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Power Morcellator injuries Fibroids,hysterectomys & cancer links & the FDA

#1 User is offline   hukildaspida 

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Posted 11 December 2014 - 01:36 PM


Power Morcellator News:
Bernstein Liebhard LLP Notes New Report Highlighting Financial Ties Between FDA Advisors, Morcellator Manufacturers
PR Newswire
Bernstein Liebhard LLP 6 hours ago

http://finance.yahoo...-184100983.html

NEW YORK, Dec. 10, 2014 /PRNewswire/ -- A new investigation by The Wall Street Journal has raised serious questions about the financial ties between certain U.S. Food & Drug Administration (FDA) advisors and the manufacturers of power morcellators http://www.morcellatorlawsuit2015.com) , Bernstein Liebhard LLP reports. According to a December 9th report, the FDA did not disclose that Keith Isaacson, a doctor who served on the agency's morcellator panel in July, had been paid $12,000 in consulting fees from Johnson & Johnson in 2013, which until recently had marketed morcellators via its Ethicon, Inc. unit. Dr. Isaacson also received payments of about $9,500 from Johnson & Johnson from 2010 through 2013. From 2009 to 2013, he was paid $148,400 in consulting fees and other compensation from Karl Storz, another manufacturer of power morcellators.*

View photo
.
Bernstein Liebhard LLP

This is not the first time The Wall Street Journal has uncovered financial ties between morcellator manufacturers and FDA advisors. As the December 9th article notes, Dr. Andrew Brill recused himself from the FDA's panel just days before the July morcellator meeting, after the Journal revealed that he had received $100,000 in consulting fees from Johnson & Johnson in 2013.

"FDA advisors often make recommendations that could have adverse financial consequences for device manufacturers. As such, advisors' financial ties to those device manufacturers should at least be disclosed before a panel hearing," says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancers following uterine morcellation.

Power Morcellators and Cancer
Power morcellators are used in laparoscopic hysterectomy and fibroid removal procedures to shred tissue so that it may be removed via a small abdominal incision. In a new morcellator cancer warning issued on November 24th, the FDA cautioned against using morcellators in women who are entering menopause, as well as those who have already been through menopause. The FDA also advised against such procedures for women who are good candidates for intact removal of the uterus, either through the vagina or via a procedure known as a mini-laparotomy. These contraindications would apply to the vast majority of women who require hysterectomy or fibroid removal, the FDA said.

In its latest alert, the FDA noted that there is no reliable way to screen for malignancies before a woman undergoes uterine morcellation, and dissemination of cancer cells via a power morcellator can upstage the disease and greatly reduce a woman's chance of long-term survival. The agency estimated the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or fibroid removal surgery is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498..

As The Wall Street Journal article notes, Dr. Isaacson was among the FDA panel members who questioned the FDA's data regarding the prevalence of uterine sarcoma among women with fibroids.*

Women who allegedly experienced the spread of uterine sarcoma or other cancers due to a power morcellator may be able to take legal action against the manufacturer of the device. To learn more about the risks potentially associated with uterine morcellation, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call (888) 340-4807.
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#2 User is offline   hukildaspida 

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Posted 11 December 2014 - 01:42 PM

FDA Warns Of Cancer Risk With Uterine Fibroid Surgery Tool

By Igor Kossov

http://www.law360.co...id-surgery-tool

Law360, New York (November 24, 2014, 2:35 PM ET) -- A surgical device may spread cancer and shouldn't be used in gynecological surgery that involves cancer or fibroids, the U.S. Food and Drug Administration said in a Monday guidance update.

The communique is a sharp warning against the use of laparoscopic power morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal. The FDA said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.


“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” Dr. William Maisel, FDA's deputy director for science, said in a statement.

The FDA warned against the use of such tools earlier this year, but its latest warning was more urgent. The controversy over the tool's danger prompted Johnson & Johnson unit Ethicon Endo-Surgery Inc. to execute a worldwide recall of its Morcelex brand devices in July. Ethicon had suspended sales of the devices in April.

Laparoscopic power morcellation, one technique used to treat non-cancerous fibroids as well as in some hysterectomy procedures, uses a device to break targeted tissue into fragments that can be removed through an incision in the stomach, according to the FDA.

Of the 500,000 hysterectomies performed every year, about 11 percent are done using this method, according to the FDA.

Although uterine fibroids are common and usually benign, about 1 in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, a type of uterine cancer, according to the agency said.

The FDA said that there are other surgical treatment options available to women with fibroids, such as traditional surgical hysterectomy, laparoscopic hysterectomy and myomectomy without morcellation, as well as laparotomy using a smaller incision.

In May, Ethicon was hit with the first suit over the product in New York federal court. Plaintiffs Brenda Leuzzi and George Leuzzi claim that she was diagnosed with cancer after undergoing a robot-assisted hysterectomy with morcellation in 2012 and that the company did not adequately test its Morcelex product for potentially dangerous side effects.

Later, Peggy Paduda of Florida sued Karl Storz Endoscopy-America, which makes morcellator devices as well. Doctors used one to remove fibroids from her uterus, which allegedly spread endometrial stromal sarcoma, a type of cancer, throughout her abdominal cavity.

--Additional reporting by Kurt Orzeck. Editing by Patricia K. Cole.

Related Articles

J&J Unit Recalls Hysterectomy Device Over Cancer Fears
FDA Warns Of Cancer Risks With Fibroid Removal Procedure
J&J Unit Faces 1st Morcellator Suit Since FDA Warning
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#3 User is offline   hukildaspida 

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Posted 11 December 2014 - 01:44 PM


Hospital Chain HCA Prohibits Power Morcellation for Uterine Fibroids


http://www.wsj.com/a...oids-1416948061

Hospital Network Says Tool Shouldn’t Be Used in Vast Majority of Women Undergoing Fibroid Surgery
A doctor holding a morcellator. ENLARGE
A doctor holding a morcellator. Dustin Chambers for The Wall Street Journal
By
Jon Kamp
Updated Nov. 25, 2014 3:52 p.m. ET
5 COMMENTS

One of the nation’s largest hospital networks said Tuesday it is halting use of a power tool commonly used in gynecological surgery after the U.S. Food and Drug Administration warned it can spread cancer.


The move by HCA Holdings Inc., a for-profit chain with about 160 hospitals and 115 surgery centers in 20 states, marks one of the first significant shifts around the laparoscopic power morcellator since the FDA warning. The agency said Monday the tool shouldn’t be used in the “vast majority” of women undergoing surgery for common growths called fibroids because the procedure could spread and worsen hidden cancers.

“We are implementing a prohibition of the use of power morcellation in laparoscopic uterine surgery,” an HCA spokesman confirmed Tuesday in an email. The implementation is under way and applies to all of the hospitals and surgery centers, he said.

