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Many hospital networks in the United States have suspended minimally invasive uterine fibroids surgeries involving medical power morcellator devices, awaiting guidance from the FDA (Food & Drug Administration). The decision of hospitals to suspend uterine morcellator procedures is not surprising due to new evidence recently released.
In April 2014, the FDA issued a safe communication stating there is a direct connection of morcellator-involved myomectomies and hysterectomies with cancer. This connection poses a greater risk to women than initially believed. Recent studies claim that the number of cases involving previously undetected cancer spreading after a uterine fibroid procedure using morcellators is far greater than first reported.
Uterine leiomyomas (fibroids) tend to be a common tumor in about one third of all women, especially those 45 years of age and older. Most leiomyomas are managed expectantly, without any noticeable symptoms.
However, some fibroids cause significant problems including pelvic pain, heavy uterine bleeding, pressure and sensitivity in the pelvis, and in some cases, infertility. Women with these conditions typically have the problem resolved through a uterine fibroid removal procedure (myomectomy), or by a partial or total hysterectomy. In the U.S., treating symptomatic uterine fibroids through these procedures is common.
Beginning in the mid-1990s, numerous medical device manufacturers developed morcellators to expedite fibroid removal. Morcellators are small devices with rotating blades that cut up or grind dense uterine fibroids. The tiny fragments can then be vacuumed out in a small tube through the abdomen. This minimally invasive laparoscopic surgery requires only two small incisions, offering significant advantages over traditional procedures, including:
- Avoidance of making a sizable abdominal laparotomy incision
- Quicker healing from surgery
- Diminished postoperative pain
- Reduced risks of infection at the surgical site
- Easier recovery, allowing the patient to resume full activities much faster
Gynecologists often recommend laparoscopic surgery using open power morcellation to patients with a fibroid-laden uterus. This method removes masses of tissue through a tiny laparoscopic incision.
Unfortunately, open power morcellation techniques to remove fibroid tissue have a crucial consequence. This method can spread tiny tissue fragments throughout the peritoneal cavity. When these fragments contain cancer cells, the growth of tissue nodules postoperatively can happen unexpectedly and, in some cases, quickly.
Unfortunately, scientists have yet to devise accurate testing to properly diagnose uterine sarcoma before the procedure is performed. Proper testing could identify patients who are not prime candidates for a myomectomy or hysterectomy involving a power morcellator. Alternatively, no risk is present when surgeons remove the uterus or fibroid tumor intact, as happens in a traditional hysterectomy or myomectomy.
A Previously Known Problem
Since almost the beginning of using morcellator devices, the medical community has known about the potential risks involved in spreading undiagnosed cancer when using morcellators on the uterus.
When this problem became apparent, many hospital network systems chose to strengthen their informed consent for women having the procedure as a way to warn patients of the potential spreading risk of undetectable cancer. However, the FDA is claiming that the magnitude of risk is significantly higher than what was first believed by the medical community.
The recent safety alert issued by the U.S. FDA claims that one woman out of 368 having a minimally invasive myomectomy or hysterectomy, using power morcellators, is at risk of upstaging previously undiagnosed cancer. This means those cancer cells, which may or may not have presented a problem as the woman aged, pose a significant risk of being spread throughout her abdomen as a part of the procedure that is difficult to control.
The FDA asserts that when surgeons perform open power morcellation on women with cancer, the risks of the procedure spreading cancerous tissue is high. Because of the increased cancer risk, the FDA discourages using power morcellation devices for removing uterine fibroids or the uterus.
Morcellator Manufacturers Respond
In the days following the issuance of the FDA safety alert in April 2014, on the dangers involved in morcellator devices, the Johnson & Johnson healthcare company suspended sales of its power morcellators. While not recalling the device, Johnson & Johnson, the leading provider of power morcellators, stated the company is merely suspending the distribution and promotion of it surgical devices while it awaits feedback from the medical community.
By July 2014, Johnson & Johnson finally recalled its power morcellators. This response was likely prompted from the intensive study published by JAMA (Journal of American Medical Association). The company announced it would start asking surgeons to pull the power morcellators from use and return them to the company. It is also considering reaching out to hospitals, medical facilities and other customers who have purchased the morcellation devices in a worldwide withdrawal to remove any remaining for sale in the medical marketplace.
The Ethicon unit of Johnson & Johnson, makers of the controversial device, is said it is recalling its power morcellators due to the uncertainty of using the device for myomectomies and hysterectomies.
The number of women who have undergone laparoscopic hysterectomy or myomectomy and suffered upstaging of leiomyosarcoma averages one in 368 procedures. Women suffering stage 4, the final stage, of leiomyosarcoma have an 85 percent mortality rate within five years. Leiomyosarcoma is a rare, deadly form of uterine cancer that metastasizes to the bladder, pelvis, lungs and other areas.
Making the Decision
Unfortunately, many women are never given the variety of options available for treating uterine fibroids. Doctors often insist on performing a laparoscopic myomectomy or hysterectomy for various reasons including:
- Shorter hospital stay (lower cost to insurance companies)
- Faster healing
- Reduced rate of infections
- Reduced pain
- Smaller scars
While the benefits to laparoscopic surgery are high, doctors have no reliable method for determining if the fibroids are cancerous before the removal procedure. It is imperative to perform a benefit-risk analysis with the doctor to determine which methods of treating the uterine fibroid is best, before making the final decision on the procedure.
Safer Treatment Options
Well over a half million hysterectomies are performed each year in the United States to tackle a variety of problems including fibroids and uterine cancer. Only about one in every seven procedures involves morcellators. This is because there are numerous other options available that do not require use of the device.
It is important to note that the FDA discourages using a laparoscopic power morcellator to perform a myomectomy or hysterectomy. Other procedures are available, without the potential risk of spreading undiagnosed cancer hidden in the fibroid tumor. These include:
- Uterine Artery Embolization – The physician uses a catheter to block the artery of the uterus
- Surgical myomectomy or hysterectomy through the abdomen or vagina
- High-intensity ultrasound
- Laparoscopic hysterectomy or myomectomy that does not use the morcellator
- A variety of drug therapies
Taking Legal Steps
For years, doctors have used safer alternatives for treating uterine fibroids. Because doctors, hospitals and medical device manufacturers have known about the risks associated with morcellator spreading cancer, many women have taken legal steps to protect their rights.
Women suffering advanced leiomyosarcoma cancer as a result of a myomectomy or hysterectomy procedure using power morcellation devices are filing cancer lawsuits.
Product liability attorneys are investigating the defective design and methods of using power morcellators.
Financial recompense is likely available to any woman diagnosed with uterine cancer, including leiomyosarcoma, following uterine fibroid removal surgery or a hysterectomy involving morcellation. In addition, many surviving family members are filing wrongful death suits after losing a loved one to spreading uterine cancer caused by a morcellator device.