Nearly 1 in 5 women who undergo hysterectomy may not need the procedure
JANUARY 06, 2015
Media Contact: Beata Mostafavi 734-764-2220

Study: Hysterectomies are declining overall but alternatives to hysterectomy are still being underutilized.

ANN ARBOR, Mich. —  A University of Michigan-led study of nearly 3,400 women in Michigan shows that one in five who underwent a hysterectomy for benign conditions may not have needed it.

The findings, which appear in the American Journal of Obstetrics and Gynecology, indicate that alternatives to hysterectomy are being underused and that treatment guidelines are often not followed.

An estimated one in three women in the U.S. will have had a hysterectomy by the age of 60.  Researchers found that although the numbers of hysterectomies are decreasing, nearly 18 percent of hysterectomies that were done for benign indications were unnecessary, and a pathology analysis for nearly two in five (38 %) of women under 40 did not support undergoing a hysterectomy.

“Over the past decade, there has been a substantial decline in the number of hysterectomies performed annually in the United States,” says senior author Daniel M. Morgan, M.D., associate professor in the Department of Obstetrics and Gynecology at the U-M Medical School.

“An earlier study found a 36.4% decrease in number of hysterectomies performed in the U.S. in 2010 compared to 2002. However, despite the decrease in numbers of hysterectomies in the U.S., appropriateness of hysterectomy is still an area of concern and it continues to be a target for quality improvement.”

More than 400,000 hysterectomies are performed in the U.S. each year. About 68% of surgeries for benign conditions are done because of abnormal uterine bleeding, uterine leiomyomata (fibroids), and endometriosis. The American Congress of Obstetricians and Gynecologists recommends alternatives to hysterectomy, including hormonal management, a minimally invasive gynecological procedure called operative hysteroscopy, endometrial ablation (a procedure that destroys the uterine lining) and use of an intrauterine device as primary management of these conditions in many cases.

Researchers set out to assess how often alternatives to hysterectomy are being recommended to women with benign gynecologic disease before performing hysterectomy and how often the pathologic findings from the hysterectomy supported an indication for surgery. They examined the medical records of 3,397 women who underwent hysterectomies for benign conditions in Michigan. Data were collected over a ten-month period in 2013 from 51 hospitals participating in the Michigan Surgery Quality Collaborative (MSQC). Indications for surgery included uterine fibroids, abnormal uterine bleeding, endometriosis, or pelvic pain.

Nearly 40% of women did not have documentation of alternative treatment before their hysterectomy. Fewer than 30% received medical therapy, while 24% underwent other minor surgical procedures before the hysterectomy. Alternative treatment was more likely to be considered among women under 40 years old and among women with larger uteri. About 68% of women under 40 received alternative treatment compared with 62% of those aged 40-50 and 56% of those aged 50 or above.

Nearly two in five women under 40 (38%) had pathologic findings that did not support undergoing a hysterectomy versus those aged 40-50 (12%) and over 50 years (7.5%). The frequency of unsupportive pathology was highest among women with endometriosis or chronic pain.

“This study provides evidence that alternatives to hysterectomy are underutilized in women undergoing hysterectomy for abnormal uterine bleeding, uterine fibroids, endometriosis, or pelvic pain,” Morgan says.

Additional Authors: Lauren Elizabeth Corona, of Wayne State University; and Carolyn W Swenson, M.D.; Kyle H Sheetz; Gwendolyn Shelby, R.N.; Mitchell B. Berger, M.D.; Mark D. Pearlman, M.D.; John O DeLancey, M.D., all of U-M. Darrell A. Campbell, Jr., U-M’s former chief medical officer. Pearlman and Morgan are also members of the U-M Institute for Healthcare Policy and Innovation. 

Funding: The MSQC is funded by the Blue Cross and Blue Shield of Michigan/ Blue Care Network.

Reference: “Use of Other Treatments before Hysterectomy for Benign Conditions in a Statewide Hospital Collaborative,” American Journal of Obstetrics & Gynecology, January, 2015.

Canadian endo sister forced to wait for laparoscopy – told she will “not suffer death or irreversible tissue damage”, so she should stop “doctor shopping, since this was a waste of both health-care resources and her time.” She was of course in agonising pain. Turns out once she came to the States to get surgery at Northside Hospital Cancer Institute, the surgeon had to remove her uterus, fallopian tubes, ovaries and nearly 8 inches of her bowel because of extensive endometriosis damage.

OHIP turns blind eye to suffering
COVERAGE: Area woman was chastised for seeking faster care before agency threw up roadblocks to paying for her care
By JONATHAN SHER, THE LONDON FREE PRESS
Last Updated: January 20, 2012 9:55pm

Chastened by doctors for seeking speedier treatment for a painful disease threatening to rob her of fertility, Allison Jones writhed with pain so severe it was like a man continually passing large kidney stones.

Jones needed to see one of a handful of gynecological specialists who could remove the lining of a uterus where it grows outside that organ, a painful condition called endometriosis.

