Saline breast implants leaking
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A leaking breast implant might pose a considerable health danger to any affected woman. Breast implants are not designed to last forever and are likely to fail at some point during their lifespan. Depending on the type of implant, damage or aging might cause the outer shell to rupture completely or simply leak slowly. Women must be prepared to recognize the signs of an implant leak and have the courage to seek immediate treatment if they suspect anything to be wrong with their prostheses. This report helps women to understand the different varieties of breast implant leaks, as well as what to do if they are affected by this frightening condition.
U.S. Food and Drug Administration
Saline Implants & Mold - Breast Implant Illness
All types of breast implants have an outer, silicone shell that can potentially develop a tear or hole called a rupture. A saline implant also has a valve that can fail, causing a leak. The chance that your implant will rupture or leak increases over time. Implant rupture can happen because of normal aging of the implant, trauma caused by a car accident, a needle insertion during a biopsy, or other factors. When a saline implant ruptures or its valve fails, the saline leaks out quickly — typically over the course of a few days — and the breast appears somewhat deflated, so you know immediately that it's ruptured. The salt water is absorbed by the body. When a silicone implant ruptures, the gel leaks out more slowly because it's thicker, so it may take you longer to realize that the implant has ruptured, or you may not realize it at all.
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Breast Implant Rupture
The draft guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication , provides recommendations for the form and content for certain labeling information for saline and silicone gel-filled breast implants, including:. When final, the recommendations in this guidance will supplement or, in some cases, replace recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance , issued November 17, This draft guidance will be open for public comments for 60 days, through December 23, , at www. Submit Comments.
Saline and silicone gel breast implants are designed to last for many years. However, they will not last forever. The silicone shell that holds the saline and silicone gel solution will eventually wear out, resulting in small leaks, complete deflation, or otherwise ruptured implants.
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