Last week, the U.S. Food and Drug Administration (FDA) authorized approval of the first permanent implant to relieve low or blocked urine flow. This implant is approved for men with an enlarged prostate who are older than 50 years of age, and is manufactured by California-based Neo Tract Inc.
Director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiology Health, Christy Foreman, said, “The UroLift [implant] provides a less invasive alternative to treating BPH (benign prostatic hyperplasia) than surgery. This device also may offer relief to men who cannot tolerate average drug therapies.”
BPH is the medical term used to describe an enlarged prostate, which is a walnut-sized gland under the bladder in men. When the prostate becomes enlarged, urine may be restricted, or even blocked, which could cause extreme discomfort. This UroLift system relieves the urine flow by pulling the prostate tissue back, to divert pressure away from the urethra.
In the FDA’s review of the UroLift system, they analyzed date from two clinical studies. Both of these studies showed a 98 percent success rate in doctors’ insertion into the patients in the studies. Additionally, the study showed a 30 percent increase in urine flow, as well as a steady amount of residual urine in the bladder.
The patients involved in this study completed a questionnaire, and in this questionnaire, they revealed that they had a decrease in symptoms, as well as an increase in the quality of life two years after the surgery.
It is worth noting, however, that there were some adverse side effects reported in this study, which included pain or burning during urination, blood in the urine, frequent or urgent need to urinate, incomplete emptying of the bladder, as well as decreased urine flow. There were no serious device-related adverse occurrences.
More than half of all men in their sixties, and almost ninety percent of men in their seventies and eighties have some symptoms of BPH. Severe cases of BPH can lead to serious problems such as straining the bladder, urinary tract infections, bladder or kidney damage, bladder stones, and the inability to control urine, also known as incontinence.
The approval of the UroLift by the FDA brings good news in the medical world, as there are currently few options when treating BPH, such as drug therapy, or surgical procedures, including removing the enlarged part of the prostate.
For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).