- Robert Califf MDCommissioner, Food and Drug Administration
- Peter LurieAssociate FDA Commissioner on Policy and Planning
- Lamar AlexanderUnited States Senator (R-TN), Chair Senate HELP committee
- Patty MurrayUnited States Senator, Ranking member Senate HELP committee
- Larry C. Gilstrap III, M.D.Executive Director, American Board of Obstetrics and Gynecology
- Bob Casey Jr.United States Senator, member of Senate HELP committee
- Jeff Shuren MDDirector, FDA Center for Devices and Radiological Health
- Sybill Storz, Managing DirectorKarl Storz GmbH & Co
- Hal LawrenceExecutive VP and CEO, American Congress of Obstetricians and Gynecologists
- William Maisel MDChief Scientist, FDA's Center for Devices and Radiological Health
- Barack ObamaPresident, United States of America
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.
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, by the Food and Drug Administration, revealed that 1 in 350 women who go for fibroid surgery actually have sarcoma. This means that everyday 2-5 women in the US – and more around the world are susceptible to having a deadly cancer spread because of morcellation.
This catastrophic problem has happened in my family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 350 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. This is a totally AVOIDABLE practice. People need to understand their options, which include hysterectomy through a mini-lapartomy incision or trans-vaginally – but – up until recently, most women never heard anything about morcellation or about the possibility of cancer upstaging. And, if they do, this risk is down-playe by most minimaly invasive gynecologists. We can tell you based on our experience, when cancers are spread by morcellation, the outcomes can be devastating - because the cancer is upstaged. We need your help.
Please sign our petition so we can get the word out. We want the American College 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).
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.
- Commissioner, Food and Drug Administration
Robert Califf MD
- Associate FDA Commissioner on Policy and Planning
- United States Senator (R-TN), Chair Senate HELP committee
- United States Senator, Ranking member Senate HELP committee
- Executive Director, American Board of Obstetrics and Gynecology
Larry C. Gilstrap III, M.D.
- United States Senator, member of Senate HELP committee
Bob Casey Jr.
- Director, FDA Center for Devices and Radiological Health
Jeff Shuren MD
- Karl Storz GmbH & Co
Sybill Storz, Managing Director
- Executive VP and CEO, American Congress of Obstetricians and Gynecologists
- Chief Scientist, FDA's Center for Devices and Radiological Health
William Maisel MD
- President, United States of America
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.
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