The IDEAL breast implant may really be the best of both worlds, according to two-year clinical data.
The IDEAL IMPLANT is a novel, double-lumen, saline-filled breast implant. After two years, both women who received the IDEAL IMPLANT and their surgeons reported high rates of satisfaction, a low rate of wrinkling, and a lower rate of capsular contracture compared to current, single-lumen, saline-filled implants. The findings appear in the September issue of the Aesthetic Surgery Journal.
“The two-year clinical data from this study show that the IDEAL IMPLANT may provide a good alternative to current saline- or even silicone gel-filled implants,” says study co-author and clinical trial investigator Larry S. Nichter, MD, in a press release. He is voluntary clinical professor of plastic surgery at University of Southern California and University of California, Irvine and the Chairman of the department of plastic surgery at Hoag Memorial Hospital in Newport Beach, California. “One of our most significant and unexpected findings was the low rate of capsular contracture for the investigational, double-lumen implant compared to current single-lumen saline implants.”
The IDEAL IMPLANT comprises a baffle structure, two lumens, and a series of shells of increasing size nested together. This design is meant to better control saline movement and provide internal support to the implant edge and upper pole. This device is being investigated in a 10-year, U.S. clinical trial evaluating safety and effectiveness in women seeking primary breast augmentation or replacement of existing augmentation implants.
Two-year follow-up visits were completed by 472 of the 502 women enrolled at 35 private practices. Of these, 378 had undergone primary breast augmentation and 94 had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3 percent for primary augmentations and 92.3 percent for replacement augmentations. Moreover, surgeon-reported satisfaction was also high (96.5 percent and 93.4 percent, respectively). The incidence of moderate-to-severe wrinkling was 3.8 percent (primary) and 12.0 percent (replacement). Baker Grade III and IV capsular contracture rates were 3.8 percent (primary) and 8.2 percent (replacement).
These two-year rates are lower than those reported for current single-lumen saline implants at one year. Deflations, none of which were caused by a shell fold flaw, occurred in 4.8 percent of primary augmentations and 3.3 percent of replacement augmentations, the study showed.