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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.





P97-34                        FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE         Sharon Snider:     301-827-6242

September 29, 1997            

                              Consumer Inquiries: 800-532-4440



     FDA APPROVES IMPLANTED DEVICE TO CONTROL INCONTINENCE



     The Food and Drug Administration today approved an implanted

nerve stimulator to treat a serious type of urinary incontinence

in adults.

     The device is intended for women and men who have urge

incontinence, a sudden uncontrollable loss of urine caused by

involuntary bladder wall contractions.  Such contractions may

result from neurological conditions such as spinal cord injury,

stroke, spina bifida or multiple sclerosis, or from other bladder

problems.  Urge incontinence affects an estimated 5 million

adults -- mostly women.

     "Implanted nerve stimulators can significantly improve the

quality of life of people with urge incontinence because they

allow them to go out in public with confidence and without fear

of embarrassment," said FDA Lead Deputy Commissioner Michael A.

Friedman, M.D.  

     The new device, the Sacral Nerve Stimulation System made by

Medtronic, Inc., of Spring Lake Park, Minn., requires major

surgery and is intended for use when other less invasive

treatments such as drugs and diet modification have failed. About

20 percent of people with urge incontinence would be able 

to benefit from the device.

     The product consists of a pulse generator about the size of

a pacemaker which is implanted in the abdominal wall and a wire

lead which is attached to the nerves near the sacrum, the large

bone at the bottom of the spine.  The generator sends tiny

electric impulses via the implanted wire to the sacral nerves,

which help control the bladder contractions.  The basic

technology of the generator and wire lead is almost identical to

that used in another Medtronic device approved in July by FDA, a

brain implant for patients with uncontrollable tremors.

     FDA's approval of the incontinence device was based on a

review of clinical studies on safety and effectiveness conducted

by the manufacturer and on the recommendation of the

Gastroenterology and Urology Devices Panel of FDA's Medical

Devices Advisory Committee.

      To determine effectiveness, surgeons implanted the device

in 86 patients with urge incontinence at 16 medical centers in

North America and Europe.  Eighty percent of the patients were

women.  All patients were screened with a temporary nerve

stimulator implanted through the skin prior to receiving the

permanent implant.  Of those screened, 63 percent responded to 

the temporary stimulator and were considered extremely likely to 

benefit from permanent implantation of the device.  It was these

from permanent implantation of the device. 

     The device significantly reduced or eliminated urinary 

incontinence in most patients, meaning the need for absorbent

pads or diapers was reduced or eliminated.  For example, after

six months, 47 percent of patients were completely dry, and an

additional 28 percent experienced a reduction in the number of

leakage episodes by at least 50 percent.  Similar results were

seen 12 months and 18 months later.

     Safety was evaluated in 157 implanted patients who had

either urge incontinence or other voiding difficulties.  In

approximately one third of the patients, at least one additional

surgery was required because of problems with the device.  The

most common  problem (35% of patients) was long-term pain, most

frequently related to the position of the generator on the

abdominal wall.  Surgery to reposition the generator usually

resolved this problem.  Another side effect requiring surgery was

migration of the implanted lead wire (7%).  Infection or

inflammation of the skin (6%) was corrected without surgery in

most patients.

     The device is battery operated, and the battery life is 7 to

9 years.  When the battery loses power, surgery will be needed to

replace it.

     FDA is requiring Medtronic to do a five-year study of the

device after marketing to determine its long term safety and

effectiveness.

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