Nothing is more important to than your long-term health and safety. That\'s why breast implants from the Natrelle Collection undergo a unique battery of tests to ensure their innovative design meets Food and Drug Administration (FDA), United States and International standards, as well as Allergan\'s high requirements for quality.
To help track the long term safety of our breast implants, we have conducted extensive clinical studies, both in the United States and in Europe. These studies show that Allergan\'s Natrelle silicone filled breast implants have low long term rupture rates. In fact, the results of the European research found that, even after 11 years, 92 percent of all implants were still intact.
Natrelle silicone filled breast implants are designed with our patented patch design with 360 degree barrier layer coverage, which provides extra protection against gel diffusion or movement. To test their strength, empty shells are stretched to ensure patch joints remain intact. To date, Natrelle breast implants have not failed in testing, and no implant failures due to patch defects have been reported.
Breast implants filled with a cohesive gel are less likely to leak or ripple, providing a natural feel and shape. Allergan regularly conducts tests to measure the cohesivity of our implants. The silicone gel used to fill Natrelle breast implants consistently exceeds Food and Drug Administration (FDA) guidelines for cohesivity.
A routine mammogram exerts approximately 30 pounds of force on a woman\'s breast. In addition to FDA required testing, Allergan\'s testing exerts far greater force, and found the silicone gel filled breast implants in the Natrelle Collection can absorb 25 times the force of a mammogram without failure.
Our dedication to research doesn\'t stop once we make our implants. Our Breast Implant Follow up Studies (BIFS), for example, help Allergan add to the already extensive safety data gathered on our products. One of the largest clinical studies ever undertaken, over 40,000 women will have participated over the course of 10 years when complete.
Silicone gel filled breast implants are widely studied medical devices. In addition to our research, thousands of peer reviewed and published reports on breast implants, including robust epidemiological studies, support their safe use.
Natrelle saline filled breast implants have also been heavily researched and are FDA approved. Post market surveillance data shows that out of nearly one and a half million Natrelle saline filled breast implants, more than 97.5 percent remained intact after ten years. In addition, we regularly test the durability of our saline filled implants according to standards set forth by the FDA.