San Francisco, CA-Manufacturers of breast implants all state that implants are not lifetime devices, however, most companies including Mentor give free replacement of qualifying devices that have failed, for the lifetime of the patient. Most companies offer additional monetary compensation to help defer the cost of breast revision surgery for up to ten years.
Statistics show that the percentage for failure of an implant is approximately 1% per year. At 10% probable failure rate at 10 years, the manufacturers no longer offer to help with cost of surgery for replacement. This statistic has caused confusion for many (see the previous blog dated July 15, 2013). This does not mean that implants must be replaced at the 10 year point. Some women will have issues with their implants much earlier and some much later and for a lucky few maybe never. You should assume that you will need a revision at least once in your life and very possibly within the first ten years. If you are not having any issues with your implants, you do not need to have them replaced, but you should keep current with your breast exams with your doctor. See breast implant pictures before and after revision of some of Dr. Delgado’s patients here.
It is interesting to note that many people use the terms rupture and deflation interchangeably. Some say rupture refers only to silicone implants, and deflation refers only to saline implants. The FDA states that the term rupture can refer to any type of breast implant, but deflation will only be used to describe saline breast implants.
Saline implants are filled after insertion during surgery by a valve that can fail at some point or leak. Silicone gel implants are pre- filled by the manufacturer, requiring a somewhat larger incision for insertion, but they have less probability of rupture.
Saline breast implants can deflate very quickly or slowly over a period of a few days. The deflation will be very evident to the patient as the breast will have lost volume looking like a flat tire or a deflated balloon. The saline that leaks into the body is harmless and will come out in your urine. It is not a medical emergency requiring replacement surgery immediately, but the sooner the better as the pocket will start to shrink, and scar tissue may set in making revision surgery more difficult.
Silicone gel implants prior to 1992 were filled with a gel that was more of the consistency of thick honey. If an implant were to rupture, the gooey gel could migrate to other parts of the body, making the removal of the implants a challenging and tedious procedure for breast revision specialists. Suspicious health problems were surfacing, and the FDA placed a moratorium on silicone implants until major improvements and studies were conducted. After many years of trials, in 2006 the FDA approved the new silicone implants that are made of a more cohesive gel.
With the approval of the new gel implants came a warning from the FDA. Besides only being available to women 22 years of age and older, the FDA recommends that women have a magnetic resonance imaging (MRI) of their breasts after 3 years of their original surgery, and then every 2 years after that, to monitor for “silent leaks”. Due to the costs involved for this test, which can range from $1,000 to $2,000 depending on what part of the country you are in, many women choose have a MRI only if they have issues. Keep in mind that a MRI is not a perfect science; false positives have been known to occur. Any concerns that you may have with your breasts should be brought to the attention of your plastic surgeon who will help you determine the best course of action.
Some causes for deflation of breast implants are:
• Capsular contracture, (the constricting formation of scar tissue around the implant)
• Mammogram, (be sure to inform your technician that you have implants)
• Implant age
• Overfilling/under filling of saline implants(beyond what the manufacturer recommends)
• Breast trauma (car accident, closed Capsulotomy)
• Non-FDA approved incision site (the belly button)
• Surgical instruments during surgery
• Defective valve of the saline implant
Even with the possibilities of future breast revision surgeries, breast augmentation for women in the United States was the most sought after of all cosmetic procedures in 2012, according to the American Society of Aesthetic Plastic Surgeons (ASAPS). ASAPS reported that there were over 330,000 breast augmentation procedures performed with 72% of women choosing silicone implants over saline.