On February 20, 2013, the FDA approved the Natrelle 410 highly cohesive anatomically shaped silicone implant. Candidates for implantation must be at least 22 years of age or have undergone reconstruction after treatment for breast cancer.
The new Natrelle 410 implants containing more cross-linking compared to silicone gel used in other implants. The increased cross-linking results in a silicone that is firmer. Although these the new implants may not be appropriate for all patients, it’s nice to have additional options to give the consumer a broader choice.
The FDA has based its approval on a study of over 941 women who received the implants and followed them over 7 years. Most complications and outcomes were similar to those found in previous breast implant studies including capsular contracture, reoperation, asymmetry, implant removal and infection. In addition, investigators found fissures or cracks in some of the Natrelle 410 implants. This “gel fracture,” as it is referred to, is unique to this implant.
I always remind patient’s that breast implants are not lifetime devices. I counseled my patients the patient fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery. Long-term monitoring of these and all implants is essential.
I hope this new information helps.