Previously, the hospital company had strongly recommended doctors follow the FDA guidance issued in April, when the agency discouraged morcellation procedures. It wasn’t immediately clear if the chain’s hospitals and doctors had been using morcellators regularly.

Related

5 Questions About the FDA Warning
Cancer-Risk Debate Didn’t Halt Surgeries
A Medical Device Is Sidelined, but Too Late for One Woman (11/21/14)
How Surgical Robots Spurred Morcellator Use
What to Know — The Short Answer
Answers for Women With Fibroids
Gynecologists Resist FDA Over Popular Surgical Tool (9/21/14)
Johnson & Johnson Pulls Hysterectomy Device From Hospitals (7/29/14)
Doctor Quits Uterine-Device Safety Panel Over Conflict (7/10/14)
Women’s Cancer Risk Raises Doubts About FDA Oversight (7/8/14)
FDA Advises Against Morcellator Use in Hysterectomies (4/17/14)
How Morcellators Simplified the Hysterectomy but Posed a Hidden Cancer Risk (4/11/14)

Morcellators, drill-shaped tools that typically use a spinning blade, have been around since the early 1990s and help doctors perform minimally invasive procedures by cutting up fibroids for removal through small incisions. The devices were used in thousands of hysterectomies and fibroid removals every year.


The FDA beginning investigating the cancer-spreading risk in December, after The Wall Street Journal wrote about a Boston doctor’s own case of worsened cancer after a morcellator-aided hysterectomy. The review led to the April advisory, a firestorm of debate in the gynecology field and moves by many hospitals and some regional insurers to curtail these procedures.

The FDA’s new warning is expected to ratchet up the pressure. The agency called on morcellator makers to immediately add a new “black-box” warning on product labels telling doctors and patients that uterine cancer can contain hidden cancer that morcellators can spread and worsen. The FDA also called for new product language explaining that power morcellators shouldn’t be used for removing fibroids in women who are transitioning into or already went through menopause, or women who could have their uterus removed intact through their vaginas or an incision called a minilaparotomy. This covers most women with fibroids who have hysterectomies and fibroid-only procedures, the FDA said.

The agency didn’t ban morcellators outright—as some device opponents demanded—because it said procedures with the devices may still be appropriate for some patients such as young women trying to preserve their uterus so they can have children. Data indicate these women face a lower risk of cancers that can’t be detected with certainty before surgery.

Write to Jon Kamp at [email protected]
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#4 User is offline   hukildaspida 

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Posted 11 December 2014 - 01:48 PM

How many women in NZ have had Power Morcellator treatment that has resulted in injury?

Has anyone had a successful http://www.acc.co.nz claim that has been harmed by the use of such a device?

What steps has the NZ government taken to ensure these devices are banned or restricted in there use?

It would be interesting to know how many women have passed away of cancer that have had operations where a Power Morcellator has been used.

Maybe families that have lost loved ones should be requesting medical files and asking some serious questions.

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#5 User is offline   hukildaspida 

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Posted 12 December 2014 - 11:07 AM

Contraceptive device inserted without consent
JOSH FAGAN
Last updated 19:47, December 8 2014

http://www.stuff.co....without-consent

An Auckland woman was unable to have children because a doctor inserted a contraceptive device in her uterus without her knowledge.

The intrauterine contraceptive device was inserted when the woman went to Epsom Day Unit to have an abortion in 2010. She had not consented to having it and it was only in 2013 that she discovered it, after unsuccessful attempts to get pregnant.

An investigation by the Health and Disability Commissioner found the doctor mistakenly "assumed" the woman wanted the contraceptive device after seeing it on a hospital trolley.

The surgeon has now apologised to the woman but the Health and Disability Commissioner Anthony Hill damned the doctor and the hospital, saying they "failed to provide services with reasonable care".

Both the operating surgeon and the Auckland District Health Board were found to be in breach of the Code of Health and Disability Services Consumers' Rights,
the decision released today, stated.

Hill has called on the Auckland District Health Board to also apologise.

The investigation found the doctor did not check if the woman consented to having the device.

The surgeon "erred in assuming that because a nurse had placed an IUCD on the instrument trolley during the procedure, she had in fact consented to the IUCD", the decision said.

According to the Ministry of Health website an IUCD has a 99 per cent effectiveness rate at preventing pregnancy and can stay in place for five years.

It is placed inside the uterus and works by preventing fertilisation of the egg. It is usually recommended for women over 25 who have had a baby, the ministry said.


The woman made the discovery of the IUCD after visiting her GP in early 2013, having attempted to become pregnant for the past five to six months without success.

She underwent various tests, including a smear test and her GP identified and removed the IUCD.

HOSPITAL DENIED IT DID ANYTHING WRONG

The Auckland District Health Board's initially denied any wrongdoing, saying there was "no suggestion the treatment provided was of concern".

It said the woman suffered no physical injury or permanent harm, and described the inconvenience to her as brief.

"The issue is failure to obtain consent in one case amongst thousands of similar cases," its submission to the commissioner said. "In this case and the thousands of IUCD procedures [where] consent was obtained the clinical outcome was achieved with reasonable care and skill."

The board also failed to provide a formal apology letter, which they indicated they would send after the initial complaint was raised.

No letter arrived, despite the woman emailing twice more to ask of its status. The decision said she felt like the complaint was not being taken seriously and Hill agreed, saying the board's response "was unfortunate and added to (her) distress".

The woman said the incident caused her to suffer stress and disappointment each month when she did not become pregnant. She also spent money on pregnancy vitamins, pregnancy tests, ovulation kits, doctor's visits and various other matters while trying to conceive.

A Health and Disability Commissioner spokeswoman said questions of financial compensation would have to be raised by the woman directly to the Auckland District Health Board.

The board did not immediately respond to requests for comment.

Epsom Day Unit is the largest provider of TOP (termination of pregnancy) services in New Zealand.

About one third of patients who have an abortion have an IUCD inserted.

Auckland District Health Board told the commissioner there was no policy - written or unwritten - that encouraged or required women to have an IUCD inserted following an abortion.

After the procedure there was no evidence that the IUCD was inserted.

The only indication in official records was on page six of a patient file that had a partial dash in a yes column next to a heading that said "CU 375 /Mirena".

When the doctor was first asked about the incident he said he did not recall the woman and did not know how the error occurred. He said he thought a nurse placed an IUCD on the instrument trolley, which he then inserted.

As a result of the bungle, Epsom Day Unit has changed its processes to ensure correct procedures are performed on the correct patient.

Hill said the consent system that allowed the error was inadequate.

He said the proper procedure was to "ensure that patients do not receive treatment that they have elected not to receive."