But after waiting seven months to see a specialist Jones, a resident of Southwestern Ontario, was told she’d have to wait at least seven more for surgery that might make her pain-free for the first time in years.

Only one specialist held an open door to her care, a Canadian schooled almost entirely in Ontario. But Dr. Ken Sinervo had committed a Cardinal sin as far as OHIP was concerned — he offered life-changing surgery outside the country in Atlanta, Georgia.

Twice, Jones’ family doctor wrote to OHIP, asking the agency to pay for Siverno’s surgery, but each request was met by quick refusals and a suggestion she check a list of specialists, none of whom had time to see her any quicker.

One specialist, Dr. Sabrina Lee, chastised Jones for seeking faster access, writing in a letter she should stop “doctor shopping, since this was a waste of both health-care resources and her time.”

Jones sought emergency care repeatedly, but the heavy-duty drugs prescribed did little to curb her pain.

So in April of 2010, she decided to go to Atlanta.

Three days later, she was on an operating table at the Northside Hospital Cancer Institute.

“That’s one of the big differences between the health-care system in Canada and the system here,” Sinervo told The Free Press this week from Atlanta.

The disease had progressed so quickly, Sinervo had to remove her uterus, fallopian tubes, ovaries and nearly 8 inches of her bowel.

The ordeal was traumatizing. Jones — not her real name — asked The Free Press last week to keep her identity secret.

But those who helped her spoke out.

It isn’t just the speed of access that’s different, Sinervo says. The surgeries he performs in Atlanta are more advanced than what’s available in Ontario, in part because he performs surgery four or five days a week — while Ontario docs might get a day and a half because of the rationing of operating-room time.

“That’s one of the reasons I didn’t go back to Canada after my fellowship in Atlanta,” he said.

Sinervo uses a carbon-dioxide laser to remove all of the abnormal tissue to lessen the chance of complication and reoccurrences, something he says most specialists do not do.

The surgery was done, but the struggle for Jones had just begun: She faced a $70,000 medical bill including close to a week in hospital.

The Atlanta hospital, Northside Hospital Cancer Institute, later forgave most of the bill, wiping $57,000 off the books as it sometimes does for patients who just can’t afford to pay.

But OHIP fought against covering the remaining $13,000, even though that amount is almost certainly no more than what Jones’ treatment would have cost in Ontario, Sinervo said.

That hard-nosed approach is nothing new for OHIP, says the lawyer who represented Jones. For 20 years, the agency has acted strictly like a private insurance company, going to great lengths to avoid having to pay for any out-of-country care.

“There’s no compassion at all,” said Perry Brodkin, who was the agency’s in-house counsel years ago, before regulatory change changed it from an agency that tries to help to one seeking any reason to reject coverage.

Most patients lose appeals to OHIP rejections because they can’t afford to hire a lawyer, as legal costs typically range between $5,000 and $20,000.

Patients argue on compassionate grounds not to be found in a law that restricts out-of-country coverage to necessary care that’s unavailable here or so delayed a wait would probably result in death or medically significant and irreversible tissue damage.

Pain alone isn’t enough to get OHIP funding, no matter how excruciating or debilitating, Brodkin said.

But this time the bad guys lost, Brodkin said.

Jones won her appeal this month before Ontario’s Health Services Appeal and Review Board.

Board members took issue not just with the stance of OHIP, but also with the Ontario specialists who had essentially told Jones to wait her turn.

The specialist she was to have waited for was Dr. Nicholas Leyland, top dog at Health Sciences Centre at Hamilton’s McMaster University.

But when Jones went to Sinervo, Leyland wrote to support OHIP’s denial of coverage.

“We could have carried out the same kind of care that was provided by Dr. Sinervo, who was a trainee of ours a few years ago. This patient would not have suffered death or irreversible tissue damage in waiting for this surgery. Many patients are waiting for this procedure much longer,” Leyland wrote.

The board rejected Leyland’s claim, noting in his letter, he didn’t mention Jones’ specific condition or if delay would cause irreversible tissue damage, dismissing her claim because some other women with the same general condition had to wait longer.

“It is unfortunate that Dr. Leyland did not testify at the hearing,” the board wrote.

The board also took aim at OHIP: “The Appeal Board is troubled by (OHIP’s) assertion that since endometriosis is by definition a progressive disease, any further progression in the form of tissue damage is expected and is not medically significant.”

The decision is timely, Brodkin said, as waits for surgery by Leyland have grown to nine months, with about 60 women affected.

“Most wait and suffer damage,” he said. “(This case) may open the doors (for care in Atlanta),” Brodkin said.

The Toronto lawyer challenged Ontario Health Minister Deb Matthews to change the rules and process to give patients a fighting chance, even if it’s to arrange for an advocate or ombudsperson for those who can’t afford a lawyer.

As for Sinervo, he’d like to negotiate a reduced rate with the health ministry for Ontario women going to Atlanta’s Center for Endometriosis Care, something close to half of the regular charges.

The Free Press requested interviews three days this week with Matthews, a London MPP, but she didn’t make herself available.

Messages left for Leyland and Lam also weren’t returned.

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.