Something new for men: the clip
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 just 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 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 U.S. 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. About 5% 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 underway 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 that 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. Four out of every 100,000 women die from complications, according to Planned Parenthood. And 1% of women become pregnant each year after sterilization, with one third of those pregnancies developing in the Fallopian tubes and requiring emergency surgery.
Nevertheless, tubal ligations are more often performed than vasectomies. In a study based on 1995 data, 26% of women who’ve ever been married reported having a tubal ligation -- more than double the comparable rate in men (12%), according to the National Center for Health Statistics. That makes female sterilization the second most common form of birth control for married couples in the U.S. after the pill. Many women discontinue the pill because of side effects, such as weight gain and breast tenderness.
Indeed, it is women who typically wind up bearing the responsibility for birth control in the household, even when it comes to suggesting a vasectomy to their partners. “Men are babies,” Segermark says. “Men don’t wake up one morning and say it’s time for a vasectomy.... [The Vasclip] gives her the ability to say [to her husband] it’s not painful.”
VMBC is marketing information to gynecologists as well as urologists, and plans to place ads in women’s magazines.
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.
Doctors have shown interest in the Vasclip. More than 225 physicians have been trained to apply the Vasclip since it was introduced April 27 at the American Urology Assn.’s annual meeting. The training is simple, consisting of a manual that can be read in 15 minutes and practice applying the Vasclip on a silicone tube.
Dr. Don A. Udall, a Newport Beach urologist, says he’s impressed with the device. “It offers the advantages of less trauma, less chance of infection, less chance for bleeding and less chance for pain.”
“I’m very willing to try it and get experience with it, because I think there’s a potential benefit if it gets more men to have a vasectomy that are just scared of having a vasectomy,” urologist Werthman says.
In a more traditional vasectomy, a doctor injects a local anesthetic into the skin of the scrotum to numb it. The doctor then makes a cut in the scrotum and lifts out the vas deferens -- the tubes that carry the sperm. Each of the two spaghetti-like tubes are then cut and a small section removed. Many doctors use a so-called “no-scalpel” method, developed by a Chinese surgeon in the 1970s, that involves piercing the skin of the scrotum with a sharp forceps-like instrument, and the hole is stretched so the doctor can reach the tubes.
The basic techniques of reaching the vas deferens remain the same with the Vasclip but instead of cutting and cauterizing the tubes and then cutting out a piece of them, the doctor simply applies the Vasclip onto the vas deferens with a small device that resembles a staple remover.
With the traditional procedure, the post-surgical pain varies widely among men and can depend on the surgeon’s skill and the method used. But the third-degree burns caused by the cauterization make the vas deferens more prone to infections, especially since there is little blood supply to the muscular sperm ducts, slowing healing.
It’s standard medical practice to test twice for sperm in the semen 90 days after the vasectomy and use other birth control until then. For some men, it can take weeks or months to clear out residual sperm.
VMBC says complication rates and pain were significantly lower with the Vasclip than traditional vasectomy techniques. About 76% of the men in Vasclip’s clinical trial indicated there was “no pain at all” or “less than expected,” and 99% said they were satisfied with the procedure and would recommend it to their friends. About 5% said there was significant pain with the Vasclip procedure compared to up to 54% who reported significant pain with the traditional procedures in data of past studies analyzed by VMBC.
Segermark said the only pain he suffered during his procedure was from the needle stick from the anesthesia. The device is so tiny, he added, that he can’t feel it at all. He boasts that he went right back to work after the midday procedure, went home at dinnertime and put ice on the wound for about 90 minutes and attended a Little League game that evening. He was able to resume sex with his wife two days later.
If the Vasclip is eventually proved to be reversible, it will likely encourage other men to go ahead with the procedure, knowing that they’re covered if they change their minds. “I’m 40 and happily married with two kids,” says Segermark. “But I don’t know what’s going to happen in my life.”
