, congenital malformations, or perinatal mortality.
Silicone Breast Implants: Outcomes and Safety; Supplement to Plastic and Reconstructive Surgery, Vol 120, No 7, Suppl 1, December 2007
- Breast Implant Rupture and Connective Tissue Disease: A Review of the Literature; Lisbet Rosenkrantz Hölmich, M.D.; Loren Lipworth, Sc.D.; Joseph K. McLaughlin, Ph.D.; Søren Friis, M.D
- Breast Implants and Breast Cancer: A Review of Incidence, Detection, Mortality, and Survival; Dennis Deapen, Dr.P.H.
- The Relationship of Silicone Breast Implants and Cancer at Other Sites; Louise A. Brinton, Ph.D.
- Breast-Feeding and Silicone Implants; John L. Semple, M.D., M.Sc.
- Adverse Health Outcomes in Offspring of Mothers with Cosmetic Breast Implants: A Review; Kim Kjøller, M.D.; Søren Friis, M.D.; Loren Lipworth, Sc.D.; Joseph K. McLaughlin, Ph.D.; Jørgen H. Olsen, M.D., Dm.Sc.