Tuesday, June 24, 2003

By Valerie Reitman, Los Angeles Times

With two small children and no desire for any more, Jim Segermark's wife sat him down for that conversation. It was time he took some responsibility for birth control.

After years of taking the pill, his wife had been told by her doctor it wasn't wise to continue. "Tell the old man to get it snipped," the gynecologist had advised wryly.

Segermark, then 33, dutifully marched off to the urologist for a vasectomy. But he chickened out, he explains, after learning that the operation involved severing the vas deferens -- the sperm ducts in the scrotum -- and cauterizing them, the equivalent of taking a match to the ends of plastic straws to seal them.

Segermark was outraged that the procedure was so primitive. As an executive with a company making sophisticated wires and catheters that thread through the brain to treat aneurysms, he'd expected there'd be an easier way to close off the vas deferens to avert "burning me there."

So Segermark devised an alternative: a plastic clamp the size of a grain of rice. Shaped like a miniature barrette, it snaps onto each of the two vas deferens tubes to block permanently the flow of sperm, eliminating the need for cutting and cauterizing. Two years ago, Segermark himself became the first human to try the device.

Segermark's device, dubbed the Vasclip, which recently went on the market, may offer the most significant advancement in vasectomies since World War II, when the procedure was popularized by servicemen returning home in the era before the pill.

The company that Segermark set up to develop and market the device, VMBC, in Roseville, Minn., says its yearlong clinical study showed the procedure to be less painful and to result in fewer complications than traditional vasectomies. The Vasclip was approved by the Food and Drug Administration last August, but VMBC wanted to complete the study before launching it.

More than 500,000 men in the United States and 4 million worldwide annually undergo vasectomies, making it the third-most common form of birth control. Blocking the vas deferens cuts off the sperm flow from the testes, where it is produced. The sperm would otherwise mix with seminal fluid produced in the prostate gland and be ejaculated, possibly causing a pregnancy.

One potentially significant advantage of the Vasclip method: It may be easier to reverse than traditional methods because the sperm ducts haven't been cut and cauterized.

More info   The Vasclip procedure is not yet available at UPMC Health System or Allegheny General Hospital, according to hospital spokeswomen. One local doctor trained in the procedure, Uniontown urologist Subodh Patel, said insurance issues still need to be worked out. So far, the cost is not covered. Still, he described the procedure that can be done in his office as "technically very, very simple." The key is applying the clip accurately. Recovery is much shorter than that of a vasectomy. You can find more information at www.vasclip.com

About 5 percent of men who undergo a traditional vasectomy later change their minds. Although reversals are sometimes successful, reattaching the vas deferens is a difficult and expensive microsurgical procedure. Dr. Phillip Werthman, of Los Angeles, who specializes in reversals, nevertheless advises patients contemplating vasectomies, "If you're thinking of a reversal [in the future], don't think of having a vasectomy."

As for the possibility that the Vasclip will increase the chances of reversal because it can be more easily removed and won't have to be reattached, Werthman says, "It won't be harder and it may be easier."

Further studies by the company are under way to determine whether sperm flow can be restored fully after the Vasclip is removed. Initial testing on animals is promising, Segermark said, with no atrophy or necrosis of the vas deferens after the Vasclip was removed.

Most health insurers now pay for the urologist's surgical fees, which typically run $300 to $1,200 for a vasectomy, and VMBC expects the insurers will also pick up the $385 cost of the Vasclip it sells to the doctors.

One drawback: Vasclip's initial study found that doctors applied the clip incorrectly on three of 119 men, allowing some sperm to get through. Vasclip says it has improved its training procedures to avert future problems.

Most men submit to vasectomies with great trepidation. But Vasclip's promise of less pain and fewer complications may encourage more men to undergo the 10-minute procedure, which is performed in a doctor's office.

That would be good news for women, who would surely welcome an alternative to the far more complicated and expensive tubal ligation procedure, in which their Fallopian tubes are closed off so eggs can't be fertilized by sperm. Female sterilization typically requires a hospital stay of one to four days and general anesthesia.

Nevertheless, tubal ligations are more often performed than vasectomies. Earlier this year, a less invasive, nonsurgical sterilization technique for women called Essure came on the market that can be done in a doctor's office.

Other than a vasectomy, condoms and abstinence, there is no reliable birth-control alternative for men. The male birth-control pill and other techniques, including implantation of sperm-killing agents and ultrasound of the testicles to immobilize sperm -- have been tried but with no luck so far.

More than 225 physicians have been trained to apply the Vasclip since it was introduced April 27 at the American Urology Association's annual meeting.

VMBC says complication rates and pain were significantly lower with the Vasclip than with traditional vasectomy techniques.

About 76 percent of the men in Vasclip's clinical trial indicated there was "no pain at all" or "less than expected," and 99 percent said they were satisfied with the procedure and would recommend it to their friends.