Hill has recommended the Auckland District Health Board arrange a records-based review for patients randomly selected for the first three months of 2010, 2012 and 2014, to identify any inconsistencies apparent from the records of those patients.

The Board has been asked to report back to the Commissioner on the findings of those audits.

Wellington ACC lawyer John Miller said failing to obtain consent is a treatment injury under ACC.

He said there were questions around whether having a foreign object inside you was considered a personal injury, but there could be other claims of ongoing mental impairment.


"If there are now difficulties conceiving because of having the IUCD in so long then treatment including assistance with getting pregnant could be available though ACC,"
he said.

The option to sue for damages through the courts was also open to her, he said.

- Stuff
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#6 User is offline   hukildaspida 

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Posted 12 December 2014 - 02:58 PM

Wednesday 22 Oct 2014

US warns against womb surgery tool – why is it still in use here?

- See more at: http://blogs.channel...h.3B7n0ytk.dpuf

Doctors have said a method used to remove fibroids in the womb by keyhole surgery, may be putting women’s lives at risk.


Already the Food and Drug Administration in the United States has issued a warning against using a tool called a power morcellator, which shreds the fibroids, making them easier to remove from the womb. And one manufacturer has withdrawn its morcellator from the market after a study claimed that one in every 350 women who has fibroids removed by this method, has a hidden cancer called a sarcoma.

- See more at: http://blogs.channel...h.3B7n0ytk.dpuf

In England, the National Institute for Health and Care Excellence (Nice) has told Channel 4 News that it will be reviewing its guidance in the new year.

Sarcoma’s are rare cancers and those that grow in the lining of the uterus can be masked by the fibroids. It is believed that if a morcellator is used, it causes cells from that sarcoma to spread, leading to secondary cancers.

The problem is a disagreement in the medical profession about the level of risk. Professor Ian Judson, a consultant medical oncologist and expert in sarcomas at the Royal Marsden Hospital in London, said the evidence appeared to show an increased risk in women over the age of 50.

He also said research now showed that if a morcellator had been used, the average time it took to recur appeared to be faster and the risk of death increased.

“We need more data,” Professor Judson told Channel 4 News. “In the meantime, until we can reach agreement I think there should be a moratorium on their use.”

Debate over data


There are those who disagree. The British and European societies of gynecological endoscopy acknowledge the concerns over power morcellation. However, they say, the data is poor and the risk of a fibroid being a sarcoma is very rare.

Thomas Ind, consultant gynecological surgeon
, said that they believed the risk was one in 1,300 – not the one in 350 that the FDA has claimed.

“What one has to be concerned about is that one doesn’t over react and withdraw the instrument from women who will benefit from it,” Mr Ind said. “So the first thing we have to consider is what the incidence – or likelihood is. Women who have fibroids removed for fertility, the incidence is very low, certainly under the age of 40 it is extremely rare.”

He said minimally-invasive surgery for a condition that can be painful and lead to infertility, must be weighed up against the rarity of sarcomas.

However, the charity, Sarcoma UK, is also calling for morcellators to be withdrawn until a consensus can be reached.

Older women


In the meantime, doctors are in agreement that women should be advised that there may be a risk and that if they are older, then it would be safer not to use the tool.

Prof Judson said there also needed to be greater awareness of the symptoms of sarcoma: sudden growth of the fibroid, pain and post-menopausal bleeding.

One of the manufacturers of a power morcellator, just sent this statement.

“While our devices have always carried a warning about the potential spread of cancerous tissue, as new information and questions have begun to arise, there has been growing uncertainty about the potential risk of the procedure,” said Matthew Johnson, communications director at Ethicon. “Because there is no consensus in the medical community about the rate of this relatively rare form of cancer that may be spread after morcellation, we elected to suspend sales and then to voluntarily withdraw our devices from the marketplace.”

For more information, visit the Sarcoma charity website.
http://sarcoma.org.uk/

Follow @vsmacdonald on Twitter
- See more at: http://blogs.channel...h.3B7n0ytk.dpuf
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#7 User is offline   hukildaspida 

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Posted 12 February 2015 - 01:06 PM

FDA warns against using laparoscopic power morcellators to treat uterine fibroids

Agency recommends adding important safety information to product labels
For Immediate Release

http://www.fda.gov/N...s/ucm424435.htm

November 24, 2014
Release

Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.

In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

The boxed warning informs health care providers and patients that:

Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

The two contraindications advise of the following:

Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

The IIE guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecological indications.

Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

The two contraindications help to clarify the narrow population of patients in which laparoscopic power morcellation may be an appropriate therapeutic option. For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may be candidates for this procedure.

“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” said Dr. Maisel.

There are other surgical treatment options available for women with symptomatic uterine fibroids, such as traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy).

In addition to the original safety communication and quantitative analysis, in July 2014 the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel to discuss patient populations in which laparoscopic power morcellators should not be used, specifically mentioning patients with known or suspected malignancy. The panel also discussed mitigation strategies such as labeling and suggested that a boxed warning related to the risk of disseminating unsuspected malignancy would be useful. The panel indicated that it is critical that doctors discuss the risks and benefits of all options with their patients.

In addition to the updated safety communication and IIE guidance, the FDA is considering other ways to further help reduce the risk of unsuspected cancer spread by laparoscopic power morcellation, such as encouraging innovative ways to better detect uterine cancer and contain potentially cancerous tissue.

The agency will continue to review adverse event reports, peer-reviewed scientific literature and information from patients, health care professionals, gynecologic and surgical professional societies and medical device manufacturers and may take further action in the future, if necessary.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Related Information

Updated FDA Safety Communication: Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy, November 2014
Recommended Labeling Statements for Laparoscopic Power Morcellators (PDF - 151KB)
National Institutes of Health: Uterine Fibroids Fact Sheet, March 2013

Page Last Updated: 11/24/2014
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#8 User is offline   hukildaspida 

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Posted 12 February 2015 - 01:24 PM

In The Guidelines for Heavy Menstrual Bleeding Working Party Report in 2001, it states how many women in New Zealand have had hysterectomys and fibroid related type of operations.

How many of these women had undetected cancers that resulted in death?

How many of these women have undetected cancers as a result of power morcellation treatment?

Page 12 of this report states there used to be 7000 hysterectomies performed annually in NZ.

Perhaps those that have been through this treatment process should be requesting there files from all of those involved in their care and treatment.




http://www.moh.govt....%20bleeding.pdf
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#9 User is offline   hukildaspida 

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Posted 20 February 2015 - 02:38 PM

BRIEFING
September
2014
Uterine sarcoma and power morcellation to treat fibroids

http://sarcoma.org.u...iefing23Oct.pdf
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#10 User is offline   hukildaspida 

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Posted 18 June 2015 - 04:50 PM

U.S.

