FDA Approves New Breast Implants: Natrelle Style 410 Form Stable Implants

The FDA approved the Natrelle style 410 shaped, form stable implant today after a pivotal study supported approval of the device. In a recent article published in the Aesthetic Surgery Journal, G. Patrick Maxwell, et al., reviewed the core study at 6 years. The results of this study showed that the next generation form stable type 410 implants may offer surgeons more choices and better control of certain patients breast tissues. This custom fit technique can allow different choices aesthetically in which the breast can actually be changed in shape as opposed to just enlarged. The study followed 941 patients for over six years and demonstrated the new implants are associated with a high degree of satisfaction and an extremely low complication rate.

The study followed women whose average age was between 36 to 52 years old. Among the study groups were women seeking primary breast augmentations, revision breast augmentation, breast reconstruction, and revision breast reconstruction. The patients were very good with their follow up allowing for some very interesting conclusions. One of the most interesting of the conclusions was that the new implants showed a lower rate of hardening than any other silicone implant on the market today. Satisfaction rates were among 95% for the woman seeking primary breast augmentation. The 410 style is available with a wide variety of configurations. The implant can be ordered in a variety of heights, widths and projections allowing the surgeon and patient to have more options. This 5th generation implant differs from current implants in that it is not round and has more stiff silicone gel.

While this implant may offer a leap forward for some patients they must proceed with caution. At Bortnick Plastic Surgery, Dr. Bortnick has performed many thousands of cosmetic breast augmentations. Using the new implants will provide a greater challenge for many surgeons. The use will require surgeons to utilize very specific techniques in patient evaluation, implant selection criteria, and very precise operating techniques. The potential for rotation of the implant and movement of the implant makes the hand to glove fit and the matching of implant size to implant pocket vital. There is very good evidence that the implants have a lower rate of wrinkling than their competitors from Sientra and Mentor. However, be cautioned that there is always that risk. Perhaps the most important feature of the new implant is that in an upright position the gel of the implant does not loose its shape. Often times the 4th generation implants would collapse in the center therefore not allowing the implant to have the same degree of breast shape enhancing attributes.

The surgery utilizing these implants will be performed in the same fashion as with all previous implants. However, the incision that will allow placement of this implant can only be through the inframammary placement, not under the arm or around the nipple. The cost of the implant will be higher than that of the other products. Although exact prices are not known now, expect them to be approximately $500 higher than other silicone implants. As with all surgeries safety and planning and techniques remain the most important factors in a successful outcome. Call (913) 754-4939 for more information.