Capsules of tightly-woven collagen fibers normally form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast or limit the range of motion of an artificial joint. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone breast implant rupture or leakage, and hematoma. Capsular contracture may happen again after additional surgery.
Methods which have reduced capsular contracture include submuscular breast implant placement, using textured or polyurethane-coated implants, limiting handling of the implants and skin contact prior to insertion and irrigation with triple-antibiotic solutions.
Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include massage, external ultrasound, treatment with leukotriene pathway inhibitors (Accolate, Singulair), and pulsed electromagnetic field therapy.
Mentor, one of the two FDA-approved breast implant manufacturers, performed a study which documented patient's complications with the product. In an FDA meeting presentation in March of 2000, they found that 43% of saline implant patients reported a complication within three years. Ten percent of those complaints were of severe capsular contracture.
There are four grades of breast capsular contracture - Baker grades I through IV. The Baker grading is as follows:
"Devices, Compositions and Methods Utilizing Ep4 and Ep2 Receptor Agonists for Preventing, Reducing or Treating Capsular Contracture" in Patent Application Approval Process
Oct 31, 2012; By a News Reporter-Staff News Editor at Biotech Week -- A patent application by the inventors Jiang, Guang-Liang (Irvine, CA);...