Ideal Implant has released its 10-year FDA Core Clinical Trial Data, indicating that its structured saline implant has a lower risk of two major breast implant complications compared to silicone gel implants.
The cumulative risk of rupture or deflation for the implants over 10 years after primary breast augmentation was 3.7%. The rates of capsular contracture over 10 years after primary augmentation were only 6.6%.
The company notes that when a saline implant ruptures, a wearer can easily detect partial deflation simply by looking in the mirror; whereas, with silicone gel implant ruptures an MRI or ultrasound scan is necessary to detect it.
"This data emphasizes a clear advance in breast implant technology where the old question to patients of ‘do you want saline or silicone gel?’ has become a false choice, since the original, unstructured saline implant does not offer natural results,” said Larry Nichter, MD, a board-certified plastic surgeon in Southern California and FDA investigator for the Ideal Implant. “We moved toward silicone gel implants after 2006 because they offered a better cosmetic result over the original, unstructured saline implants. Now we have the Structured Implant technology that offers the similar natural look and feel as silicone gel and doesn’t require MRI or ultrasound scans to detect rupture."
“No woman wants to deal with breast implant complications, and this very low rate of capsular contracture directly translates to a lower risk of surgical revisions—and the expense and time associated with that,” added Elizabeth Kerner, MD, a board-certified plastic surgeon in the Dallas Fort Worth Metroplex. “A year after surgery, I have to check a patient’s chart to see whether they had silicone gel or the Ideal Implant, and in my experience, the look and feel is practically identical. While different implants are appropriate for different body types, Ideal Implant has now demonstrated a superior safety profile while offering the same look and feel as gel."”