VASCLIP

Description of Event or Problem

I HAD A VASECTOMY PERFORMED IN 2005. THIS VASECTOMY WAS PERFORMED USING A DEVICE KNOWN AS VASCLIP WHICH IS MANUFACTURED, MARKETED AND DISTRIBUTED BY VMBC LLC OF 3564 ROLLINGVIEW DRIVE, SUITE H, WHITE BEAR LAKE, MINNESOTA, 55110. TELEPHONE NUMBERS TEL: 651.631.1830 FAX; 651.631.1850 AND WEBSITE WWW.VASCLIP.COM. I RESEARCHED THIS DEVICE FOR APPROX SIX MONTHS BEFORE DECIDING TO HAVE THE PROCEDURE PEFORMED WITH THIS DEVICE. ITS PROPORTED ADVANTAGE TO A TRADITIONAL VASECTOMY WERE 100% EFFECTIVENESS WITH REDUCTED PAIN AND INFLAMMATION DUE TO LESS ACTUAL TISSUE CUTTING THAN A TRADITIONAL VASECTOMY. I PERFORMED THE REQUIRED TESTING POST PROCEDURE PER FACILITY'S PROTOCOLS AND WAS DECLARED STERILE 5 MONTHS LATER. IN 2007, MY WIFE INFORMED ME SHE WAS PREGNANT. THIS CAUSED EXTREME STRESS IN OUR RELATIONSHIP AS WE WERE INFORMED THAT THIS COULD NOT BE POSSIBLE IF I WAS THE PARTNER. I HAD A SEMEN ANALYSIS PERFORMED IN 2007 AND IT WAS POSITIVE FOR SPERM. I WAS IMMEDIATELY EXAMINED THOROUGHLY BY DR AND HE CONFIRMED THE CLIPS WERE IN PLACE AS HE HAD PLACED THEM AND THAT I WAS INDEED PASSING SPERM IN MY SEMEN. HE COULD NOT EXPLAIN THIS AND WAS ACCORDINGLY ASTONISHED THAT THE DEVICE HAD INDEED FAILED. I WAS TOLD MY OPTIONS WERE TO HAVE A TRADITIONAL VASECTOMY -AT NO COST TO MYSELF- AND THAT HE WAS VERY SORRY ABOUT THE PREGNANCY. I RAISED TWO CONCERNS: #1 DID HAVING A SECOND VASECTOMY EXPOSE ME TO GREATER RISK FOR COMPLICATIONS, WHICH HE INDICATED IT SHOULD NOT. #2 I RAISED CONCERNS THAT ALL OTHER VASCLIP PTS SHOULD BE NOTIFIED OF POSSIBLE PRODUCT FAILURE AS THIS HAS BEEN A CATASTROPHIC EVENT IN MY WIFE'S AND MY LIFE. DR SAID THAT HE WOULD RESEARCH ON SOME TYPE OF REPORTING MECHANISM FOR THIS EVENT.