Larry S. Nichter, MD; and Robert S. Hamas, MD
“Two-Year Outcomes With a Novel, Double-Lumen, Saline-Filled Breast Implant”
Originally published by the American Society for Aesthetic Plastic Surgery, Inc.
Background: A double-lumen, saline-filled breast implant with a baffle structure (IDEAL IMPLANT Saline-Filled Breast Implant; Ideal Implant Incorporated, Irving, Texas) was developed to overcome the limitations of single-lumen saline implants by controlling saline movement and providing internal support to the implant edge and upper pole.
Objective: The authors report 2-year data from a 10-year US clinical trial evaluating the safety and effectiveness of this investigational implant.
Methods: Women seeking primary breast augmentation or replacement of existing augmentation implants were enrolled between February 2009 and February 2010 at 35 private practice sites, where the women underwent surgery to receive the new technology implant. Data collection included incidence and grade of capsular contracture (CC) and wrinkling as well as patient- and surgeon-reported satisfaction measures. All clinical data were reported as Kaplan-Meier risk rates of first occurrence, per patient, in each cohort.
Results: Two-year follow-up visits were completed by 472 of 502 enrolled women (94.0%), 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). Baker Grade III and IV CC rates were 3.8% (primary) and 8.2% (replacement), whereas moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Deflations occurred in
4.8% of primary augmentations and 3.3% of replacement augmentations. No deflations were caused by a shell fold flaw.
Conclusions: Two-year data from 472 women indicate that this double-lumen saline implant containing a baffle structure has a low rate of wrinkling and a lower rate of CC at 2 years than was reported for current single-lumen saline implants at 1 year.
Although saline-filled implants are a safe, effective alternative to silicone gel-filled implants,1 the currently available saline-filled implants are essentially balloons filled with freely-moving fluid, which may result in an unnatural feel or suboptimal aesthetic result.2-5 These implants, which have only a single lumen, tend to be less forgiving than silicone gel implants in terms of palpability, visibility, and rippling.5,6 Scalloping or wrinkling, for example, is a well known problem.5-7 This may be a significant part of the reason that 31% of women in the United States chose saline-filled implants for breast augmentation in 2011.8 For a more natural result, the only currently available alternatives to saline-filled implants are silicone gel-filled implants, which some women will not accept. Clearly, there is a need for a saline-filled implant that offers a more natural result, without the wrinkling, bouncing, or globular shape commonly attributed to current saline implants.2-5 Continue reading