Since FDA Approval, Cumulative Data shows Over 150,000 Women with Silicone Gel Breast Implants Unaware They Are Living with “Silent Rupture," According to ASPS & ASAPS

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Patient and Surgeon Concerns Increasing Demand for New Technology

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Thousands of US women with FDA-approved silicone gel implants do not realize their implants have ruptured, according to cross-referenced data from The American Society of Plastic Surgeons (ASPS), The American Society for Aesthetic Plastic Surgery (ASAPS) and silicone gel implant rupture rates monitored by the FDA. As an MRI is recommended by FDA after the first three years then every two years to detect silicone gel implant rupture, conservative estimates point to over 150,000 women across the country living daily with “silent rupture”— and sticky silicone gel in contact with their tissues.

“Replacing ruptured silicone gel implants has been a very common surgery for plastic surgeons, due to the rates of rupture and capsule contracture,” explains Newport Beach Plastic Surgeon Larry Nichter, “This is driving demand for new technology advancements like the structured IDEAL IMPLANT. It’s internal baffling structure provides a similar natural look and feel to silicone gel implants, it has a very low rupture risk, easy rupture detection by looking at the breast, and only saline coming into contact with body tissue if the implant shell is compromised. So it’s clear why more women are choosing this third option.”

ASPS reports that 4.93% of the 158.3 million women in the United States have undergone breast augmentation surgery. As the top cosmetic surgery procedure in the US for over a decade, procedures are up 40% since 2000, with over half of patients choosing silicone gel or “gummy bear” implants since the FDA allowed them back on the market in 2006. With rupture risk ranging from 8.7% to 24.2% over ten years, and no way to easily detect rupture without a potentially costly MRI, tens of thousands of women with ruptured silicone gel implants are unaware of what is happening inside their body. (https://www.plasticsurgery.org/news/plastic-surgery-statistics)

Even if many women are in the dark about whether their silicone gel implants are intact, this doesn’t mean they aren’t worried. According to survey results of 1,143 women presented at the March 2018 ASPS meeting, 97% said they would want to know if their silicone gel implants were ruptured, with 95% wanting the faulty implant replaced, even if it was not causing symptoms. Anxiety about potential rupture also ran high, with most women reporting they would be “very” or “constantly” concerned of silicone gel silent rupture (73%), including 68% of women who already had silicone gel implants. (https://www.surgery.org/media/news-releases/statistics-surveys-and-trends)

“After years of struggling with ruptured silicone gel implants in my practice and hearing countless patient concerns, I felt women shouldn’t have to choose between the natural look and feel of a silicone gel implant and the peace of mind of saline in their body,” explains Robert S. Hamas, MD, President and CEO of Ideal Implant, the maker of the IDEAL IMPLANT® Structured Breast Implant approved by both FDA and Health Canada in 2014. “We all expect technology advancements in every aspect of our lives, and it was time to develop a third option that provided the benefits of both of the earlier implant choices without the drawbacks—truly an ideal solution.”

For more information please visit https://idealimplant.com/.

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Pamela Wadler
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