Morcellation has long been a controversial procedure because it is believed to spread undiagnosed cancer.
Many women, when diagnosed with painful or debilitating fibroid tumors, are usually given two options. These include removing the uterine fibroids in a surgical procedure where the doctor makes a large abdominal incision, or a minimally invasive laparoscopic procedure. Usually, the major surgery produces significant downtime, often taking 6 to 8 weeks to recover fully. Alternatively, the laparoscopic procedure involves treating the tumor through abdominal incisions no larger than two millimeters.
Leiomyomas, or uterine fibroids, are a significant burden to the health of a woman. In fact, nearly every woman will develop these benign tumors at some point in her life, usually when 45 years or older. While some fibroids have no symptoms at all, others produce abdominal discomfort and pain, excessive or abnormal bleeding and/or significant pressure in the pelvis region.
Some forms of infertility are caused by uterine fibroids, and are the most common reasons women undergo a hysterectomy procedure.
A Fateful Decision
For some women, undergoing a myomectomy or hysterectomy procedure that uses a morcellator is a fateful decision. This small handheld rotating blade device grinds uterine fibroids into tiny fragments that can be vacuumed or suctioned out through small abdominal incisions.
However, women with undiagnosed cancer cells within the uterine fibroids are at significant risk. This is because tragedy complications arise when the loose cancerous tissue spreads throughout the abdomen and into the pelvis during the procedure.
Why Morcellation Is Popular
Doctors often advise against traditional myomectomy and hysterectomy surgeries because of the increased risk of infection. As a result, in recent years, morcellator devices have maintain their status as a popular alternative to undergoing full abdominal incisions that often generate more pain, bigger scars, much longer recovery time and significant blood loss.
When dozens of cases involving advanced stages of cancer resulting from morcellation-associated procedures were filed with the Food & Drug Administration, a hearing was called by the agency. Gynecologists, medical health care providers, patients and surviving family members provided testimony. The outcome of the hearing determined that patients and doctors should be warned about the negative downside to using the product, with its possible reclassification.
The FDA Issued Warning
In April 2014, the Food & Drug Administration advisory board issued a warning to doctors and patients concerning the fatal effects to laparoscopic power morcellation use, involving myomectomy and hysterectomy procedures. Many hospitals and medical facilities have now banned the procedure while the future of morcellation is being investigated.
A Significant Risk
In an effort to determine the potential risk to women, the hearing held by the FDA involved numerous published studies including one from JAMA (Journal of American Medical Association). It concluded that while many researchers believe the risk of morcellation devices spreading cancer ranks low at one woman in 10,000, the JAMA study actually places the risk of hidden sarcomas at approximately 1 and 386 women that have undergone a myomectomy or hysterectomy.
Doctors and other medical researchers at Columbia University conducted the study, by gathering information from insurance databases. More than 36,000 patients undergoing hysterectomies using power morcellation devices were identified in the study, from information gathered at 500 hospitals in the United States, over six months.
Out of the 36,000 patients, 99 were unexpectedly diagnosed after the procedure with uterine cancer. An additional 26 women were diagnosed with other gynecological malignancies and 39 patients suffered abnormal uterine tumors. Endometrial hyperplasia was also detected in 368 women after the procedure.
Hard to Detect Cancer
Unfortunately, even with access to CT scans, MRIs and biopsies, doctors often struggle to detect hidden sarcomas, especially leiomyosarcoma, a deadly, but rare, cancer. In many incidences, the women’s doctors did not properly inform them about any risk of spreading cancer involved when performing the laparoscopic treatment.
This is because some doctors see the significant benefits of laparoscopic hysterectomy and myomectomy using a morcellator device, in women with limited options. Members of the Society of Gynecologic Oncology (SGO) received a letter from the organization claiming “morcellation has benefited hundreds of thousands of women.”
In addition, the organization believes that morcellation is especially beneficial for the majority of obese women, where abdominal (laparotomy) surgery would likely increase mortality and morbidity. It is the SGO organization’s belief that denying laparoscopic surgery using morcellation devices would be a disservice to many patients.
Over the last two decades, since morcellation devices were invented, manufactured and sold, many women have suffered and died prematurely due to associated risks from using the morcellator. The device has devastated surviving family members as well. Common statistics involved with myomectomy and hysterectomy procedures include:
- At least 600,000 women have a hysterectomy every year in the United States
- Thirty three percent of American women have had a hysterectomy by 70 years of age
- Nine out of every ten hysterectomy surgeries/procedures are performed to treat benign fibroids
- A great number of these procedures involvement only invasive techniques
- Morcellator devices are used to cut fibroid tumors into tiny pieces
- Due to inadequate testing prior to a hysterectomy, most fibroid cancers are never detected or identified
- Physicians often forgo testing for cancer before a hysterectomy or myomectomy
- Morcellator hidden cancer can easily spread the disease in the woman’s abdomen and pelvis areas
“Upstaging” occurs when the previously undetected cancer spreads from its original location in the uterine fibroid to other areas in the body. When this happens, other factors come into play, which include:
- Generally, the lifespan of a woman experiencing accidental morcellation of cancer (sarcoma) is usually shortened to 24 to 36 months
- The average survival rate of women at spreading stage IV leiomyosarcoma is five years
- Patients suffering sarcoma due to morcellation are 400 percent more likely to die from the cancer compared to women who are not treated using a morcellator.
With a minimal effort by the treating physician, and a recall of all morcellator devices in the medical marketplace, the spread of leiomyosarcoma and other sarcomas could be an avoidable catastrophe.
Slow to Respond
Johnson & Johnson, and other medical device manufacturers, have been slow to respond to problems associated with their morcellation devices. After the issued warning by the FDA in April 2014, Johnson & Johnson finally pulled their assortment of morcellation devices from the market, halting sales and asking hospitals to return the devices to the company. Unfortunately, for many patients, the actions by these medical device manufacturers came much too late.
New technology is already providing a safe alternative to power morcellation techniques. One of these includes enclosed morcellation, where a bag is wrapped around the treated tissue during the process of being ground up.
Doctors, health organizations, medical device manufacturers and the medical industry has long recognized that minimally invasive surgery reduces the chance of infection and minimizes recovery time. Unfortunately, when medical device manufacturers are quick to bring their products to market, they rarely provide adequate testing and clinical trials to minimize potential risks involved.
Fortunately, the FDA has finally concluded that procedures using power morcellation continues to pose a great potential risk to patients suffering from uterine fibroids. It remains essential to doctors discuss all available options to women that require a myomectomy or hysterectomy so an informed decision can be made on how to proceed.
Many lawsuits are being filed because of the high number of women who have suffered and/or died from the spread of leiomyosarcoma due to procedures using morcellation. Even though their quality of life is often diminished, these patient and surviving family members are seeking financial compensation for their pain, suffering and loss.