Saline Filled High Profile Breast Implant
The rule of thumb is that breast implants should be changed every ten years, but is this really true? Should breast implants be replaced at their tenth anniversary? If your breast implants are ten years old, is it time to change them? The question comes up every day in my Walnut Creek Breast Augmentation practice, so here are the current recommendations on the San Francisco plastic surgery blog.
Why are Breast Implants Removed?
According to the FDA, breast implants are not considered lifetime devices. In order of occurrence, the most common reasons for breast implant removal are:
1) the patient’s desire to change implant size or style, 2) deflation and 3) capsular contracture. These three reasons account for about 90% of all the breast implants that are removed. Sheyla Hershey had her implants removed due to infection, and possibly exposure. This is not a common reason for breast implant removal, and she is not the ordinary breast augmentation patient. Excess breast implant size is associated with a higher reoperation rate. Other less common reasons for implant removal and replacement include: implant malposition, wrinkling, palpability, breast pain and iatrogenic injury (inadvertently broken by a doctor). Not on the list: breast implants are ten years old.
The Older the Breast Implant the More Likely it is to Fail
If you are happy with your size, there is no indication of leakage, your breast remain soft and are not painful, the fact that your breast implants are ten years old is not a reason to have your implants removed or exchanged. The older the implant, the more likely it is to wear out, but most breast implants last longer than ten years.
For saline implants, leaks are pretty easy to determine. If saline filled breast implants leak, they flatten, and it is obvious that there is a leak. For silicone gel filled breast implants, the shell of the implant can be damaged without any outward sign of leakage. This is termed a silent rupture. If you have silicone gel filled breast implants, the FDA recommends obtaining an MRI of your breasts at three years, and then every two years after surgery to check for a silent leak. If a leak is discovered, the implant should be removed, or replaced, to prevent gel migration and additional scar formation.
Breast Implant Warranties
The two US based breast implant manufacturers offer warranties on their breast implants. Both offer similar warranties, although the details vary by manufacturer and implant (saline vs. gel).
At the time of this post, both companies will replace a defective implant for free. Both companies will allow you to change style with the cost based on the differential between the current implant and the new style selected. If the new style costs more, you are charged only the difference in price in most cases. Financial support is also available during the first ten years to reduce the cost of the replacement surgery.
Details can be found on your breast implant manufacturer’s web site. For the United States in 2010, it will be either Allergan or Mentor. Click here for the Allergan (Natrelle) Breast Implant Warranty or here for the Mentor Breast Implant Warranty. If you do not know the manufacturer, please contact your plastic surgeon. They should keep a record of your implant manufacturer, catalogue number and size.
So What Are the Odds of Needing My Implants Changed 10 Years After Surgery?
The best numbers currently available come from the post-approval studies available online from the manufactures. Reoperation rates for any reason, varied from 25% to 50% at ten years, and about half involved removal or replacement of the breast implants. This means as many as 25% of women undergoing breast augmentation had their implants removed or replaced at the ten year mark. It also means that 75% of women followed did not need their implants changed at 10 years. Unfortunately, almost half the patients originally enrolled in the studies were unavailable at ten years. It is unclear how to extrapolate to include those that are missing from the data. Are they having surgery at the same rate, or have they dropped out because they are fine and don’t have any problems?
If I Have a Problem With My Breast Implants, Can They be Replaced Immediately?
While some women do elect to have their breast implants removed and not replaced, the majority have them exchanged, usually for larger breast implants. The numbers vary from study to study. Both Allergan and Mentor have ongoing ten year saline and silicone breast implant follow-up studies to try to obtain the highest quality data with the newest implants available. Hopefully, compliance will be enhanced since study questionnaires can now be completed by patients on-line. If you are participating in one of the breast implant follow-up studies, I encourage you to complete your surveys and make your follow-up appointments to enhance the study’s accuracy.
Breast Implant Revision Surgery
The bottom line is that most breast implants do not need to be replaced at ten years. If you have breast implant surgery, it is reasonable to expect to need another surgery at some point in the future. The chances of having breast augmentation revision surgery within ten years of your initial breast augmentation is somewhere between 25% and 50%, and only about half of these breast augmentation revision surgeries involve replacing the breast implants. Reoperation rates are higher for breast reconstruction after a mastectomy. If your breast implant has deflated, be certain to check your warranty. Most deflated implants will be replaced at no cost, and you many be eligible for assistance to defray the cost of surgery if the replacement occurs within ten years of your primary breast augmentation.
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