Methods for Prevention and/or Treatment of Capsular Contracture
J&E Solutions holds a US patent for the prevention and/or treatment of capsular contracture utilizing a repositioned topical ointment. The patent also encompasses the use of the product on fibrotic tissue with other etiologies as its formative basis. The topical composition is comprised of a pharmaceutically acceptable keratolytic, a pharmaceutically acceptable protein denaturant, a hydrating agent, and combinations thereof which are disclosed.
Our firm, founded by a registered nurse and plastic surgeon, developed and tested the aforementioned product for the prevention and treatment of capsular contracture. As established, capsules form as a normal response around a foreign body (e.g. breast implants, pacemakers, and orthopedic prosthetics) following surgery. Capsular contracture is an abnormal response of the immune system to foreign material. In such, an excessive and continued overgrowth of fibrotic tissue results in a painful, tightening and ultimately distortion of the implant necessitating medical intervention.
To date, there has been no simple, safe, and effective prevention or treatment for capsular contracture. Many methods of non-surgical management have been tried with very limited success. The more successful surgical alternatives have been a return to the OR for capsulectomy (removal) or capsulotomy (release) of the fibrotic tissue and replacement of the implants. Unfortunately, even after these procedures, 50-60% recurrence rates remain.
As per 2012 ASPS stats 5% of American women now have breast implants. With well over 400,000 breast augmentations and reconstructions performed annually in the U.S., approximately 50,000 new cases of capsular contracture are diagnosed each year. Additionally, capsular contracture rates occur in 15-30% of all breast surgeries; rates are highest in those who have reconstructive surgery. As well, hundreds of thousands continue to suffer from its effects from prior implant insertion often seeking repeated surgeries without success. We have very strong supporting clinical data for our topical’s use in its capsular contracture indication.
We hold a U.S. patent for the prevention and/or treatment of capsular contracture. J&E has strong supporting clinical data for our method and indication with a success rate well over 95%. Our product is inexpensive to manufacture, and the active ingredients and excipients are FDA approved. Thus, we believe the product can be brought to market quite rapidly.
US 84,096,002 issued 2013-04-02 [MORE INFO
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Sale or Licensing
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