"Surgeons should look at implanting the 410 style implant as a brand new procedure similar to when they did their first SMAS facelift versus a skin-only facelift. The dissection is different, the anatomy is different and the results are different," according to Dr. Bengtson, who reported his phase 3 clinical results on 224 of the new implants — the largest current series with the Style 410 in the United States.
According to Dan Cohen, vice president, Inamed Corp., the Style 410 was not part of the premarket approval application (PMA) for Inamed's responsive silicone breast implant, which failed to win recommendation from a U.S. Food and Drug Administration (FDA) advisory panel in April (see related story, cover). The PMA application for the Style 410 implant was submitted to the FDA in December and is still under consideration, Mr. Cohen says.Different requirements The Style 410, which is marketed internationally as the Bio-dimensional Cohesive-Gel Matrix, requires a hand-in-glove pocket dissection, with the incision best placed through an inframammary incision.
"The implant is textured, form-stable, holding its shape in all positions, and being shaped, it has to be placed perfectly vertically in the pocket," Dr. Bengtson says. "If you stick with the techniques that you're used to using with smooth, round saline or silicone implants you may find yourself in trouble. The implant has to fit the pocket perfectly so that it doesn't shift or rotate."
The procedure must be performed completely bloodless. "If there's no bleeding then not only can recovery be fast-tracked, but there's a decreased risk of hematoma or seroma that could allow the implant to shift or rotate," he explains.
Outcomes With an average 28 month follow-up (six to 40 months), no patient in the Style 410 series has required re-operation for implant-related complications. There have been no infections, no hematomas, no malpositions or rotations and no major Baker III-IV operative capsulectomies. Complications included four unilateral mild Baker II capsular contractions, two small superior pole seroma/hematomas that resolved and two 1.0 cm lateral skin dehiscence, which were closed. The only re-operations in the series were three patients, among the first 24, who elected to have a size change, and three patients who required repeat mastopexy for recurrent ptosis.
"I tell my patients that my goal for their breast augmentation is to put in the largest breast implant possible that's proportional to their breast and to their body to minimize the number of re-operations, for the implant to last as long as possible with the best cosmetic outcome with minimal complications," Dr. Bengtson says. "This implant really satisfies these goals better than any other. It's the best cosmetic result from the standpoint that it has the least edge palpability, it has no palpable wrinkling or rippling and it is soft, and with its low capsular contraction rate also softens with time. Style 410 breasts are so soft that they appear and feel natural in the vast majority of cases," he adds.