Capsular Contracture & Complication Rate Following Breast Reconstruction with Augmentation

Aug 11, 2011 by

Breast implants help breast reconstruction patients attain a natural looking breast following the reconstruction.

Note- the following will review the findings of one implant manufacturer, I am not attacking the quality of their implants, merely reviewing the findings of the study they submitted to the USA FDA and that lead to the approval of silicone gel breast implants in the USA. My intent is not to portray these implants as poor quality, but to point out the FDA approved implants do not solve the issue of capsular contracture following a breast reconstruction.

I do not name this implant manufacturer, a link to their report is listed below. Note- I do not work for any implant manufacturing company or receive any compensation from any breast implant manufacturing company.

I suggest you click on the link and read the entire report, much of what I review can be found on pages 25-32.

First let’s define Breast Reconstruction- breast reconstruction is a surgery to reconstruct the breast, usually breast reconstruction is performed after a mastectomy, a trauma to the breast could also be a reason to undergo a breast reconstruction.

The reconstruction of the breast is a surgery that involves using a breast implant or tissue to create a new breast; the tissue might come from the stomach area or even the back or buttocks. It seems more common to use breast implants at this time, but the discussion about the method is one between the patient and doctor.

The goal of breast reconstruction is a natural looking breast.

The furry brazilian thinks the other goal should be long term satisfaction with the breast implants, including avoiding re-operation as the reconstructed breast has already been subject to multiple surgeries. With this in mind, we now evaluate the long term complications associated with breast implants used for breast reconstruction; the data is drawn from the FDA website and one implant manufacturer’s study.

Regarding primary breast reconstruction (with primary defined as the first time breast implants had been used), 251 patients were enrolled in the study with results submitted at 3 years, the findings:

Key Complications following primary breast reconstruction operation:

  • 27%: Reoperation
  • 8.3%: Capsular Contracture Grade III/IV
  • 7.4%: Implant Removal with Replacement with Study Device
  • 5.7%: Implant Removal without Replacement
  • 5.7%: Infection

27% re-operation is very bad news- this means 67 people of the 251 had a re-operation and that 20.83 people had a Baker Grade III/IV capsular contracture.

Unfortunately the re-operation rate continues to increase when the revision breast reconstruction patients are studied. What this means- a revision reconstruction is when the original reconstruction is being revised.

Key Complications for breast revision reconstruction :

  • 29.1%: Re-operation
  • 16.3%: Capsular Contracture Grade III/IV
  • 8.8%: Implant Removal with Replacement with Study Device
  • 5.2%: Implant Removal without Replacement

This means 17 people of the 59 had a re-operation and that 9.61 people had a The Baker Grade III/IV capsular contracture after only 3 years.This is very bad news as you see the capsular contracture rate has more than doubled from the primary reconstruction (8.3%).

Is this now a never ending loop? The rate of capsular contracture might continue to increase with each re-operation? Ugh, this is such bad news. And why I bring this up- Polyurethane breast implants have a lower rate of capsular contracture that has been documented in many (over 100?) studies. If a person has a breast reconstruction operation and then must have a re-operation and their chance of additional capsular contracture continues to increase, why is the USA FDA not doing an evaluation study with Polyurethane implants? They are approved for use in England, Australia and other countries that have a simliar usage and profile to the USA. The FDA ruled Polyurethane implants didn’t cause cancer. Why not ask for volunteers in this kind of high risk of re-operation profile to have them implanted and see the results?

Here is a link to a patient brochure from one implant manufacturer:

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM245624.pdf

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