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As concerns continue to mount about the risk of uterine cancer following a hysterectomy with morcellation, one the leading manufacturers of these controversial devices appears to be trying to silence an out-spoken critic who is calling for their power morcellators to be removed from the market.
Dr. Hooman Noorchashm and his wife, Dr. Amy Reed, have been leading the charge to raise awareness about the cancer risk associated with power morcellators used in recent years during minimally invasive laparoscopic hysterectomy and myomectomy procedures for removal of uterine fibroids.
The couple started an on-line petition at change.org calling for power morcellator recalls, indicating that “many women have died unnecessarily because dangerous cancers of the uterus and ovaries are being spread using morcellators.” As of this week, the petition now has over 80,000 supporters.
Dr. Reed was diagnosed with leiomyosarcoma after undering laparoscopic surgery involving the use of a Karl Storz Rotocut morcellator, which is a medical device that allows the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small laparoscopic incision. However, for women with unsuspected sarcoma contained within the uterus or ovaries, morcellation may cause the spread of cancer cells throughout the body, quickly upstaging the contained cancer.
The German medical device manufacturer Karl Storz recently sent a letter to Dr. Noorschashm, warning that they would pursue legal action against him if he continued to implicate their Rotocut power morcellators in his wife’s cancer or call the device unsafe. The letter was published by The Cancer Letter on August 27, claiming that Dr. Noorschashm is “defaming the device and/or the Karl Storz management”.
Karl Storz indicates that if it learns of any other statements from Dr. Noorschashm indicating that their power morcellators were responsible for his wife’s cancer, or that of any other woman, the company will not hesitate to take legal actions against him.
FDA, Other Companies, Echo Couple’s Concerns
The threats come amid increasing concerns among consumers and within the medical community over the link between power morcellators and uterine cancer.
Largely in response to the efforts of Drs. Noorschashm and Reed, the FDA launched an investigation earlier this year and urged doctors to avoid using power morcellators during laparoscopic hysterectomy or uterine fibroid removal surgery.
The federal regulatory agency indicated that the risk of spreading cancer with the devices is not justified, since an estimated one in 350 women undergoing the procedures may have unsuspected sarcoma, which doctors are unable to reliably diagnose prior to the surgery.
At an FDA advisory meeting this summer, two panels of experts agreed that there appeared to be no safe way to user power morcellators for uterine fibroid removal, but couldn’t decided if the devices should be completely banned or just carry the most stringent warning labels possible. They also urged doctors to tell women the potential cancer risks involved in using the devices.
Johnson & Johnson’s Ethicon subsidiary, which controlled more than 70% of the morcellator market, agreed that the devices were unsafe, and determined that there is no way current technology can make them safe, and issued a power morcellator recall, announcing it was leaving the morcellator market entirely.
While others have called on Karl Storz to do the same, the German medical device manufacturer indicates in the letter to Dr. Noorchashm that it has decided not to remove their product from the market at this time, calling the data on specific risks attributable to the morcellation device itself weak.
“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,” wrote the manufacturer in the letter. “We will no longer tolerate unfounded and unproven allegations such as the ones contained in your previous emails and we will hold you responsible.”
In multiple media reports, Dr. Noorchashm has indicated that he is not concerned about the Karl Storz threat and that he will continue his campaign.
Laparoscopic Morcellator Cancer Lawsuits
As women and families throughout the United States learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or myomectomy may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the devices as safe as they could have been.
A number of hysterectomy morcellation lawsuits are now being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers spread following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.
In cases filed against Karl Storz, Ethicon and other manufacturers, plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous.
In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.