In April 2014, the FDA (Food & Drug Administration) issued a warning to doctors, hospitals, medical device manufacturers and patients of the increased potential of cancer after a hysterectomy. The warning claims that a surgical morcellation device, typically used to perform hysterectomies, can potentially spread cancer throughout a woman’s pelvis and abdomen. The Journal of American Medical Association (JAMA) reinforces the claim by the FDA that using the laparoscopic power morcellation device is risky.
The FDA is advising surgeons to stop performing any hysterectomy procedure that uses morcellators, a small medical device that grinds fibroid tissue in a woman’s uterus. It was the conclusion of the agency that the medical device has been proven to spread previously undiagnosed cancerous tissue throughout the abdomen and pelvis, worsening the odds of survival in any woman with uterine cancer.
In addition, Columbia University issued a study stating that one woman in 368 who has undergone hysterectomy have undetected uterine cancer. The study indicates that the potential risk of spreading that cancer is significantly heightened by using the morcellation device.
Leiomyosarcoma and Other Uterine Cancers
Leiomyosarcoma (LMS) is rare, deadly cancerous tissue that grows in smooth muscle cells of the uterus and abdomen. This aggressive soft tissue cancer can develop malignant tumors from mesenchymal cells. This highly resistant sarcoma does not usually respond well to radiation or chemotherapy. The best outcome when the cancer is detected will usually occur from surgical removal.
The primary cause of the development of leiomyosarcoma is still not known. However, many researchers believe that environmental risk factors and genetics play a key role in its development. Radiotherapy and other high-dose radiation exposure have also been connected to the development of leiomyosarcoma, as does exposure to a variety of chemical herbicides.
Unfortunately, medical morcellator devices seem to exacerbate the growth of leiomyosarcoma and other uterine cancers when used in a hysterectomy procedure. This deadly disease can spread in various stages. While it usually metastasizes when in stage IV, it can easily metastasize to other areas at any stage when the morcellator device grinds the tissue and spreads it inside the woman’s abdomen and pelvis.
The healthcare company Johnson & Johnson, along with other medical device manufacturers, have designed and manufactured morcellators since the mid-1990s. The tiny narrow device is equipped with spinning blades. When inserted into a woman’s abdomen through a tiny incision, the morcellators slices or grinds tissue and vacuums the fragments out. While this procedure has many benefits including quick recovery time and a lower risk of infection, it has an increased potential of spreading undetected cancer.
A large group of gynecologists is disputing the data released by the FDA, downplaying the danger of the device. As a result, a two-day hearing in early July was held by the agency to evaluate the product, and make a decision to either ban or restrict morcellators use for hysterectomies and myomectomies (uterine fibroid removal).
Research involved in the study claims that the minimally invasive laparoscopic hysterectomy procedure presents the potential risk of spreading a variety of uterine sarcoma. These cancers include leiomyosarcoma, considered a very rare disease, along with endometrial cancer, which tends to be more common, especially in older women.
Unfortunately, fibroid uterine sarcomas are difficult to detect. These types of cancer can easily masquerade in the body as a benign fibroid, making it challenging to diagnose and properly treat. While some gynecologists perform a battery of tests before the laparoscopic hysterectomy, searching for endometrial cancer, it is often difficult to find. Endometrial cancer often starts in the uterus lining and few women experience outward symptoms.
Data collected since the start of morcellation device use in the 1990s suggests that the potential risk of having undiagnosed uterine cancer is rare – possibly one in 10,000 cases. However, newly released studies indicate that those numbers were extremely low. Figures that are more accurate are closer to one woman in 386, a surprisingly unexpected higher number and substantially greater risk.
Morcellation Device Proponents
Not everyone in the medical community is in agreement with the findings of the FDA. Proponents of the medical morcellator argue that the device provides many benefits. Gynecologists and surgeons claim that without availability of a morcellator device, many patients will require a traditional abdominal hysterectomy, which often produces more complications, challenging recovery and bigger scars.
Of the more than 500,000 hysterectomies performed in the United States every year, less than half involve minimally invasive procedures. The total number of hysterectomies every year involving morcellation techniques is only 16 percent.
Counseling the Patient
Many patients are unaware that laparoscopic hysterectomy using a morcellation device poses a significant risk to spreading cancer. Without proper counseling, and a complete discussion about all the available options including performing a traditional hysterectomy, the patient often does not have enough information to make an informed decision.
Morcellation Device Recalls
Even though there is extensive data showing the high potential risks involved in morcellators spreading cancer, many medical device manufacturers have been slow to recall their products. Only recently has the leading morcellator device manufacturer Johnson & Johnson pulled their morcellation products from the salable market, and asked customers to return existing units to the company.
As of July 2014, Johnson & Johnson has recalled three of its power morcellator models, including:
- Morcellex Sigma
- Gynecare X-Tract
In addition, other morcellator manufacturers are considering a voluntary recall of their products. Some of these power morcellator manufacturers include:
- Blue Endo – MOREsolution
- Nouvag – Morzellator
- Ethicon of FemRX (Johnson & Johnson) – Diva
- Lumenis, Ltd. – VersaCut
- LiNA – Xcise
- Karl Storz – KSC Steiner Morcellator, ROTOcut and SuperCutMorcellator
- Cook Urological – Cook tissue morcellator
- Smith & Nephew – TrueClearMorcellation System
- Olympus – VarioCarveMorcellator and PKS PlasmaSORD
- Richard Wolf – Morce Power Plus
The FDA is strongly urging gynecologists and surgeons to avoid the use of power morcellators during hysterectomies due to the direct link with spreading cancer. This is because even with ultrasounds, CT scans, MRIs and biopsies, doctors are usually unable to detect leiomyosarcoma and other serious uterine cancers before the hysterectomy procedure.
The FDA is urging women needing a hysterectomy to consider other available options to avoid the potential risks involved in cancer spreading from morcellation.
The number of cases involving women suffering leiomyosarcoma and other uterine cancers diagnosed after a minimally invasive laparoscopic hysterectomy using morcellation is high. Because of that, product liability and medical malpractice attorneys are reviewing cases to obtain financial compensation for women suffering damages.
Lawsuits are being filed for women that have suffered uterine sarcoma and other cancers after having a procedure including:
- Laparoscopic Supracervical Hysterectomy
- Removal of Uterine Fibroids (Laparoscopic Myomectomy)
- Robotic Hysterectomy Involving Morcellation
Many of these women were never informed how this type of hysterectomy procedure has increased risk of spreading undetected cancer. Attorneys are filing lawsuits on their behalf because the medical community and minimally invasive surgical device manufacturers have known of the potential risks involved for decades.
Any woman that suspects that her newly diagnosed cancer developed after her hysterectomy should consider speaking to a competent medical malpractice/product liability attorney if her procedure involved morcellation. A successful lawsuit will hold all responsible parties accountable for their negligent actions and provide financial recompense to the patient.
In some cases, surviving family members are filing morcellation wrongful death lawsuits for financial recompense after losing a loved one to deadly uterine cancer. Most medical malpractice and product liability attorneys review and evaluate cases using a contingency fee agreement, where no out-of-pocket expenses are required.
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