The case of Dr. Amy J. Reid has helped bring world-wide attention to the risks that power morcellation procedures can spread cancer inside a woman’s body. Dr. Reid, a 41 year old radiologist and mother of six children, had a power morcellation procedure to remove uterine fibroids. She was later diagnosed with an agressive cancer known as leiomyosarcoma (LMS) and is Stage 4. Dr. Reid and her physician husband, Hooman Noorchashm, M.D., believe that Dr. Reid’s LMS resulted from a hidden sarcoma that was cut up by the morcellation procedure and sprayed throughout her abdomen.
Dr. Noorchashm’s Petition to Stop Morcellators along with much other information about the risks posed by power morcellators is posted at Change.org. According to the Petition:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman (sic) 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.
Dr. Noorchasm’s Petition states that “Women should be told the truth and the practice should stop.” There are alternatives to power morcellation which do not result in tissue being chopped up and sprayed throughout the inside of the woman’s body. They include a minimally invasive vaginal procedure, a new procedure called “closed morcellation,” (which entails enclosing the device’s blades in a disposable bag which traps the spray), and an open procedure. In apparent response to the campaign initiated by Noorchasm, hospitals,( including Brigham and Women’s Hospital in Boston where Dr. Reid underwent her procedure), are discontinuing the use of morcellators; some insurers are refusing to pay for the procedure, the FDA issued a safety alert, and Ethicon, a division of Johnson & Johnson, issued a voluntary recall of its power morcellation devices.
The response from the German company that Dr. Noorchasm alleges manufactured the power morcellator used in Amy Reid’s surgery has been quit different. As reported in The Cancer Letter , Karl Storz, which manufactures the Rotocut Morcellator, is threatening to sue Dr. Noorchasm.
The “cease and desist letter” from Karl Storz to Dr. Noorchasm was re[produced in the 8/27/14 edition of The Cancer Letter as follows:
Dear Dr. Noorchashm,
This refers to several emails which you addressed—amongst others—to Dr. h.c. mult. Sybill Storz, the CEO of the KARL STORZ Group.
In your emails, you requested Dr. Storz to “recall your Rotocut morcellator device from the market”, arguing that it caused harm to patients. You also urged Dr. Storz that she “must do right by all those who have been harmed’’ (21 May 2014) and you sent her (and other recipients) a collage of “30 women, some dead’; calling them “Your victims. Victims of your standard of care and using your robotic a power morcellator DEVICES”. Again, in this email (24 June 2014) you imply that the POWER MORCELLATOR was the cause of some women’s deaths.
We know that amongst the 30 women displayed on the mentioned collage, is your wife. We also totally appreciate the shock and the suffering that you both must have had when the unsuspected uterine leiomyosarcoma was diagnosed on her after a laparoscopic treatment withPOWER MORCELLATION. In spite of this, and with a full understanding of your concern that POWER MORCELLATION may potentially aggravate the cancerous status of a patient with hidden uterine sarcoma, one must distinguish between cause and effect. One thing is clear: Uterine sarcoma is not caused by power morcellation! To stop all morcellation today will not decrease the number of women carrying hidden, lethal uterine sarcomas. Women who happen to have the misfortune of a hidden uterine sarcoma are and have been seriously illbefore LAPAROSCOPIC SURGERY is or was applied to them. The illness has other causes and is by no means the result of a dangerous or malfunctioning device.
Furthermore, the risk of spreading an undetected cancer by minimal invasive surgery (MIS) must be measured against the benefits and risks of ubiquitous open surgery. The latter is generally associated with higher rates of morbidity and mortality.
MIS has many recognized advantages over open surgery such as: Reduced hemorrhaging (less need for blood transfusions), smaller incisions (reducing pain and RECOVERY time, as well as post-operative scarring), reducing exposure of internal organs to possible external contaminants (thereby lowering the risk of acquiring infections), less pain, less post-operation medication and shorter hospital stay needed (often same day discharge), overall a faster return to everyday living. On the other end of the scale, there is the unquantified—but generally considered to be low—risk of inadvertently disseminating unsuspected malignant tissue in the body.
This may potentially result in the “upstaging” of a tumor and a worsening of a patient’s prognosis. But, again, as clearly came out during the recent FDA Obstetrics and Gynecology Devices Panel Hearing, held on 10th and 11th July 2014, it is not the (long tested) morcellator device that causes this problem, but the inability of today’s diagnostic medicine to detect, without invasive surgery, aggressive uterine sarcomas and to distinguish them from benign uterine fibroids.
You are assured that KARL STORZ will monitor the situation closely and will do its best to protect patients against any unnecessary risks. But, at the present stage, and considering the weak data on the specific risks attributable to the morcellation device itself (as opposed to the procedure), KARL STORZ considers it best to wait for the FDA’s final conclusions and recommendations and decided not to take a product from the market which, for hundreds and thousands of women, offers a safe and less invasive way for treating fibroids than by open surgery.
Based on the above, KARL STORZ insists that you immediately stop your campaign against the Rotocut morcellator, any other morcellator DEVICE of KARL STORZ, and that you stop defaming the device and/or the KARL STORZ management in the medical world or on the market place. We will no longer tolerate unfounded and unproven allegations such as the ones contained in your previous emails and we will hold you responsible.
Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s or any other women’s UTERINE CANCER, and/or any aggravation of their cancerous situations, we would not hesitate to take appropriate legal actions to protect our good name and our rights.
We trust that you understand our position and conclude by wishing you and your wife that you win the battle against the shocking illness which, nevertheless, cannot be attributed to any of our devices or acts.
After threatening to sue Dr. Noorchasm, the letter concludes “by wishing you and your wife that you win the battle against this shocking illness which, nevertheless, cannot be attributed to any of our devices or acts.” How touching!