The Natrelle® Collection from Allergan, Inc. is a product line of silicone gel-filled and saline-filled breast implants, approved by the FDA that range in volume, shape, texture, and implant filler – saline or silicone gel – providing you and your surgeon an array of options to achieve a personalized result that is in line with your expectations of surgery. For more detailed information about breast implants, please read the complete patient information at http://natrelle.com/safety_info.html.
FDA Approved Saline-Filled Breast Implants:
Silicone Shell with Liquid Saline-Filler
Saline-filled breast implants were approved by the FDA in May 2000. Saline filled breast implants have a silicone shell and are filled with sterile saline (salt water). During breast implant surgery, the shells are placed inside a woman’s body without the fluid inside, and then filled to achieve the desired result.
FDA Approved Silicone-Gel Filled Breast Implants:
Silicone Shell with Cohesive Gel-Filler
Natrelle® silicone-filled breast implants have been used with success for more than 25 years in over 60countries, and they were approved by the US Food and Drug Administration (FDA) in November 2006. The safety of Natreller silicone-filled breast implants is supported by extensive pre-clinical device testing, their use in approximately 1,000,000 women worldwide and nearly a decade of US clinical experience involving more than 80,000 women.
Like many other medical devices on the market today, silicone gel-filled breast implants have evolved over the last two decades. Today’s Natreller silicone-filled breast implants have an advanced technology and enhanced safety profile due to several refinements in product design and manufacturing, including a more cohesive silicone gel. Today’s Natreller silicone-filled breast implants also have a thicker shell, which contains an additional barrier layer that is distinct from earlier breast implant devices and is designed to withstand more than 25 times the force of a normal mammogram without failure.
Proven Safety of Silicone Gel-Filled Breast Implants
Arguably, silicone gel-filled breast implants are among the most studied FDA approved medical devices in existence. There have been hundreds of peer-reviewed and published reports on studies involving silicone gel-filled breast implants, including robust epidemiology studies supporting their use. As discussed earlier in the chapter, the Institute of Medicine of the National Academies (IOM, 1999) that “a review of the toxicology studies of silicones and other substances known to be in breast implants does not provide a basis for health concerns.” More information about the safety of silicone gel-filled implants can be found in the IOM report at http://www.iom.edu/CMS/3793/5638.aspx or for more detailed information about breast implants, please read the complete patient information on the Natrelle® website.
Key Attributes of Natrelle® Silicone-Filled Breast Implants Include:
- Low Long-Term Rupture Rates: To help assess the long-term safety of its breast implants, Allergan conducted extensive clinical studies both in the United States and in Europe. These studies show that silicone-filled implants have low long-term rupture rates. In fact, the results of the European research found that after 11 years, 92% of implants were still intact.
- Rigorous Testing: Breast implants from the Natrelle® Collection undergo thorough testing to meet Allergan’s high quality standards. Pre-clinical testing of Natrelle® silicone-filled breast implants show that they are designed more than 25 times the force of a normal mammogram without failure.
- Ongoing Research: Through ongoing research Allergan is constantly assessing its devices’ impressive long-term safety record.