breast implant

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breast implant

breast implant, saline- or silicone-filled prosthesis used after mastectomy as a part of the breast reconstruction process or used cosmetically to augment small breasts. An implant consists of a fluid-filled, malleable pouch that is designed to mimic to the look and feel of natural breast tissue when inserted into a pocket created under the skin in a procedure called a mammoplasty.

After reports that leakage from silicone-filled implants might be causing autoimmune diseases (e.g., lupus, arthritis, scleroderma) in some women, the Food and Drug Administration in 1992 called for a moratorium on their use outside clinical trials. The ensuing scare resulted in the largest product liability settlement in U.S. history and the Chapter-11 bankruptcy of Dow Corning Corporation, one of the makers of the implants. Despite legal settlements in the billions of dollars, the claims against silicone-filled implants remain anecdotal; numerous scientific studies have found no link or only a weak equivocal link between the implants and disease. The use of silicone-filled implants was again approved by the FDA for reconstructive surgery in 1998 and for cosmetic surgery in 2006.

In 2010 silicone-filled implants manufactured by the French company Poly Implant Protheses (PIP) were banned after it was discovered that the firm had used industrial-grade, instead of medical-grade, silicone gel. Industrial-grade silicone has more contaminants, and French authorities advised (2011) that French women have the implants removed because they were believed to have a higher than normal incidence of rupture. Some countries adopted similar recommendations, while others did not; the implants had not been licensed for use in the United States. A 2012 British report on the PIP implants found that the gel used in them did not constitute a long-term health threat.


See M. Angell, Science on Trial (1996).

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References in periodicals archive ?
Breast cancer after augmentation mammoplasty. Ann Surg Oncol.
The first clinical study, LANTERN-1, one of two Phase 2 clinical studies, is a placebo-controlled, double-blind ascending dose cohort trial to evaluate the safety and efficacy of EB-001 intramuscular injections in subjects undergoing elective augmentation mammoplasty (breast augmentation).
Augmentation mammoplasty for cosmetic enlargement was first attempted in the 19th century, leading to development of the first silicone gel implant in 1962.
abscessus has been associated with a variety of infections including skin and soft-tissue infections (following puncture wounds or inoculations), pulmonary infection, infections related to foreign material (e.g., porcine and prosthetic cardiac grafts, prosthetic joints, intravenous and dialysis catheters, tympanoplasty tubes, and augmentation mammoplasty), and postsurgical infections (e.g., sternal wound) (1).
Augmentation mammoplasty: a new "natural feel" prosthesis.

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