Breast Surgery in South Florida
Breast Augmentation in Boca
Silicone Gel Implants
Many women do not realize that silicone gel breast implants are once again a safe, popular option for breast augmentation surgery. The FDA recently determined that silicone gel-filled breast implants are safe and effective for use in breast enhancement and breast reconstructive surgery.
Silicone breast implants are made from silicon, which is the most commonly found element in the earth's crust after oxygen. Silicone has been used to manufacture everyday products ranging from baby pacifiers to suntan lotions for over 50 years. Aside from being used as breast implant filler, silicone is used in a wide range of medical devices such as artificial joints, catheters, facial implants, tissue expanders, and more.
Numerous tests and clinical studies have proven silicone to be a safe and ideal material for both implantable and non-implantable medical devices. These tests have shown that silicone products are reliable, biocompatible, flexible, and easy to sterilize, making them an ideal choice for breast reconstruction surgery. Silicone gel-filled breast implants have been the subject of literally thousands of studies and reports, and are now among the most researched medical devices.
Silicone gel-filled breast implants have been used extensively in the U.S. and are consistently used in more than 60 countries around the world. In 1992, the FDA called for a voluntary delay on their usage until new safety information could be thoroughly reviewed by the FDA's advisory panel. That same year, the FDA lifted its hold and announced its decision to allow access to silicone gel-filled breast implants for reconstruction patients under controlled clinical studies.
In 1999, the FDA allowed the use of silicone gel-filled breast implants in Allergan's Core Clinical Study, an ongoing 10-year study of women who had breast augmentation, reconstruction, or revision of a previous surgery. Significant research was conducted in order to assess the safety and effectiveness of these devices. Following a successful review of relevant background data and clinical research, the FDA recently approved silicone gel-filled implants, deeming them safe and effective for breast augmentation and reconstruction for women at least 22 years of age.
As a leader in breast aesthetics for 25 years, Allergan is committed to the long-term safety of our breast implants. The silicone gel-filled implants available in Allergan's Natrelle® Collection features a Food and Drug (FDA) approved silicone shell with a cohesive gel-filler. Essentially, the inclusion of this feature means that the silicone inside the implant acts more like a soft solid than a liquid. All silicone gel-filled breast implant manufacturers currently have a consistent testing standard for silicone cohesivity (a combination of softness and firmness that replicates the natural feel of a woman's breast), which is recommended by the FDA.
Silicone gel-filled breast implants are indicated for females for the following uses:
Breast augmentation - For women at least 22 years old, breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
Breast reconstruction- Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
The safety of Natrelle® Silicone-Filled Breast Implants is supported by extensive pre-clinical testing, U.S. clinical studies, a European rupture prevalence study, worldwide experience and peer-reviewed literature. This includes more than 25 years of real-world experience in women in more than 60 countries. In addition, numerous peer-reviewed publications and research demonstrate the safety of silicone and silicone gel-filled breast implants.
For many women, breast implant surgery can be very rewarding, both physically and emotionally. However, as with any elective surgery, it is important to consider the possible risks, as well as the possible benefits, before making your decision. There are many important factors to consider before choosing silicone gel-filled breast implants. Communicating to your surgeon your goals for breast implant surgery is one of the most important steps in achieving the individualized aesthetic result that is right for you, so you look and feel your best.
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