Per the KQED feed on facebook, “Are you one of the millions of Americans living with pain? Pain that affects your job or family? Health Dialogues explores the mysteries and complexities of pain, from the latest research to pain relief and the attitudes taken toward pain. Tonight at 8pm on KQED 88.5FM.”

Go to http://www.kqed.org/ – it is currently the cover story. There’s a link on the right to listen live.

An audio archive should be available on January 22, 2010 at http://www.californiareport.org/archive/R201001212000/

‘Uterus transplant could be tomorrow’
11 November 2006 by Phil Mckenna
New Scientist Magazine issue 2577

“IF A person walked in tomorrow and requested a uterine transplant, I am cautiously optimistic that we could be successful.” So says Giuseppe Del Priore, of New York Downtown Hospital, who has approval for such a transplant from the hospital’s review board. He has potential donors lined up, and is interviewing women who would like to receive a donated uterus.

Thousands of women with perfectly good ovaries but lacking a functioning uterus would be interested. If a uterus transplant was carried out tomorrow, it would only be the second ever. Would it be safe? The first was in Saudi Arabia in 2000 and it failed.

Last month Del Priore and colleagues at the University of Pittsburgh’s primate research laboratory performed the first successful uterus transplant in a non-human primate. The recipient was a rhesus monkey and while it was only monitored for 20 hours its new uterus had a healthy blood supply and the drugs to prevent organ rejection appeared to be working.

Del Priore now plans to follow a pregnancy in such a monkey although he says it is not strictly necessary since enough work has been done to consider it a safe procedure for women. Face transplants, for example, were not first tried in other primates.

Not everyone shares his optimism – given the complex blood vessels that supply the uterus, the dramatic growth it undergoes during a pregnancy, and the possible effects of immunosuppressants on a fetus.

In September, Richard Smith, a gynaecologist at London’s Hammersmith Hospital, claimed he was two years away from carrying out a uterine transplant. And Mats Brännström of Gothenburg University, Sweden, who has been working on uterine transplants for six years, says, “We have to do a lot more animal studies before we go on to humans.” In 2002 his group carried out the world’s only uterine transplant that led to successful pregnancy, and that was in mice.

Brännström feels that transplanting a uterus into a women before a successful pregnancy in another primate would put prospective recipients at unnecessary risk. “It may be successful, but we should continue to optimise the procedure before trying it on humans,” he says. His group is hoping to attempt transplants using a live donor, so that the woman’s mother or a close relative could be used as a donor, reducing the need for immunosuppressants.

The first human transplant failed: although the woman had two periods the transplant had to be removed after less than 100 days when a blood clot formed in the connecting blood vessels. Del Priore plans to transplant more of the original blood vessels along with the donor uterus, which he says will reduce the chances of blood clots forming, and if the organ comes from a brain-dead donor whose heart is still beating higher doses of anti-clotting drugs can be used when the uterus is removed.

Peter Bowen-Simpkins at the Royal College of Obstetricians and Gynaecologists in London isn’t convinced. “It would be much better to know what happens when you first try to get a primate pregnant using a transplanted uterus before trying it in a human.”

However, he says that there seem to be no problems with the surgical procedures, if the transplant in monkeys was indeed a success – the results have yet to be published.

At present, the only option for a woman without a functioning uterus who wants her own child is IVF combined with surrogacy.

Scarring caused by surgical gel spray
Women are being hurt by a surgical treatment
LANE NICHOLS – The Dominion Post | Monday, 11 February 2008

A surgical gel – containing a drug untested on humans – has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.

Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.

Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.

Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.

Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet. But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm – even though the gel is considered high risk under proposed legislation.

Dr Koya – who first raised concerns in December 2005 – was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.

She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.

“Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used … [with] no quality assurance in terms of monitoring,” she wrote to Medsafe in December.

“It’s quite amazing – we’re using it inside human beings,” she told The Dominion Post. “I would have expected … that they would have said, `Let’s put this product on hold or start asking some questions’, but that didn’t happen.”

Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies – keyhole operations – jumped from less than 2 per cent to around 10 per cent.

Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations. Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring – which could cause infertility – even though their endometriosis had not returned. “It’s only where I’ve sprayed the SprayGel. It’s like sheets of scarring which I’ve never seen in my practice.”

Dr Koya said she had not repeated any laparoscopies since using an alternative product.

She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.

New Zealand distributor Covidien Tyco did not return calls.

Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine. No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.

After a review, it it concluded the gel was safe “when used as intended”.

There had been no other complaints and there were no plans to restrict its supply, it said.

DESIGNED TO HELP HEALING

What is Confluent SprayGel?

• Marketed as a synthetic, absorbable barrier to prevent tissue sticking together and forming scarring after abdominal pelvic surgery.

• A gel-based product containing methylene blue – a dye substance which is added to make it visible.
• Medsafe says methylene blue is already used widely in humans but is not approved for general supply as a medicine.
• The gel is in clinical trials in the United States but not approved for sale there.
• Approved for use in Australia and Europe.
• Sprayed on internal tissue. Usually absorbed within a week then excreted.
• Distributed in New Zealand till last month by Intermed Medical but now by Covidien Tyco.