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Silicone gel-filled breast implants have been used for breast augmentation or reconstruction for nearly 3 decades. These implants became the subject of controversy in 1991 when concerns were raised that silicone implants were contributing to or causing autoimmune disorders. These concerns led the Food and Drug Administration (FDA) to institute a voluntary moratorium on the use of silicone breast implants in 1991 and to conclude in 1992 that proof of safety and efficacy had not been adequately established for silicone breast implants. It was recommended that additional controlled clinical trials be conducted to examine the safety of silicone implants for breast reconstruction and augmentation.
There is currently clinical evidence that silicone implants increase the incidence of breast carcinoma. Upon review of the data suggesting a link between silicone implants and collagen vascular disorders. Evidence to prove an association between silicone implants and any autoimmune disorder.
However, more recent reports are again raising the issue of a relationship between silicone implants and autoimmune disorders, with some studies identifying circulating autoantibodies as a variety of connective tissue related peptides, or types I and II collagen, or antinuclear antibodies in women with silicone implants. These new findings indicate the need for additional examination of the relationship between silicone and autoimmune disorders before any widespread use of silicone implants resumes.
A recent small study raised the possibility of a scleroderma-like esophageal motility disorder in breast-fed infants of mothers with silicone implants in place. It has been hypothesized that mother-to-child transmission of silicone or maternal antibodies.
Although the moratorium on the use of silicone implants has been lifted and replaced.
It is recommended that women with saline or silicone implants in place have routine breast examination.
Capsule formation does not, however, create masses or nodularity, and any palpable masses in women with implants should be evaluated with mammography and biopsy of any persistent masses.
Leak or rupture of an implant may be identified as a change in the size or shape of the augmented or reconstructed breast on physical examination or with variable success by ultrasound, mammography, or MRI.