• Petitioning Barack Obama

This petition will be delivered to:

President of the United States
Barack Obama
President, American Congress of Obstetricians and Gynecologists
Jeanne Conry
Executive VP and CEO, American Congress of Obstetricians and Gynecologists
Hal Lawrence
Ethicon, Inc.
Casey M. Tansey, Chief Executive Officer
Karl Storz GmbH & Co
Sybill Storz, Managing Director
Richard Wolf Medical Instrumentation Company
Chief Executive Officer or President
President and CEO, Intuitive Surgical
Gary S. Guthart Ph.D.
Executive Director, American Board of Obstetrics and Gynecology
Larry C. Gilstrap III, M.D.
Commissioner, United States Food and Drug Administration
Margaret Hamburg MD
United States Senator from Massachusetts
Elizabeth Warren
Associate FDA Commissioner on Policy and Planning
Peter Lurie

Health Alert: Many Women Have Died Unnecessarily Because Dangerous Cancers of the Uterus and Ovaries Are Being Spread using MORCELLATORS. Stop MORCELLATION in Minimally Invasive Gynecological Surgery.

    1. Hooman Noorchashm
    2. Petition by

      Hooman Noorchashm

      Philadelphia, PA

Friends of the Public,

Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.

More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques.  Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator.  However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer.  Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well.  Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.  

This is called ‘up staging’ the cancer. 

It is important to understand:

1) The average life span following accidental morcellation of sarcoma is only 24-36 months.

2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.

3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated. 

This is an avoidable disaster.

This problem has been recognized for more than two decades.  A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma.  This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.

This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation.  A chance of 1 in 415 for such a devastating outcome is much too high to accept.  Women should be told the truth and the practice should stop.

Please help us bring an end to spreading cancer with morcellation.  There are alternatives.  Some surgeons have begun using a special bag to avoid spreading cancer cells.  Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness.  Other people opt for a traditional open hysterectomy.  People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.

Please sign our petition so we can get the word out.  We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.

For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).

The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8

The following companies manufacture and distribute uterine morcellator devices:

1) ETHICON: Gynecare morcellator

2) Storz: Rotocut Morcellator

3) Richard Wolf Medical Instrumentation Company

4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator

5) Blue Endo MOREsolution Tissue Morcellator

Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).

 https://www.youtube.com/watch?v=f6luiX6UQmg

 Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.

To:
Barack Obama, President of the United States
Jeanne Conry, President, American Congress of Obstetricians and Gynecologists
Hal Lawrence, Executive VP and CEO, American Congress of Obstetricians and Gynecologists
Casey M. Tansey, Chief Executive Officer, Ethicon, Inc.
Sybill Storz, Managing Director, Karl Storz GmbH & Co
Chief Executive Officer or President, Richard Wolf Medical Instrumentation Company
Gary S. Guthart Ph.D., President and CEO, Intuitive Surgical
Larry C. Gilstrap III, M.D., Executive Director, American Board of Obstetrics and Gynecology
Margaret Hamburg MD, Commissioner, United States Food and Drug Administration
Elizabeth Warren, United States Senator from Massachusetts
Peter Lurie, Associate FDA Commissioner on Policy and Planning
Place an immediate moratorium on intracorporeal uterine morcellation during minimally invasive hysterectomy, on all gynecological tissue morcellation devices and any devices used to morcellate the uterus intracorporeally in the United States and Abroad. It is your high duty to first, do no harm.

Sincerely,
[Your name]

Recent signatures

    News

    1. Journal of the National Cancer Institute, October 2014

      Hooman Noorchashm
      Petition Organizer

      From the October 2014 issue of the Journal of the National Cancer Institute:
      http://jnci.oxfordjournals.org/content/106/10/dju339.full

      FDA Considers Restricting or Banning Laparoscopic Morcellation

      The U.S. Food and Drug Administration is considering restricting or banning morcellation in minimally invasive hysterectomies and myomectomies (removal of fibroids) because of new reports of higher incidence of undiagnosed sarcoma in women undergoing these procedures. Research now links morcellation to the spread, or upstaging, of undetectable gynecological cancers.

