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 ?
On a global scale, approximately 30,000,000 women have breast implants worldwide, (not including breast reconstruction) and there have been approximately 12 deaths worldwide.
Late-term fluid accumulation around breast implants can occur for many reasons, including trauma, infection or malignancy.
Our experience shows that breast implants make it difficult to see the heart with echocardiography because ultrasound cannot penetrate through the implant," said lead author Dr Sok-Sithikun Bun, in a recent (https://www.
This study investigated whether breast implants are associated with abnormal ECG recordings.
The global breast implants market has been segmented on the basis of Product Type (Silicone Breast Implants, Saline Breast Implants); Shape (Round Breast Implants, Anatomical Breast Implants); Application (Cosmetic Surgery, Reconstructive Surgery); End User (Hospitals, Cosmetology Clinics); and Region (North America, Latin America, Europe, Asia Pacific, and MEA).
The register will record the details of every person who has breast implant surgery in case of a product recall or another safety concern.
The company added that NATRELLE INSPIRA Cohesive breast implants have been approved by the US FDA for women undergoing reconstruction, augmentation or revision surgery a new breast shaping option that combines a high gel fill ratio and its highly cohesive gel for a customized result.
Under the measure, to be known as Breast Implant Research and Information Act, the Breast Implant Research Committee shall be created and mandated to give an accurate and complete information to the Secretary of Health with regard the risk of breast implants.
But they added that despite reports and warnings about the possible risks they could face, some women still choose to have breast implants.
In the second meta-analysis of five studies, the overall hazard ratio for breast cancer-specific mortality among women with cosmetic breast implants was 1.
A team of researchers based in Canada wanted to find out whether the stage at which breast cancer is diagnosed - and post-diagnosis survival - differed between women with and without cosmetic breast implants.
In 2011, the recall of tens of thousands of defective breast implants in Europe and the US Food and Drug Administration's (FDA) warnings about the increased risk of a rare lymphoma linked to all breast implants raise questions about the adequacy of safety regulations (1-3) in both places.