A 16-year follow-up on a patient with silicone breast implants in a nurse who first presented in her early 30s with a desire to have fuller breasts, She described herself as a 32 A cup. She had a bilateral partial sub-pectoral breast augmentation with a 350 cc smooth round silicone gel implant on each side. Her postoperative course was uneventful and she had a child and breastfed after her surgery. She continues to do well 16 years later. She comes in today for a breast check. Her breasts remain soft, and she continues to get routine mammograms for breast health. She now wears a 32 C cup, Her breasts remain soft and have settled slightly with time, pregnancy, and breastfeeding but continue to have an excellent appearance.
Her reason for coming in is to check her breast implants. In patients with no symptoms a silicone breast implant rupture is often “silent”, ie, there are no visible or palpable signs. A saline implant is easier to follow because it will deflate when there is a leak and the breast will become visibly smaller. An implant failure with a saline implant is not “silent”
Breast implants are not meant to last your lifetime.
Like our patient shown here, 90% of breast implants used in the US for breast augmentation now are smooth, round silicone gel filler implants. Rupture rates with breast augmentation vary depending on the implant study but around 10% of silicone breast implants have failed by 10 years.
There has been a little confusion because the FDA shook things up a little bit with new recommendations that they released in 2022.
BEFORE 2022 the recommendation from the FDA in breast augmentation patients with no symptoms was to get a non-contrast MRI every 2-3 years. And a non-contrast MRI is still thought to be the gold standard for detecting breast implant rupture. But patients weren’t generally getting routine screening MRIs— it was expensive, insurance companies often didn’t cover the cost in patients with no symptoms, and many patients don’t like being in an MRI scanner.
So in 2022, the FDA changed to recommend MRI or ultrasound starting 5 -6 years after the initial surgery. Why 5-6 years? Waiting 5-6 years was recommended because the chance of having a rupture in less than that time was very low and they didn’t feel that it made sense to screen before then.
Studies have been done showing that diagnostic ultrasound is very good at screening asymptomatic patients, as well as being more widely available and lower cost.
So the current FDA recommendation in breast augmentation patients without symptoms is ultrasound or MRI starting 5-6 years after breast implant placement and then repeating this every 2-3 years to monitor for asymptomatic silent rupture. So she is going to get a screening ultrasound.
The link to the FDA’s section on breast implants is below
https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
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