    2. An interview with Canada's CBC radio program, "The Current"

      Hooman Noorchashm
      Petition Organizer

      Please listen to our interview with Health reporter Alison Motluk with care. This interview aired on Canada's CBC radio program "The Current" on 10/15/14:

      http://www.cbc.ca/thecurrent/episode/2014/10/15/health-canada-warns-surgery-using-a-morcellator-could-spread-undetected-cancer/

      Health Canada warns surgery using a morcellator could spread undetected cancer, Amy Reed & her husband are fighting to stop the practice

      Not long ago, only surgeons and their patients would have heard of a morcellator. But now lawyers have become involved in a big way, following efforts to declare the devices dangerous.

    3. A Children's Book by Dr. Amy Reed

      Hooman Noorchashm
      Petition Organizer

      Naughty Children

      ~ A R Josephson (author) More about this product
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      You Save: $0.30 (5%)
      Naughty Children

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    4. The Bucks County Courier Times, 10/9/14

      Hooman Noorchashm
      Petition Organizer
      Lower Makefield native's battle with cancer fuels benefit run

      Reed, who earned her medical degrees from the University of Pennsylvania, said the 2013 surgery was performed to end bleeding from what was thought to be a benign fibroid tumor on her uterus. The surgeons used a morcellator to pull the uterus through an incision in Reed's belly button.

    5. The "Slay Sarcoma" 5K Walk/Run, 10/11/14

      Hooman Noorchashm
      Petition Organizer

      Dear Friends,
      Please join us for Amy's "Slay Sarcoma" 5K Walk/Run in Bucks County, PA this coming Saturday.

      This event is organized in support of the Leiomyosarcoma research and our campaign demanding an FDA ban on power morcellators in gynecological surgery.

      Please join us and meet the hundreds of supporters who will be at Tyler State Park in support of Amy, LMS research and the campaign to ban power morcellators.

      http://www.eventbrite.com/e/slay-sarcoma-5k-runwalk-registration-11130239847?aff=eorg

      Slay Sarcoma 5K Run/Walk

      Lace up your sneakers and join us in fighting leiomyosarcoma, a rare and aggressive sarcoma. Sponsored by the Leiomyosarcoma Direct Research Foundation (LMSdr). All proceeds go towards funding sarcoma research. Registration includes the 5K run/walk and kids fun run as well as a free t-shirt.

    6. OpEd in the Philadelphia Inquirer

      Hooman Noorchashm
      Petition Organizer

      Please demand that the FDA's Center for Devices and Radiological Health correct itself in order to ensure patient safety. Please read the following OpEd:
      http://www.philly.com/philly/opinion/inquirer/20140926_Put_safety_at_forefront_for_patients.html

    7. From the Philadelphia Inquirer, 9/30/14

      Hooman Noorchashm
      Petition Organizer

      The FDA's Center for Devices and Radiological Health is failing to protect and promote public health. Medical devices are too loosely regulated to ensure patient safety. The cost of this FDA defect is to many American lives and to our health insurance infrastructure. The morcellator disaster likely being but one example of FDA's incapacity at ensuring medical device safety in the face of industry desire to innovate fast. Please read this Philadelphia Inquirer article with care:

      http://www.philly.com/philly/news/nation_world/20140930_Two_more_studies_say_the_FDA_is_lousy_at_regulating_medical_devices.html

      Two more studies say FDA bad at regulating medical devices

      Last updated: Tuesday, September 30, 2014, 1:08 AM Posted: Monday, September 29, 2014, 4:46 PM Two new studies add to a mountain of evidence that the U.S. Food and Drug Administration has done a poor job of making sure medical devices are safe.

    8. Please read and sign the petition from Ms. Sarah Robinson

      Hooman Noorchashm
      Petition Organizer
      Sign the petition: Campaign against Morcellation,- Help Save Women's Lives

      I just signed a petition to The United States House of Representatives, The United States Senate, and President Barack Obama: 1. Ban the faulty Power Morcellator , a surgical device, that spreads a deadly hidden cancer masquerading as a common fibroid. 2.

    9. The Philadelphia Inquirer, 9/26/2014

      Hooman Noorchashm
      Petition Organizer
      Put safety at forefront for patients

      Posted: Friday, September 26, 2014, 1:08 AM By Hooman Noorchashm In July, the Food and Drug Administration called for an advisory panel to assess the risks involved in a routine gynecological practice known as morcellation, which is used in women with symptomatic fibroid tumors of the uterus.

