The following information is taken from the National Post, June 28th 2001.

Ottawa approves first human trials for reversible male contraceptive

Alternative to vasectomy
By Tom Arnold

Dr. Neil Pollock displays the Intra Vas Device (the white device at the end of the applicator), a reversible male implant for contraception.

Health Canada has given approval for the first human clinical trials of a reversible male contraceptive implant, a device believed to be as effective as vasectomies for men or birth control pills for women.

The trials, which begin today in Vancouver, could one day signal a significant shift in the choice of contraceptives used in Canada.

“If the trials are successful, men in between children who want to have a form of birth control for a couple of years can have the procedure and then have it removed to have a child, then maybe go back to having it implanted,” said Dr. Neil Pollock, a Vancouver physician who will lead the initial trials of the Intra Vas Device.

“There is no reason why it can’t be put in and removed a number of times.”

Dr. Pollock, who runs five clinics and is a prominent expert on vasectomies, said if the trials are successful, “I think this will be highly significant because it offers a minimally invasive, safe and reversible contraceptive option for couples. I think it could have a very significant impact in changing the contraceptive supermarket that currently exists today.”

As many as 10% of men who undergo vasectomies later seek to reverse the procedure, often unsuccessfully, he noted.

After intensive study, Dr. Pollock’s method was approved by the Health Products and Food Branch last month. An initial roster of 50 men already undergoing vasectomies from British Columbia and Quebec will take part in the trails — where they will have the device inserted, assessed and removed. They will then undergo a vasectomy.

“It is a safety study, not a study to test effectiveness,” Roslyn Tremblay, a spokeswoman for Health Canada, said yesterday.

If the initial trials are successful, health officials expect Dr. Pollock to request approval to implant the device for a longer term and then monitor its success once it is removed, she said.

“I think people will be jumping at it because it is an easier surgery and that the reversible aspect with lifestyle changes nowadays would benefit everybody,” said Kelly Meredith, a 32-year-old father of two who lives in Maple Ridge, B.C., who will be the first patient to undergo the procedure.

The Intra Vas Device is comprised of two tiny, flexible and hollow silicon plugs, each about one millimetre in diameter. During the procedure they are stretched and inserted into the vas deferens tubes — which carry sperm from the testicles to the penis — to block sperm. (Semen is composed of 10% sperm and 90% ejaculatory fluid, which is not interrupted during this process).

To insert the Intra Vas Device, a pinpoint opening is made in each tube to insert the plugs, a procedure that takes less than 20 minutes.

Dr. Pollock’s area of specialty is non-scalpel vasectomies, and Shepherd Medical — the U.S. based company that invented the IVD procedure — picked him to head its scientific advisory board.

Early tests in the United States and Brazil have indicated the procedure successfully blocks sperm in humans. Clinical trials involving monkeys found the same result.

“Generally, new research that will lead to an expansion of contraceptive options is definitely welcome,” Alexander McKay, research co-ordinator for the Sex Information and Education Council of Canada.

Still, Mr. McKay said more options are needed for women.

Nevertheless, he said the discovery could be important. “One of the potential problems with sterilization is that it is by and large irreversible. So with this type of contraception, assuming that it’s effective, the significance of it is that it is reversible.”

In the 1998 Canadian Contraception Study, which surveyed 1,599 women across Canada and was published in The Canadian Journal of Human Sexuality, two-thirds of females polled said they were aware of sterilization and thought highly of this birth control method.

Among married women, 24% of their male partners had been sterilized. Among unmarried women, just 1% of male partners had undergone a vasectomy.

“Single men generally don’t get vasectomies,” he said. “And so perhaps this new method would be something that would appeal to single men. Because if they subsequently decided to have children they could get it reversed.