How Many Times Will Your Breast Implants Have to be Replaced?

Sep 15, 2011 by

If you are 30 years old and live to be 80, it could be 4 or 5 times and would certainly be at least once. How do I determine that? I follow the USA FDA’s guidelines. The FDA recently published a patient booklet Titled Breast Implants Local Complications and Adverse Outcomes that stated the following:

As many as 20 percent of women who receive breast implants for breast augmentation have to have their implant removed within 8-10 years. Over the course of your life, you may need to have your implant removed due to local complications.

That is shocking news- 1 out of every 5 women that have breast implants will need to have them replaced every 8 to 10 years?

If you are going to have breast implant surgery and expect to live for 40-50 more years, your worst case scenario would be having the implants replaced 4 or 5 times. According to the FDA statistics 20% of women have them replaced every 10 years- so if you had the breast implants for 40-50 years, statistically you would have them replaced at least once. As always, I have to ask the question- who pays for the replacement?

So what causes these local complications? Again from the FDA booklet about breast implant local complications:

The most common local complications and adverse outcomes associated with breast implants — silicone gel-filled and saline-filled—are capsular contracture, reoperation, implant removal, and rupture or deflation of the implant.

So let’s talk about capsular contracture and how to reduce it. A detailed explanation about capsular contracture can be found here: http://www.furrybrazilian.com/capsular-contracture/.

There is no exact cause for capsular contracture, the event that causes the contracture has not been identified and capsular contracture can happen at any time. The rate of capsular contracture has not been shown to change according to implant size or shape.  The implant surface- smooth, textured or Polyurethane foam- has the most dramatic impact on the rate of capsular contracture. Here is a summary of data from different implant companies patient information booklets, this same information was submitted to the USA FDA:

IMPLANT MANUFACTURER SiliconeImplant Surface Type PATIENTS IN STUDY STUDY TIME FRAME CAPSULAR CONTRACTURE RATE (Baker Grade 3 & 4)
Allergan® Smooth/Textured 455 7-Year 15.5%
Mentor® Smooth/Textured 551 3-Year 8.1%

I am not sure where the FDA is coming up with 20% at 8-10 years as it does not match the capsular contracture rate of the 7 year study above. What I do now is that Polyurethane Foam silicone gel implants have a document capsular contracture rate of under 2% and as low as 1%. Guillermo Vazquez, M.D. and Andreas Pellon, M.D. conducted a study published in 2007 that involved 1,257 patients with Polyurethane foam silicone gel breast implants; the patients were followed for a long duration- 300 for 5 years (clinical controls every 3 months), with 250 patients being followed for 10 years and 180 for 15 years.

The results of their study: Using the Baker classification of capsular contracture, we found an approximate 1% incidence of fibrous capsular contraction. With regard to complication, we found rates similar to those reported in our first article: hematoma (1.2%), seroma (2%), and infection caused by Staphylococcus epidermidis (three cases). No cases of late seroma were observed with the use of these prostheses.

Polyurethane foam has a lower rate of capsular contracture over a longer time- leading to a lower overall rate of reoperation and breast implant replacement.

What else does the FDA say in their booklet?  A big discussion of implant removal with a scary picture:

One type of reoperation involves the surgical removal of your implants, which may or may not include implant replacement. As many as 20 percent of women who receive breast implants for breast augmentation have to have their implant removed within 8-10 years. Over the course of your life, you may need to have your implant removed due to local complications. Many women have their implants replaced, but some women do not. Women who do not have their implants replaced may have cosmetically undesirable dimpling, puckering, or sagging of the natural breast following implant removal.

Photograph 2 shows a 29-year-old woman one year after having her silicone gel-filled breast implants removed. This is the same woman from Photograph 1.
Implant removal without replacement in augmentation patient.
Photograph 2
Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

I encourage you to do all you can to reduce local complications and reoperation, choose a well qualified doctor, follow the recovery guidelines and certainly research and evaluate the breast implant surface type- Polyurethane foam covered silicone gel- that has the lowest rate of local complications associated with it.

 

 

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