    10. Dr. Oz Show on Morcellation

      Hooman Noorchashm
      Petition Organizer
      Morcellators Could Spread Hidden Cancer

      Dr. Oz discusses how this device, which is used to remove fibroids in hysterectomies, could spread undiagnosed cancer cells in your body.

    11. From the Wall Street Journal, 9/22/14

      Hooman Noorchashm
      Petition Organizer
      Gynecologists Resist FDA Over Popular Surgical Tool

      Doctors nationwide are still using a gynecological tool months after the U.S. Food and Drug Administration warned that it can spread undetected cancer, demonstrating the limits of the regulator's reach into clinical practice. Since the FDA warning in April, Johnson & Johnson pulled the device called a laparoscopic power morcellator from the market; many hospitals, such as Boston's Brigham and Women's Hospital and Philadelphia's...

    12. A Letter to Dr. William Maisel, 9/20/14

      Hooman Noorchashm
      Petition Organizer

      Dr. Maisel,
      This email is to demand your immediate and unconditional resignation as the deputy director and chief scientist at FDA's Center for Devices and Radiological Health (CDRH).
      I regret having to write this public letter as a concerned citizen, a surgeon and a patient advocate whose family was directly affected by a clear lack of FDA intervention in a public health hazard. I am left with no choice but to inform the public of your ethical conflict of interest as a CDRH leader of the FDA's device section - and its relationship to the morcellator disaster.
      As it pertains to the deadly hazard of gynecological morcellators in the United States and abroad, your primary stated mission as a strong industry advocate represents a clear conflict of ethical interest in guaranteeing patient safety. Under your leadership, the CDRH has failed to call for a ban on power morcellators, nearly two months after the data was clearly delineated and the victims presented at the FDA advisory - nearly one year after we raised an alarm from Boston, MA.
      It is now our understanding that the FDA may be delaying a final statement. This delay in a ban on power morcellators by the FDA is occurring despite the overwhelming evidence of deadly hazard. And many industry advocates appear to have been assured that FDA will not be banning the power morcellators from market.
      The group of victims and advocates are increasingly clear that this lethargy in FDA action to protect the public is directly related to industry lobby to which you, as a CDRH leader, have clearly stated your loyalty in the press:
      http://www.medscape.com/viewarticle/824087
      http://www.currentmedicine.tv/2014/06/11/fda-official-william-maisel-guilty-of-soliciting-prostitution-keeps-his-job/
      Dr. Maisel, it is time for you to do right by all those women harmed, resign from the CDRH and relinquish the responsibility to protect the public's health to those of your colleagues at FDA with capacity and patient safety foremost in their highest priority.
      We await news of your resignation as a leader of the CDRH, in the interest of keeping the FDA's mission to ensure public health clean and devoid of industry influence.
      Dr. Maisel, your resignation is not a request. It is a direct demand as a gravely concerned citizen and representative of the many families harmed by FDA/CDRH inaction under your leadership.
      We await your response,
      HN.
      --
      Hooman Noorchashm MD, PhD

    13. Meet Dr. William Maisel, Director of FDA's medical devices section

      Hooman Noorchashm
      Petition Organizer

      Who is in charge of the morcellator review at FDA? And why has the device not been banned yet? Please read:

      http://www.currentmedicine.tv/2014/06/11/fda-official-william-maisel-guilty-of-soliciting-prostitution-keeps-his-job/

      CurrentMedicine.tv " FDA official, William Maisel, pleads guilty to crime, keeps job

      April 24, 2013 By Steven E. Greer, MD In July of 2012, the New York Times reported on an FDA scandal of the agency spying on internal whistleblowers, by hacking into their work and personal emails. The FDA employees who were the victims filed lawsuits, and The Healthcare Channel interviewed the plaintiff's lawyer, Stephen Kohn.

    14. Another Blue Cross Company Drops Morcellation

      Hooman Noorchashm
      Petition Organizer
      Capital BlueCross stops paying for surgical procedure - Pittsburgh Business Times

      Harrisburg-based Capital BlueCross will no longer pay for gynecologic procedures involving a controversial surgical tool, the company announced. The ban becomes effective Nov. 1 for operations using a device called a power morcellator. The tool is used in minimally invasive procedures to remove the uterus or uterine fibroids.

