Medication Monitor

Generic Name (Trade Name—Company)
May 27, 2011

Dextranomer microspheres and stabilized sodium hyaluronate

(Solesta—Oceana Therapeutics)
Injectable gel device for treatment of fecal incontinence


Treatment of fecal incontinence in adult patients who have failed previous therapies such as modifications in diet, fiber therapy, or antimotility medications 

Solesta 1 mL injectable gel consists of dextranomer microspheres (50 mg/mL) and stabilized sodium hyaluronate (15 mg/mL) in a phosphate-buffered 0.9% sodium chloride solution. It is injected into the deep submucosal layer in the proximal part of the high pressure zone of the anal canal. A total of four submucosal injections are administered at each treatment session. The injections are designed to build up tissue in that area so that the opening of the anus narrows allowing patients to have better control of their muscles. Only physicians experienced in performing anorectal procedures and who have successfully completed the Solesta injection procedure training program can administer the gel.