breast implant


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breast implant,

saline- or silicone-filled prosthesis used after mastectomymastectomy
, surgical removal of breast tissue, usually done as treatment for breast cancer. There are many types of mastectomy. In general, the farther the cancer has spread, the more tissue is taken.
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 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., lupuslupus
, noninfectious chronic disease in which antibodies in an individual's immune system attack the body's own substances. In lupus, known medically as lupus erythematosus, antibodies are produced against the individual's own cells, causing tissue inflammation and cell damage.
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, arthritisarthritis,
painful inflammation of a joint or joints of the body, usually producing heat and redness. There are many kinds of arthritis. In its various forms, arthritis disables more people than any other chronic disorder.
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, 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.

Bibliography

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

References in periodicals archive ?
Higher follow-up rate than any previous FDA breast implant clinical trial, so the clinical data is significant and meaningful.
The report reviews the basic information of Breast Implant including its classification, application and manufacturing technology.
PIP saline-filled breast implants were cleared by the FDA in 1996, based on the company's evidence that their device was "substantially equivalent" to another breast implant already on the market.
There have been roughly 60 cases of ALCL in women with breast implants worldwide, according to the FDA.
Doctors expressed concern that merely introducing a levy on Botox or breast implants would open the door to other taxes in the medical industry.
Why is access to silicone gel-filled breast implants presently restricted?
I received hundreds of calls from women across the nation who were ready to consign themselves literally to insane asylums," they were so upset when they heard that breast implants might be linked to serious health problems, she said.
The controversy over breast implants is used as a case for this shift in the burden of proof of safety and effectiveness.
410 Shaped Gel Breast Implants are filled with a highly cohesive silicone gel which enables the implants to have long-lasting shape over time.
Moreover, the Breast Implant Safety website (<www.
These studies provide reassurance that the risk of developing a typical or defined connective tissue disease due to a breast implant is not high.
We have great concerns that any medical device with silicone in it will not survive," says Elizabeth Connell, a professor of gynecology and obstetrics at Emory University and head of two Food and Drug Administration silicone breast implant panels that unsuccessfully recommended leaving the devices on the market.