[549155]
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.
Patient Sequence No: 1, Text Type: D, B5