Although silicone gel breast implants were banned in the US for safety and complication reasons, they continued to develop in other countries. Late 1980s saw the introduction of third-generation silicone gel implants with reinforced shells and additional barrier layer. These implants featured additional barrier layer to reduce gel bleed, a phenomenon that occurs when low molecular weight silicone oil diffuses through an elastomer shell. In addition, textured surface implants were developed to decrease CC rates, imitating biomechanical effects of a polyurethane cover.
Although there is no evidence of any significant difference between silicone gel-filled and empty breast implants, there are risks of autoimmune diseases and inflammation associated with these treatments. In one study, women with silicone gel-filled implants were eight times more likely to develop rheumatoid arthritis, Sjogren’s syndrome, or mixed connective-tissue disease. The study results were mixed and some cases were not reported by physicians.
The new study is the first to document the risks associated with various types of silicone breast implants. Its authors hope that these datasets will help improve silicone breast implants and other types of medical silicone. The authors of the study are Marcos Sforza, Tracy Ann Perry, Jennifer Haupt, Morgan Jamiel, Amanda Nash, Stuart Bauer, Sarah Neshat, and Mark Clemens. The researchers are supported by the Establishment Labs.
One study of 80 women with silicone breast implants published in a peer-reviewed journal found that many of them suffered from systemic illnesses. These systemic illnesses affect the whole body. Most of these women reported symptoms of muscle and joint pain, fatigue, and night sweats. The study also found that despite these side effects, two-thirds of the women improved after the implants were removed. Researchers suggest that the cause of the symptoms may be related to autoimmune reactions that the silicone implants trigger.
Better esthetic results
Silicone gel implants offer a greater range of shapes, sizes, and projections than conventional silicone implants. In the US, they are available in limited quantities. Allergan offers five different projections and smooth surfaces. Mentor offers three different projections and sizes. The anatomic silicone gel implant is available for study use only. It’s also more expensive than traditional implants. But the resulting shape can still provide better esthetic results than natural ones. Learn more about Tampa Plastic Surgeon Ernesto J Ruas MD.
The FDA imposed restrictions on the use of saline implants in the US in the early 1990s. But development continued in other countries. In the late 1980s, the FDA required a formal evaluation of the safety and efficacy of saline implants. During this time, the FDA required refinements in the manufacturing process, including tighter specifications, lower tolerances for variability, and improved quality control. The fifth-generation implants were introduced in Europe in 1993.
In addition to the lower risk of rupture, silicone implants feel more natural and don’t ripple like their saline counterparts. As a result, they’re better for women with thin bodies and smaller busts. The edges of silicone implants are less noticeable and accentuate the shape of the body. Moreover, silicone implants can help you get a smaller incision than their saline counterparts.
Safety of silicone gel-filled implants
The FDA approved the use of highly cohesive silicone gel-filled breast implants in 2006. After these implants received approval from the FDA, manufacturers were required to conduct post-approval studies to ensure their safety and effectiveness. The FDA’s assessment of the implants’ safety and effectiveness included data on adverse events and recent scientific publications. The FDA approved the use of silicone gel-filled breast implants for breast augmentation and replacement procedures in women of all ages. The company was required to conduct six post-approval studies.
Despite the widespread opposition, the safety of silicone gel-filled breast implants is largely assured as long as the implants are used properly and in the proper way. While silicone gel-filled implants are generally safe, women should be aware of the risks associated with their use, such as capsular contracture and implant rupture. For this reason, the FDA released a report on breast implants in 2006.
The report found no connection between silicone implants and reproductive problems or connective tissue disease. However, the report highlights rare reports of Anaplastic Large Cell Lymphoma. As of this writing, the most reliable method of detecting silent rupture of silicone gel-filled breast implants is MRI. While there are no definitive data indicating the risk of breast cancer from silicone gel-filled breast implants, patients should seek medical advice before undergoing this procedure.