In November 2014, the FDA approved Ideal Implants, which are saline filled, for primary breast augmentation and revision breast augmentation. These implants will be available to board-certified and board-eligible plastic surgeons in mid-September 2015.
The Ideal Implant is different than other FDA-approved saline-filled breast implants in that it has two lumens within two shells that are attached at the patch on the back of the implant, according to company literature.
The implant’s inventor, plastic surgeon Robert Hamas, M.D., who is CEO and president of Dallas, Texas-based IDEAL Implants, tells Cosmetic Surgery Times that the Ideal Implant Structured Breast Implant combines desirable features of silicone gel and saline-filled implants, while eliminating undesirable features of each.
“It offers a natural feel without silicone gel, and the safety of only saline inside for peace of mind. Since silicone gel implants have a high rate of silent rupture, a women cannot tell if her implants are intact or ruptured without an MRI scan; while, with the Ideal Implant, a woman can simply look in the mirror and be confident that her implants are intact,” Dr. Hamas says.
The issue of silent rupture is a big issue and a strike against silicone gel, according to Dr. Hamas.
“FDA approved silicone gel implants as ‘safe,’ but also recommended MRI scans every two years to detect silent rupture. Many surgeons discount this recommendation, because they are under the mistaken impression silicone gel implants have a low rate of silent rupture. In fact, in the FDA clinical trials, the cumulative incidence of rupture of silicone gel implants was 10% to 24% in the MRI cohort of women having primary augmentation (Allergen and Mentor),” he says. “The type and incidence of adverse events seen in the clinical trial of the Ideal Implant were similar to those reported in other breast implant trials. Both patient and surgeon satisfaction were high, and the incidence of capsule contracture was low.”
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Clinical Trial Data
According to clinical trial data available on the FDA’s website, of 502 women who received Ideal Implants, complication rates through two years were 42.2% for primary augmentation and 50.5% for revision augmentation patients (p.37). Grade II/III/IV capsular contracture occurred in 17.1% of primary augmentation patients and 24.3% of revision augmentation patients (p.24). And “spontaneous deflation” occurred in 5% of primary augmentation and 3% of revision augmentation patients (p.24). Complication and spontaneous deflation rates were based on data from 456 patients in the study. Forty-six patients received an early design of the implant, which is no longer being manufactured.
“Some clinical trial implants made in 2009 at the trial manufacturing site in Montana deflated due to an assembly defect. This was corrected with improved process controls and inspections, along with moving manufacturing in 2010 to a California company with a comprehensive quality control system and more than 30 years of experience manufacturing silicone medical devices,” Dr. Hamas says.
Boca Raton, Fla., plastic surgeon Cristina Keusch, M.D., tells Cosmetic Surgery Times that saline rupture rates are generally always higher than silicone gel.
“This is the case with Ideal as well, with significantly higher rupture rates at two years compared to, Natrelle, Sientra and Mentor. Also, the overall complication rate is high at two years, [at] 42%. I would like to see how these implants fair in longer term studies, ie. five and 10 years,” Dr. Keusch says.
Overall satisfaction with the implants was good among physicians. More than 83% indicated they were “definitely satisfied” with outcome after primary augmentation and 77.9% after revision augmentation. More than 78% of primary augmentation and more than 76% of revision augmentation patients and said they were “definitely satisfied” with outcomes.
The 'Ideal' Approach
According to Dr. Hamas, the operative procedure for insertion of the Ideal Implant is the same as for the original saline implant, except there are two fill tubes for the two lumen, and overfilling is not needed.
“In the clinical trial, it was used in the sub-glandular and sub-muscular planes, and inserted through inframammary, peri-areolar and axillary incisions,” he says.
Whether the new saline implants will impact surgeon and patient preferences is yet to be seen.
Dr. Keusch says she uses both saline and silicone gel implants, but more than 95% of her patients select silicone gel.
“I feel that silicone is the superior fill product, both in terms of its consistency and feel, but also in term of its safety and track record,” she says. “I am always open to new products, but would need to have a compelling reason to select a double lumen saline implant. The price point will also be a consideration for my patients.”
Dr. Keusch says the most important feature of the Ideal Implant is that it gives women another option in implant choice.
“If, in fact, the design of the Ideal Implant provides a more natural feel than a traditional single-lumen saline implant, then women may consider this option over silicone implants,” she says. “In my practice, the only reasons patients choose saline over silicone implants are concern over ease of diagnosis of rupture, but unfortunately the higher rupture rates may negate this advantage.”
For more on Ideal Implants, go to: http://www.idealimplant.com.
Dr. Hamas is the CEO and President of Ideal Implants.
Dr. Keusch reports no relevant disclosures.