    15. Letter from a Concerned Citizen and Surgeon, 9/12/14

      Hooman Noorchashm
      Petition Organizer
      40-34 Guest Editorial - The Cancer Letter Publications

      Learning from the Power Morcellation Fiasco: Federal Government Must Do More to Regulate DevicesBy Hooman Noorchashm Following our discovery that my wife’s occult uterine cancer was morcellated using a gynecological power morcellator, we initiated a vigorous campaign to protect others from this avoidable harm.

    16. Reached 75,000 signatures
    17. Corporate Ethics at Its Height. Read With Care

      Hooman Noorchashm
      Petition Organizer
      Special Report - Device Maker Threatens Legal Action Against Doctor Who Launched Campaign to End Power Morcellation - The Cancer Letter Publications

      SPECIAL REPORT - Aug. 27, 2014 Device Maker Threatens Legal Action Against Doctor Who Launched Campaign to End Power Morcellation By Paul Goldberg and Matthew Bin Han Ong A German company that makes devices now under FDA scrutiny for their potential to spread sarcoma threatened legal action against the U.S.

    18. Meet Dr. Andrew Brill: FDA advisor and OB/Gyn

      Hooman Noorchashm
      Petition Organizer
      J&J Paid Over $150K to Doctor Who Sat on FDA Safety Panels

      Dr. Andrew Brill recently stepped down from a Food & Drug Administration safety panel due to a serious conflict of interest. Womens Surgery Group NEW BRUNSWICK, NJ-Disclosures on the website of Johnson & Johnson's (J&J) Ethicon subsidiary reveal that Dr. Andrew I.

    19. Meet Ms. Nidra Philips

      Hooman Noorchashm
      Petition Organizer
      If You're a Black Woman Considering Fibroid Surgery, You Must Read This

      Every year the equivalent of an airplaneful of women wind up dying when their minimally invasive surgery to remove fibroids or their uterus accidentally spreads undiagnosed uterine cancer. Many of those women are black, yet few of them fully understand the risks.

    20. Senators Schumer and Gillibrand demand an All-out Morcellator recall

      Hooman Noorchashm
      Petition Organizer

      United States Senators Schumer and Gilibrand have demanded all morcellators to be recalled from the marketplace. Please read:
      http://online.wsj.com/articles/senators-want-more-companies-to-pull-surgical-device-from-market-1408405349#livefyre-comment

      Senators want more companies to pull power morcellators from market.

      Two U.S. senators are urging the Food and Drug Administration to ask manufacturers of a common surgical tool called a power morcellator pull their devices from the market because of a risk of spreading undetected uterine cancer in women, a spokeswomen for one of the senators said Monday.

    21. Please Join for a 5K Run/Walk to Defeat Sarcoma

      Hooman Noorchashm
      Petition Organizer

      Please register and join us in support of Leiomyosarcoma Research:
      http://www.eventbrite.com/e/slay-sarcoma-5k-runwalk-registration-11130239847?aff=efbevent

      Slay Sarcoma 5K Run/Walk

      Lace up your sneakers and join us in fighting leiomyosarcoma, a rare and aggressive sarcoma. Sponsored by the Leiomyosarcoma Direct Research Foundation (LMSdr). All proceeds go towards funding sarcoma research. Registration includes the 5K run/walk and kids fun run as well as a free t-shirt.

    22. Reached 50,000 signatures

    Supporters

    Reasons for signing

    • Yvonne Thomas CINCINNATI, OH
      • 39 minutes ago

      Because a friend of mine had this done and is in a bad way as a result. Why would anyone want this type surgery? It's barbaric!

      REPORT THIS COMMENT:
    • Mary Ellen McNulty MENTOR, OH
      • about 4 hours ago

      I had the power morcellator used in my hysterectomy at the Cleveland Clinic, only to find out later that I had ovarian cancer. I was not informed that this technique was being used on me.

      REPORT THIS COMMENT:
    • Lesley Kinney NORTH KINGSTOWN, RI
      • about 7 hours ago

      This is a crazy thing to do. I've had a hysterectomy and I had never heard of morcellation!

      REPORT THIS COMMENT:
    • Dianne Knowles BOSTON, MA
      • about 16 hours ago

      We have to stop the madness and hold doctors accountable.

      REPORT THIS COMMENT:
    • Judith Pomeroy NORTH RIDGEVILLE, OH
      • 1 day ago

      Fortunately I had a wonderful surgeon who did an open hysterectomy and I'm fine. This is new to me but I strongly support this petition. I wish this couple the best.

      REPORT THIS COMMENT:

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