Aetna to Stop Covering Routine Use of Power Morcellator
Power Morcellation Can Spread Hidden Cancer in Women, Regulators Say

By
Jon Kamp
Updated May 5, 2015 10:24 p.m. ET

http://www.wsj.com/a...ator-1430838666

Aetna Inc. will stop covering routine use of the laparoscopic power morcellator this month, marking the most direct blow from a major health insurer to a surgical tool that regulators determined can spread hidden cancer in women.

The nation’s third-largest health plan with about 23 million medical members, Aetna will implement its new policy starting May 15, a spokeswoman said. Power morcellation—which is used to remove common uterine growths called fibroids, often in hysterectomies—won’t be covered under most circumstances, the spokeswoman said.


Earlier Coverage

How Suspect Device Got Surgeon Group’s Blessing (Feb. 17)
How Surgical Robots Spurred Morcellator Use (Nov. 21)
Gynecologists Resist FDA Over Popular Surgical Tool (Sept. 21)
Johnson & Johnson Pulls Hysterectomy Device From Hospitals (July 30)
Doctor Quits Uterine-Device Safety Panel Over Conflict (July 10)
Women’s Cancer Risk Raises Doubts About FDA Oversight (July 8)
FDA Advises Against Morcellator Use in Hysterectomies (April 17, 2014)
How Morcellators Simplified the Hysterectomy but Posed a Hidden Cancer Risk (April 11, 2014)
Deadly Medicine: A Common Surgery for Women and the Cancer it Leaves Behind (Sept. 2014)

The tools are used in minimally invasive surgeries to cut bulky growths or the uterus into pieces so they can be removed through tiny incisions. But dangerous cancers can masquerade as benign fibroids and can be spread by a morcellator’s spinning blade, significantly lowering a woman’s chance of survival.

The U.S. Food and Drug Administration warned last year that women undergoing fibroid surgery have an estimated 1 in 350 risk of harboring the cancers called sarcomas, which was a much higher rate than had been generally realized.

In November, the FDA said power morcellators shouldn’t be used on the vast majority of women. The agency also called on device companies to immediately add a “black-box” warning about the risk.

Aetna said it will require doctors to obtain prior approval for any procedure that would involve use of the device. Doctors can request exceptions for pre-menopausal women who want to preserve fertility and have no other effective option or women for whom another type of procedure could be life-threatening or lead to severe complications, Aetna spokeswoman Cynthia Michener said.

“The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis,” Ms. Michener said. The company said it is urging doctors to talk to patients about the risks and benefits of morcellation, as well as alternatives.

The Hartford-based insurer is the largest managed-care firm to take direct action against power morcellators, although the move is part of a tapestry of insurer efforts that are steering doctors and patients to other procedures. Nationwide, Aetna and other health plans covering about 93 million Americans have either curtailed use of morcellators or are considering limits.

This includes Health Care Service Corp., the fourth-largest U.S. insurer, which has proposed labeling power morcellation “not medically necessary” starting June 1, which means the procedure typically wouldn’t be eligible for coverage. The insurer opened the draft policy to comments and is still reviewing the issue, a spokeswoman said.

Elsewhere, number two insurer Anthem Inc. set a prior authorization requirement for all hysterectomies last year but doesn’t have a policy specific to morcellation. Several smaller insurers have halted coverage of morcellation.

While many hospitals have banned or limited morcellators, and the former largest manufacturer, Johnson & Johnson, left the market last year, devices from other companies remain on sale. The FDA opted not to ban the tools, but doctors are moving away from their use.

Write to Jon Kamp at [email protected]
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#11 User is offline   hukildaspida 

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Posted 18 June 2015 - 04:52 PM

Unnecessary surgery? Research reveals some women can wait to remove fibroids
Posted 5:39 pm, May 21, 2015, by Zaneta Lowe

MEMPHIS, Tenn. — They’re as common as a mole yet there’s so much we still don’t know about uterine fibroids, or typically benign tumors that grow inside a woman’s uterus.

“Virtually everybody forms a fibroid eventually,” said Dr. Katherine Hartmann, an OB-GYN and epidemiologist, at Vanderbilt University Medical Center.


Dr. Hartmann also served as the Associate Dean for Clinical & Translational Scientist Development and the Deputy Director for the Institute of Medicine and Public Health at VUMC.

After looking at images and pouring over the electronic medical records of thousands of women, her research showed more than 95% of black women and more than 90% of white women form a fibroid at some point.

“African-American women tend to get fibroids younger and form more. White women tend to have the initial fibroid form later and to form fewer, but we all arrive in a similar place by the time of menopause,” said Hartmann who has researched and published countless papers regarding women and fibroids.

Dr. Hartmann said they also learned black women, past a certain age, have higher rates of intervention, particularly hysterectomy.

Maudie Catron eventually had a robotic hysterectomy.

“You just can’t take the pain anymore,” said Catron about the worst of her symptoms which also included heavy bleeding and anemia.

She opted for the hysterectomy after having two myomectomies and fibroid embolization.

Two of her sisters had similar procedures.

Her grandmother died during childbirth.

“I was always asking them was it hereditary and they told me no,” Catron said.

Which leads to the question all women want the answer to: What causes fibroids?

When we asked Dr. Hartmann, she said because fibroids were so common, it has become a difficult research question.

However genetics was changing the game.

“We’re about to turn that on its head and ask the other question, which is how do these other women, these five percent, these two to six-percent across racial groups, how do they avoid forming a fibroid?” she asked.

That answer is likely years away, but what Hartmann already learned could change treatment options for women like Catron and her sisters.

“If they don’t affect your quality of life or it’s not the right time, or you have child bearing considerations or other things, wait,” Dr. Hartmann advised.

Watchful waiting.


Dr. Hartmann told WREG generations of women didn’t hear that message from their physician, and now there’s even more proof that surgical intervention for younger women with fibroids may not be necessary.

Right From the Start was a study of more than 8,000 pregnant women without fertility issues across the country.


The women underwent ultrasound early in the pregnancy.

Among many things, the study closely examined the effects of fibroids on a woman’s pregnancy.

Hartmann said one common myth was that fibroids change a woman’s ability to conceive.

While this can certainly be true for women who suffer from other infertility issues, Dr. Hartmann said it’s different with fibroids.

“That unfortunately got generalized to all women everywhere. That maybe getting your fibroids removed could help with conception.”

A move Hartmann said may not be necessary.

Their study showed women with fibroids didn’t have a harder time getting pregnant.

“For an uncomplicated pregnancy in an otherwise healthy woman, in the middle of her reproductive age span, don’t stress about that fibroid,”said Hartmann of the cue women should take from that research.

Hartmann’s research also debunked another common myth which was that pregnancy hormones feed the fibroid and caused them to get bigger.

They found some fibroids actually got smaller during pregnancy.

Also, among their participants, there was only a slightly higher risk of having a cesarean.

Of the group, women with larger fibroids had the highest risk.

“It allows women and their providers to relax more, about not jumping the gun,” Dr. Hartmann said. “Let’s not schedule a cesarean, let’s see how it goes.”

Hartmann said the take away was for women to explore their options, talk to their doctors about treating the symptoms, and opt for surgery as a last resort.

It’s what Catron did and she’s glad to have gone that route.

“He waited until I was ready so there was always options for me,” she said.

Phase two of Right from the Start will begin soon which will examine treatment methods the women had to remove their fibroids.

Another study, led by a team at Duke University, is underway that will build a national, patient registry of more than 10,000 women having treatment for fibroids.

Recruitment will begin this summer and one of the participating hospitals is the University of Mississippi Medical Center in Jackson.

Filed in: News, On Your Side

Topics: Dr. Katherine Hartmann, Fertility, fibroids, health, Maudie Catron, PCORI, Pregnancy, Right From the Start, Surgery, Treatment Options, uterine fibroids, Vanderbilt University Medical Center, women
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Posted 18 June 2015 - 04:53 PM

Right from the Start fibroid study

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Hum Reprod. 2012 Oct; 27(10): 2991–2997.
Published online 2012 Jul 18. doi: 10.1093/humrep/des263
PMCID: PMC3442631
Uterine leiomyomata and fecundability in the Right from the Start study
Gayle Johnson,1 Richard F. MacLehose,1,2,* Donna D. Baird,3 Shannon K. Laughlin-Tommaso,4 and Katherine E. Hartmann5,6

http://www.ncbi.nlm....les/PMC3442631/

Abstract
BACKGROUND

Previous research suggests the removal of uterine leiomyomata may improve ability to conceive. Most of this previous research was conducted in infertility clinics. We investigated the association between leiomyoma characteristics on time to pregnancy among women enrolled from the general population.
METHODS

We enrolled a cohort study of women in early pregnancy. Participants retrospectively reported their time to conception. Leiomyomata characteristics were determined by first-trimester ultrasound. We used discrete time hazard models to estimate the effects of uterine leiomyomata on time to pregnancy.
RESULTS

In this population of 3000 women, 11% (324) with one or more leiomyomata, we found no association between leiomyomata presence, type, location, segment or size on time to pregnancy.
CONCLUSIONS

These results suggest that leiomyomata have little effect on time to pregnancy in this cohort of women. The study excluded women who had been treated for infertility, and this may have resulted in underestimation of the association. However, differences between our study and previous studies in specialty clinics may be, in part, attributable to differences between our community-recruited population of women and women receiving fertility care, as well as difference in leiomyomata size or type in women having myomectomies to treat infertility.
Keywords: leiomyoma, pregnancy, epidemiology
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Introduction

Uterine leiomyomata, or fibroids, are an important health concern among women in the USA. They develop in 70–80% of women and are symptomatic in ∼25% of women (Baird et al., 2003). By age 35, uterine leiomyomata are detected by imaging in over 60% of black women and ∼40% of white women; further, the prevalence increases with age (Baird et al., 2003). The Right from the Start (RFTS) study documented an overall prevalence of leiomyomata of 18% among black women and 8% among white women using screening ultrasound during the first trimester of pregnancy, with the lower prevalence likely due to the lower age of pregnant women (mean age = 28.7 years; Laughlin et al., 2009). Previous research indicates leiomyomata may be associated with an array of reproductive outcomes, including infertility, reduced fecundability, miscarriage, preterm delivery and placental abruption (Muram et al., 1980; Farhi et al., 1995; Benson et al., 2001; Sheiner et al., 2004; Shokeir, 2005; Klatsky et al., 2008). These adverse outcomes make leiomyomata of particular importance to women of childbearing age in the USA.

Leiomyoma status may be associated with ability to conceive. Case-series report improved probability of conception in previously infertile women who have had leiomyomata removed by myomectomy (Bajekal and Li, 2000). The majority of information concerning the impact of leiomyomata on fecundability, however, comes from fertility clinics, in which pregnancy rates between women with and without leiomyomata are compared, and typically show a somewhat decreased fertility among women with leiomyomata (Hart et al., 2001; Wang and Check, 2004). These previous studies have often been conducted in small, highly selected populations of women seeking specialty care and have typically assessed whether the removal of clinically significant leiomyomata resulted in improved fertility and response to assisted reproductive technologies. Questions remain, however, about the generalizability of the results to the average woman planning a pregnancy. To our knowledge, no community-based study has examined the association between leiomyomata and fecundability.

Mechanisms by which uterine leiomyomata could impair fertility are speculative. Some hypotheses are based on uterine architecture: leiomyomata could distort the uterine cavity and obstruct sperm transport (Hunt and Wallach, 1974), they could block or damage utero-tubal junctions (Vollenhoven et al., 1990) or affect movement through the uterus. Others are grounded in molecular physiology: leiomyomata may cause inflammation of the endometrium or produce chemicals reducing blood vessels in the surrounding area creating poor implantation sites (Hunt and Wallach, 1974; Donnez and Jadoul, 2002). Any of these mechanisms could interfere with sperm transport, embryo implantation or quality of placentation thereby preventing pregnancy or promoting very early pregnancy loss before recognition of pregnancy. If uterine leiomyomata reduce fecundability or increase the risk of very early pregnancy loss, it is expected that the reported time (number of menstrual cycles) to conception would be greater for women with uterine leiomyomata than for women without leiomyomata. Leiomyoma characteristics, such as location, number and size, could also impact fecundability (Klatsky et al., 2008). We investigated the association between the presence of leiomyomata as well as leiomyoma characteristics on reported time to pregnancy in a retrospective analysis of data from a large cohort of women who were able to conceive.
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Materials and Methods

Right from the Start (RFTS) is an ongoing cohort study of pregnancy outcomes that has included women from four metropolitan areas in three states (North Carolina, Tennessee and Texas).

The four academic institutions provided institutional review board approval. Recruitment strategies included newsletters, advertisements, direct home mailings and print material in community practices. The recruitment strategies mentioned only pregnancy outcomes and did not specifically mention leiomyomata or fertility (Promislow et al., 2004).

Eligible women were older than 17 years, spoke English or Spanish, did not plan to move from the study area within the next 18 months, enrolled before 13 weeks gestation based on last menstrual period, did not use assisted reproductive technology or ovulation inducing medication and intended to carry the pregnancy to term. Women could enroll in the study for more than one pregnancy, but only the first enrollment was included in this analysis.

Upon enrollment, women completed a computer-assisted telephone interview that included questions about demographic characteristics, health behaviors and medical and reproductive history, women self-reported race and ethnicity. The interview also asked women whether they became pregnant within the first, second or third menstrual cycle; if not within three cycles, they were asked to estimate the number of cycles, months or years that it took them to conceive. We treated months and cycles as equivalent in all analyses.

The time-to-pregnancy data among women who enrolled very early in the study were left truncated to take into account that women were only eligible to enroll in the study if they were in the first trimester. Time-to-pregnancy months that were accrued prior to 3 months (approximate length of first trimester) before the date that the study began at that site were left truncated. For example, if a woman reported trying to conceive for 6 months before the study start date, her first 3 months were truncated from the analysis and she would start accruing person-time during her fourth cycle of her time to pregnancy. Because of the retrospective design of the study, this hypothetical woman would not have been eligible to enroll had she become pregnant in her first three cycles because she would have been in the second trimester by the time the study began. These cycles that occurred prior to 3 months of study initiation are cycles during which a woman who ended up enrolling in RFTS could not have conceived and are therefore excluded from analysis. If a woman accrued all of her cycles attempting to become pregnant prior to this date, she was excluded from the study (n = 78). Though we present results from this design, the results did not change when all time-to pregnancy data were included with no left truncation.

Baseline interview data were available for the first pregnancy of 4683 women. Women were excluded from the analysis if they had not intended to become pregnant and therefore could not provide us with information about how long they had attempted to conceive (n= 1176); did not provide information on whether they were attempting to become pregnant (n= 12); did not provide information on the number of cycles it took them to conceive (n= 268) or did not have ultrasound data (n= 319). These exclusions resulted in 3000 women with person-time eligible for the analysis.

Participants were all scheduled as early as possible for endovaginal ultrasonography (supplemented if needed by transabdominal images) starting at the sixth week of gestation. Sonographers were required to have more than 2 years of pelvic sonography experience including obstetric and gynecologic sonography. Specific research instruction on identifying and measuring uterine leiomyomata was provided for the sonographers. They were trained not to discuss any history of uterine leiomyomata with participants.

Uterine leiomyomata were defined by the Muram criteria (Muram et al., 1980) with the addition of including masses with a maximum diameter of 0.5 cm or greater. All leiomyomata were measured in three perpendicular planes. Sonographers repeated the measurement of each plane three times separated by measurements of the gestation to reduce the chance that focal contractions would be misclassified as leiomyomata. The three measurements in each plane were averaged to determine three leiomyoma diameters and a total leiomyoma volume was calculated using the ellipsoid formula. A mean leiomyoma diameter (the average of the three planes) was also calculated and used for size measurement.

Leiomyomata were drawn onto a uterine diagram based on appearance on ultrasound and were categorized by location (fundus, corpus, cervix) and position (anterior, posterior, right and left). Leiomyoma type was defined as submucous if distorting the uterine cavity without identifiable myometrium between the leiomyoma and the endometrium, subserous if distorting the external contour of the uterus, intramural if within the myometrium but not distorting the outer contour or cavity, and subserosal pedunculated if attached to the outside of the uterus with an identifiable stalk. Leiomyoma and fetal images were saved initially as print images. Later, digital images with both still and video clips were available for review by study investigators (S.K.L., K.E.H.).
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Statistical analysis

Time-to-pregnancy data are traditionally censored after a year because at that point many women may receive treatment. We censored time to pregnancy after 11 months because possible digit preference (simply reporting ‘1 year’ rather than the exact number of months) led to implausibly high probabilities of conception in the 12th cycle (2.8% of women reported conceiving in this cycle); however, we also censored following 12 months follow-up in sensitivity analyses. We estimated the effect of uterine leiomyomata on time to pregnancy with a discrete time hazard model, a discrete time analog of the continuous time Cox proportional hazard model. The discrete time hazard model estimated the conditional probability of pregnancy in each month as well as the effect of leiomyomata on time to pregnancy. Our first analysis examined whether the presence of one or more leiomyomata was associated with time to pregnancy, using the no-leiomyoma group as a reference category. Odds ratios (ORs) greater than one indicated a higher cycle-specific probability of pregnancy with relation to that predictor and therefore a decreased time to pregnancy, while ORs <1.0 indicated a decreased cycle-specific likelihood of pregnancy and a corresponding increased time to pregnancy.

We categorized average leiomyoma diameter (the average diameter of all leiomyomata in the uterus) and total leiomyoma volume (the volume of all leiomyomata in the uterus) into quartiles among women with one or more leiomyomata and estimated the effect of each quartile relative to the no-leiomyoma group. Finally, separate models estimated the effects of number of leiomyomata, type, location, and segment as predictors of time to pregnancy. Women without leiomyomata were used as the reference category in each analysis. We considered maternal age (<25, 25–<30, 30–<35 and 35+ years), race/ethnicity (White, non-Hispanic, Black, non-Hispanic, Hispanic, other), education (high school or less, some college, college), body mass index (underweight, normal, overweight, obese) and employment (unemployed versus employed) as potential confounders. All analyses were performed in R (www.r-project.org) and Stata.
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Results

Of the 3000 women, 89% had no leiomyomata and 11% had one or more leiomyomata (Table I). There were notable demographic differences between the groups: women with leiomyomata were more likely to be older, black, more educated, have a higher BMI and earlier age at menarche. The prevalence of leiomyomata among the women ineligible for this study was not significantly different from the prevalence of fibroids among eligible women.
Table I
Table I
Cohort demographics by presence of leiomyomata.

We compared leiomyoma characteristics by time to pregnancy (pregnant in the first 3 months or not) in Table II. The most common types of leiomyomata were intramural and subserous. In bivariate analyses, women with subserous and pedunculated leiomyomata were slightly more likely to report taking longer than 3 months to conceive. Women in the top two quartiles of mean leiomyoma diameter were slightly more likely to become pregnant in more than 3 months than women without leiomyomata. Number of leiomyomata and total leiomyoma volume had little impact on whether a woman became pregnant in the first 3 months or not.
Table II
Table II
Description of leiomyomata and leiomyoma characteristics among women who became pregnant before and after the mean time to pregnancy.

The 3000 women contributed 10 122 cycles. The median time to pregnancy was 2 cycles and 93% of women conceived within the first 11 cycles. Among women with leiomyomata, the median time to pregnancy was three cycles and among women without leiomyomata the median time to pregnancy was two cycles. We found very little evidence of increased time to pregnancy for presence of leiomyomata or for leiomyoma type, location, segment or numbers (Table III). There was also no significant association between time to pregnancy and average leiomyoma diameter or total leiomyoma volume. All ORs were between 0.6 and 1.1; no estimate was significant and most estimates were relatively precise. Additional analyses revealed little evidence of different effects of any leiomyoma characteristic by ethnic group (black versus white); however, these post hoc analyses were based on smaller sample sizes. Further analyses indicated no significant effect of particularly large leiomyomata (average diameter >50 mm; N= 50 women) relative to no leiomyomata (OR = 0.8, 95% confidence interval: 0.5–1.3). In sensitivity analyses, in which women were not censored after 12 months and the full time until pregnancy was used, there were no meaningful changes in our results.
Table III
Table III
Association between leiomyoma presence, type, location, segment, numbers, volume and time to pregnancy.
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Discussion

Although previous research has found an association between leiomyomata and fecundability (Farhi et al., 1995; Benson et al., 2001, Sheiner et al., 2004; Shokeir, 2005; Klatsky et al., 2008), we found no significant association between any leiomyoma characteristic and time to pregnancy in this retrospective time-to-pregnancy analysis of women who were able to conceive without medical intervention. The presence of leiomyomata did not alter the length of time to conception and women having two or more leiomyomata had the same cycle-specific odds of conception as women with no leiomyomata. The type of leiomyoma present also did not affect time to pregnancy. Leiomyoma location (anterior, posterior, both) did not affect the reported time to pregnancy, nor did the uterus segment (cervix, corpus, or fundus). Leiomyoma volume and leiomyoma diameter did not significantly change reported time to conception.

The effects of leiomyomata on time to pregnancy in our study may be underestimated because women who failed to conceive or were being treated for infertility were excluded, which may also impact the generalizability of our results. These exclusions, however, may not be sufficient to explain the difference in our findings compared with prior evidence showing improvement in fertility after myomectomy. Any condition affecting the ability of a woman to conceive would be expected to impact time to pregnancy. It would be unusual for leiomyomata to cause infertility requiring treatment but not an increase in time to pregnancy among women who conceive without treatment. One potential explanation for this difference is that women in this cohort are not comparable to women in previous studies. Previous studies that examined the relationship between leiomyomata and infertility have largely been conducted in specialty referral clinics, where characteristics of women may be systematically different from women in the general population of women of childbearing age. Our cohort is unique in that it consists of women who have not been treated for infertility, are younger and reflect a more diverse population base. Prior studies have mainly compared the effect of myomectomy among women who had been referred for fertility concerns, who might have tried other infertility treatments before undergoing leiomyoma removal, or might have more severe leiomyomata; so results would not be expected to be generalizable to this cohort or other women of childbearing age. In addition, we note that the median time to pregnancy observed in our study (two cycles) is similar to that seen in other studies examining time to pregnancy among women who eventually conceive (Gnoth et al., 2003; Baird and Wilcox, 1985; Whitworth et al., 2011).

Additionally, it is important to note that leiomyomata size and location were determined following conception. Changes in the leiomyomata size or location as a result of pregnancy could introduce bias into our estimates. This study lacks measures of the clinical symptoms of the tumors. However, leiomyomata characteristics have been shown to map poorly to symptoms, and, as a result imaging is a gold standard (Wegienka et al., 2003, 2004; Myers et al., 2011). We observed relatively few leiomyomata that would typically be categorized as large. Only 26 women had leiomyomata with an average diameter of >50 mm and only 5 women had more than 1 leiomyoma of >50 mm. Differences in fibroid characteristics such as these may partly explain the discrepancy between the results observed in clinical populations and our study. Finally, we lacked adequate sample size to examine the possible interactions between fibroid size, type or location and did not account for differences in cycle lengths.

Although several studies tend to suggest an association between leiomyomata and adverse outcomes like reduced fertility and miscarriage (Farhi et al., 1995; Ramzy et al., 1998; Bajekal and Li, 2000; Donnez and Jadoul, 2002; Olivera et al., 2004; Promislow et al., 2004, Sheiner et al., 2004; Narayan and Goswamy, 1994; Feinberg et al., 2006; Klatsky et al., 2008), our analysis showed no relationship between leiomyomata and reported time to pregnancy. Leiomyoma characteristics, like location or type, did not result in decreased fecundability, and there was no dose–response relationship between leiomyoma size, number, volume or location and time to pregnancy. This retrospective analysis provides reassurance to the majority of women in the general population (although perhaps not to those with numerous large leiomyomata) with leiomyomata who want to conceive.
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Authors’ roles

G.J. conducted the analysis and wrote the paper. R.M. supervised G.J., assisted with analysis, writing and hypothesis formation. D.B. assisted with writing, interpretation and study design. S.L. assisted with writing and interpretation. K.H. designed the study, assisted with the formation of the hypothesis, interpretation of the results, and writing and revisions.
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Funding

This research was supported in part (D.D.B. salary) by the National Institute of Environmental Health Sciences, NIH. The work was conducted as part of the Right from the Start study. The parent study received support from the American Water Works Association Research Foundation under contract no. 2579; National Institute of Child Health and Human Development Grants R01 HD043883-04 and HD049675: ‘Consequences and Course of Uterine Fibroids in Pregnancy’. Recruitment was also supported in part by Vanderbilt CTSA grant UL1 RR024975-01 from NCRR/NIH.
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Conflict of interest

None declared.
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Uterine leiomyomata and fecundability in the Right from the Start study

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High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence.[Am J Obstet Gynecol. 2003]
Prevalence of uterine leiomyomas in the first trimester of pregnancy: an ultrasound-screening study.[Obstet Gynecol. 2009]
Myomas of the uterus in pregnancy: ultrasonographic follow-up.[Am J Obstet Gynecol. 1980]
Effect of uterine leiomyomata on the results of in-vitro fertilization treatment.[Hum Reprod. 1995]
Outcome of pregnancies in women with uterine leiomyomas identified by sonography in the first trimester.[J Clin Ultrasound. 2001]
Obstetric characteristics and perinatal outcome of pregnancies with uterine leiomyomas.[J Reprod Med. 2004]

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Review Fibroids, infertility and pregnancy wastage.[Hum Reprod Update. 2000]
A prospective controlled study of the effect of intramural uterine fibroids on the outcome of assisted conception.[Hum Reprod. 2001]
Effect of corporal fibroids on outcome following embryo transfer in donor-oocyte recipients.[Clin Exp Obstet Gynecol. 2004]

Review Uterine factors in infertility--an overview.[Clin Obstet Gynecol. 1974]
Review Uterine fibroids: a clinical review.[Br J Obstet Gynaecol. 1990]
Review What are the implications of myomas on fertility? A need for a debate?[Hum Reprod. 2002]
Review Fibroids and reproductive outcomes: a systematic literature review from conception to delivery.[Am J Obstet Gynecol. 2008]

