Saline implants surgery

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Saline Implants
Since silicone gel implants were banned by the FDA in 1992, saline implants have been available for both cosmetic and reconstructive breast surgery. In 1989, the FDA classified saline breast prostheses as a class III device, the category designated for implantable devices that lack sufficient data to demonstrate safety and efficacy. As a result of this ruling, saline implants will need to undergo extensive governmental and scientific scrutiny before they can be approved. Satisfied that study enrollment levels were met by organized plastic surgery in 1995, the FDA has allowed the continued unrestricted use of saline implants but cautions that a final determination will be made when the study results have been reported.

Current rates of deflation are considered to range from 1% to 3% over an 8-year period for the newer models of saline breast prostheses. In contrast, when rupture and aging of silicone gel implants were studied retrospectively, all devices older than 10 years showed evidence of either leakage or outright rupture. This clear message of obsolescence in silicone implants indicates a need for increased surveillance of any aging prosthesis.

Content of a saline
Although the content of a saline implant is presumed to be sterile, recent health concerns have arisen following reports of contamination of the saline contents. A multitude of bacterial and fungal microorganisms have been recovered, but the incidence of infection of saline implants is extremely low at about 1% to 2%37. Contamination of these devices may represent rare growth, indicating only the occasional presence of microbes in extremely small numbers.

DETECTION OF BREAST CANCER AND SURVIVAL IN AUGMENTED WOMEN

Do women with breast implants who are subsequently diagnosed with breast cancer suffer any delay in diagnosis or have a worsened prognosis as compared to breast cancer patients without implants? This important question was raised following earlier evidence that implants can obscure mammary lesions or make physical examination of the breast more difficult, delaying proper diagnosis.

Physical Features
Like any water-filled devices, saline implants manifest surface irregularities characterized by waves and ripples. These surface features can be visible clinically, particularly when soft tissue coverage is inadequate. To avoid this problem, subpectoral placement has been promoted, along with complete filling of the implant. Still newer models have anatomic designs that mimic the lower pole curvature and upper pole fullness of normal breast anatomy

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