This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Macroplastique ® Implants
PMA Applicant: Uroplasty, Inc.
Address: 2718 Summer Street NE, Minneapolis, MN 55413
Approval Date: October 30, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040050a.pdf
What is it? Macroplastique ® is a permanently implanted device used to treat women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles. The device is a toothpaste-like gel that is injected into the wall of the urethra near the bladder. After injection, Macroplastique ® bulks the wall of the urethra to help prevent uncontrolled urination.
How does it work? Women with stress urinary incontinence tend to experience uncontrolled urination during exercise or certain other body movements such as sneezing and coughing. One cause of stress urinary incontinence is a weakness of the urethral sphincter muscles that help open and close the tube from the bladder that drains urine from the body (urethra).
Macroplastique ® is intended to keep urine from accidentally leaking out of the bladder in women with poorly functioning urethral sphincter muscles by bringing the walls of the urethra closer together. Using a small tube to view the bladder (cystoscope), the physician injects Macroplastique ® into the wall of the urethra. After injection, a part of the gel is absorbed by the body in a few weeks but the solid particles remain to provide for bulking of the urethral wall.
When is it used? Macroplastique ® is used in adult women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles.
What will it accomplish? In a clinical study, 58% of women had significant improvement in their incontinence 1 year after receiving Macroplastique ® (based on which activities caused urine leakage), over half of whom were dry. In 23% of women, incontinence was either worse or unknown. In terms of the amount of urine leakage, 60% of women experienced at least a 50% reduction of leakage after treatment as compared to pretreatment leakage. Approximately half of patients required a repeat injection of Macroplastique ® to achieve satisfactory results.
When should it not be used? The device should not be used in women who
- have signs of a urinary tract infection or other urogenital infection, or
- have thin or weak urethral wall tissue.
Additional information: Summary of Safety and Effectiveness Data and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040050
- Stress incontinence patient page:
- Diagram of female lower urinary tract:
- Information on urinary incontinence: