Minneapolis Breast Augmentation: FDA Approves New Type of Silicone ImplantPublished on March 3, 2013 by Hoffman, James
As of February 20, 2013, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant is officially approved by the U.S. Food and Drug Administration (FDA) for breast augmentation and reconstruction. Natrelle, the 4th silicone implant approved by FDA, is currently manufactured by Allergan, Inc. To determine if you’re a suitable candidate for the Natrelle 410 implant, schedule an Minnesota breast implant consultation with Dr. James Hoffman.
According to its manufacturer, the Natrelle implants contains more cross-linking (more bonds linking one silicone chain to the other) than its earlier counterparts, thus making the newly-approved implant firmer. The FDA approval was a result of a series of studies for 7 years which looked at 941 women using Natrelle 410 implants.
Post-Approval Studies Required
After the approval, Allergan is required by the FDA to conduct a series of studies focusing on the effectiveness, long-term safety and risks of the Natrelle implants. The required studies should focus on the following:
- a follow-up study after 5 years on 3,500 women who had the Natrelle implants before the FDA approval
- a follow-up study after 10 years on 2,000 women who had the Natrelle implants after the FDA approval
- five studies figuring out if there are links between the Natrelle implants and the following 5 diseases: lymphoma, vulvar/cervical cancer, brain cancer, neurological disease, rare connective tissue diseases
- a study collecting and analyzing information related to implants that are removed and returned to the manufacturer
- a study looking at how women perceive the labeling of the implant
Ideal Candidates for Natrelle Implants
The stability in its form and cohesiveness make Natrelle implants ideal for:
- women at risk of capsular contracture
- women with less breast tissue cover
- women needing breast reconstruction
Every woman’s needs and concerns for Woodbury breast augmentation are unique thus a consultation with Dr. Hoffman will help you carefully decide on your breast implant alternatives. Contact us at 651.686.4548 or fill out this online contact form to schedule an appointment with Dr. Hoffman. We look forward to your visit!