Recruitment for a community-based study of early pregnancy: the Right From The Start study.[Paediatr Perinat Epidemiol. 2004]

Myomas of the uterus in pregnancy: ultrasonographic follow-up.[Am J Obstet Gynecol. 1980]

Effect of uterine leiomyomata on the results of in-vitro fertilization treatment.[Hum Reprod. 1995]
Outcome of pregnancies in women with uterine leiomyomas identified by sonography in the first trimester.[J Clin Ultrasound. 2001]
Obstetric characteristics and perinatal outcome of pregnancies with uterine leiomyomas.[J Reprod Med. 2004]
Hysteroscopic management in submucous fibroids to improve fertility.[Arch Gynecol Obstet. 2005]
Review Fibroids and reproductive outcomes: a systematic literature review from conception to delivery.[Am J Obstet Gynecol. 2008]

Time to pregnancy: results of the German prospective study and impact on the management of infertility.[Hum Reprod. 2003]
Cigarette smoking associated with delayed conception.[JAMA. 1985]
Fecundability among women with type 1 and type 2 diabetes in the Norwegian Mother and Child Cohort Study.[Diabetologia. 2011]

Self-reported heavy bleeding associated with uterine leiomyomata.[Obstet Gynecol. 2003]
Uterine leiomyomata (fibroids): are bleeding symptoms more likely to be reported after diagnosis?[J Clin Epidemiol. 2004]
Self-report versus ultrasound measurement of uterine fibroid status.[J Womens Health (Larchmt). 2012]

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#14 User is offline   hukildaspida 

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Posted 18 June 2015 - 04:57 PM

Campaign Against Morcellation- Help Us Save Women's Lives

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#15 User is offline   hukildaspida 

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Posted 26 June 2015 - 03:03 PM

FBI Is Investigating Hysterectomy Device Found to Spread Uterine Cancer
The morcellator surgical tool was found to spread uterine cancer, and the FBI is examining what the largest maker of it, Johnson & Johnson, knew about the hazards

http://www.wsj.com/a...vice-1432746641

The FBI is investigating what Johnson & Johnson knew about hazards with its power morcellator surgical device. Above, the company’s headquarters in New Brunswick, N.J. Photo: Associated Press
By
Jennifer Levitz
May 27, 2015 1:10 p.m. ET
180 COMMENTS

The FBI is investigating a surgical device that was found to spread cancer in women, including looking into what the largest manufacturer of it, Johnson & Johnson, knew about the tool’s hazards before pulling it off the market last year, according to people who have been interviewed by the agency.


It is unclear what stage the inquiry is in. The Federal Bureau of Investigation’s Newark, N.J., office, which is overseeing the investigation according to the three people interviewed, declined to comment. A J&J spokesman said the New Jersey-based medical company isn’t aware of an investigation into the device, called a laparoscopic power morcellator.

Over the past several months, FBI agents have interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006; a doctor who went public after her own cancer was worsened by the tool in 2013; and a California woman who has collected names of close to 400 patients and families of patients who may have been harmed by the tool, these people said.

The probe comes after the U.S. Food and Drug Administration warned in November that morcellators shouldn’t be used on the vast majority of women.

Many hospitals and the nation’s largest health plans either have curtailed use of morcellators or are considering limits.

Previously used in tens of thousands of minimally invasive procedures a year, power morcellators cut up benign uterine growths known as fibroids so the tissue can be removed through tiny incisions. The device is mostly used in hysterectomies.

The FDA warned in April 2014 that women undergoing fibroid surgery have a 1 in 350 chance of harboring dangerous uterine sarcoma that can’t be reliably detected before the operation. Morcellators can spread the malignancy and worsen the outcome, the FDA said. In November, the FDA called for a “black-box” warning—its strongest caution—on the tool.

J&J withdrew the tools from the market last July. Devices from other morcellator manufacturers remain on sale.
A version of the power morcellator, suspected of spreading cancer in some women. ENLARGE
A version of the power morcellator, suspected of spreading cancer in some women. Photo: Dustin Chambers

Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa., said the FBI interviewed him on May 12 about his 2006 correspondence with the J&J subsidiary that sold morcellators.

Dr. Lamparter contacted the company’s Ethicon division after he began noticing more morcellated specimens in his lab, according to emails and letters reviewed by The Wall Street Journal. He wrote that he was concerned about several issues, including the potential for an undetected cancer to be inadvertently spread by the surgical instrument.

Dr. Lamparter wrote in a February 2006 email to David Robinson, then an Ethicon medical director, that even at his small hospital, which he said had done 292 hysterectomies the previous year, gynecologists found an unexpected malignancy at least once annually.

The Laparoscopic Power Morcellator Explained
ENLARGE
The Wall Street Journal

Fast Facts

Five Questions About FDA Warning (Nov. 24)
Short Answer: What to Know About Morcellators (Nov. 21)
Answers for Women With Fibroids (Aug. 19)

“If a morcellation is done, the patient’s survival is jeopardized,” Dr. Lamparter wrote. He didn’t identify a specific case of this happening.

J&J spokesman Matthew Johnson confirmed the 2006 correspondence with Dr. Lamparter and said the doctor’s concerns led the company to revise the instructions for use of the device.

The new language included a line saying that if cancer is present, use of the morcellator “may lead to dissemination of malignant tissue,” Dr. Robinson wrote Dr. Lamparter in April 2006.

The company’s instructions had already recommended that doctors who suspected or know of malignant tissue should use a “tissue extraction bag”—a bag used to pull tissue from the body—with the device.

Dr. Robinson, who is retired from Ethicon, couldn’t be reached for comment.

Ethicon morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue,” Mr. Johnson said in a statement to the Journal.

Mr. Johnson said the company is “continually assessing the totality of the available data and information—including peer-reviewed studies and scientific literature, as well as physician feedback—related to our products.”

Other people said their conversations with the FBI didn’t center on J&J or other manufacturers.

Amy Reed, a 42-year-old Pennsylvania anesthesiologist who has been vocal about her worsened cancer after she underwent a hysterectomy with a morcellator at a Boston hospital in 2013, said the FBI has interviewed her several times over the past few months about her case.

The hospital where she had the procedure has acknowledged it worsened Dr. Reed’s cancer and that the device had spread malignancy in another patient in 2012.

Sarah Robinson, a physician assistant in Los Altos, Calif., said she was contacted by the FBI about two months ago. Ms. Robinson, who testified at an FDA hearing on the morcellator, has collected a list of women and families of women who believe their cancer was worsened by the device. Ms. Robinson said she sent an FBI agent a list of 386 names, which includes herself, on April 3.

Write to Jennifer Levitz at [email protected]
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