By World News Report Bureau
Over 150,000 women who opted for silicone gel implant do not realize it but may be victims of “silent rupture” causing sticky silicone gel to come in contact with their tissues. Rupture of the silicone gel implant implant— occurs when there is a tear or hole in the silicone gel implant’s outer shell.
Breast implants are not lifetime devices. As many as 20 percent women who receive implants for breast augmentation have to get them removed within 8-10 years due to one or the other local complication. The longer a woman has implants, the more likely it is that she might need to remove or replace them. Many women have their implants removed or replaced, but those who don’t end up living with undesirable disfigured, wrinkling or flaccid breast following the implant removal.
Some breast implants rupture may be observed in the first few months of the surgery while some others may rupture after 10 or more years. A few possible causes of rupture include: compression during a mammogram; damage due to surgical instruments or procedures like biopsies or fluid drainage; normal aging of the implant; trauma or too much handling during surgery.
This is as per the findings of a survey of silicone gel implant rupture rates monitored by the US FDA, American Society of Plastic Surgeons (ASPS) and American Society for Aesthetic Plastic Surgery (ASAPS).
A rupture in the silicone gel implant, may lead to silicone gel leakage and it’s drifting away from the breast – causing the formation of lumps in the breast, chest wall, armpit, arm and abdomen.
Some women may notice decreased breast size, uneven appearance of the breasts, hard knots, pain; tenderness; tingling; swelling; numbness; burning or other changes in sensation due to ruptures in the silicone gel-filled breast implant. In a few cases – no such symptoms may be observed despite a ruptured silicone gel implant. These are known as “silent ruptures.”
Magnetic Resonance Imaging (MRI) is the most effective way to detect silent rupture of a silicone gel-filled breast implant. The FDA recommends a MRI screening three years after a new implant and after every two years thereafter for early detection of a ruptured silicone gel implant. The FDA recommends use of specifically designed MRI equipment for imaging the breast of patients with suspected rupture or leakage of silicone gel implants.
The FDA recommends immediate removal of both saline and silicone gel implants as soon as the rupture is confirmed.
“Replacing ruptured silicone gel implant 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. Its 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 silicone gel implant 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 — in silicone gel implant 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.
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.
“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.”