Since 2013, lawsuits have been filed across the country by patients and the families of deceased patients who were diagnosed with a rare but aggressive and deadly form of cancer. This cancer was detected after use of a common surgical instrument in laparoscopic procedures.
What is a morcellator?
A morcellator is a surgical instrument, first introduced in 1993, that is used to remove large masses of tissues. During laparoscopic surgery, a morcellator is used to grind up the mass into smaller pieces that can then be withdrawn. Initially, morcellators where used for uterine extraction, but they have been expanded and can be used for the removal of any organ.
In laparoscopic hysterectomies, a morcellator is used to break down the uterus so that it can be removed, piece by piece, through small incisions in a woman’s abdomen. It is used in approximately 13% of the 600,000 hysterectomies performed annually. Morcellation is also a common practice in the removal of benign tumors called fibroids. One of the reasons for its popularity is the fact that it is minimally invasive. Incisions for insertion and extraction are small which can shorten the patient’s hospital stay as well as her recovery time. The minimal invasion also helps decrease the risk of infection and later complications.
Despite the fact that morcellators have been in use for more than 20 years, there is still limited understanding of both the short-term and long-term complications which may arise from the use of this instrument in surgeries. Because morcellators are cylindrical tools with sharp, cutting jaws at one end, doctors have voiced concerns about the potential danger of injury to surrounding organs such as the bladder, spleen, pancreas and bowel. More concern, however, has been raised by the very real danger of disseminating cancer.
How do morcellators cause cancer?
The greatest concern raised and the source of many current lawsuits involves the dissemination of leiomyosarcoma (LMS). LMS are tumors that can grow in the smooth muscle connective tissue in the uterus, stomach or walls of blood vessels. LMS can also hide within fibroids. When morcellators mince large masses that contain LMS, the cells can travel beyond the site of the original tumor through the bloodstream to other areas of the body. This is called seeding.
While LMS is rare, its effects are devastating. It is an unusually aggressive and unpredictable form of cancer. It can lay dormant for long periods of time before recurring. It is estimated that 70% of patients who have undergone treatment suffer a recurrence within eight to sixteen months. Because it is generally not responsive to chemotherapy or radiation, a patient’s best hope is surgical removal while the tumor is still small and in its original position (non-metastatic). Even in this case, the five year survival rate is only 50%. Unfortunately, there is no reliable way to test for LMS in the uterus or fibroids prior to morcellation. After the cells are disseminated, they spread through the body quickly (metastatic) and the cancer can go from stage I to stage IV in a relatively short period of time. The five year survival rate for metastatic LMS is between 4% and 16%.
The first lawsuits against the manufacturers of morcellators were filed in 2013. In these suits, plaintiffs who were diagnosed with stage IV cancer or whose loved ones had died as a result of disseminated cancers cells released by the power morcellators, argued that the patients were never warned of the risk of seeding and that the risk of LMS in particular was not adequately represented.
In fact, in December 2013, doctors in Boston drafted a paper for the New England Journal of Medicine seeking a moratorium on the use of morcellators. In the paper, the doctors concluded that more women than previously thought had undetected cancer in their fibroids. The conclusion suggested that the 1 in 1,000 estimate of women contracting uterine cancer as a result of morcellation in an earlier procedure was closer to 1 in 400.
Furthermore, a study published a year earlier by doctors from Brigham and Women’s Hospital determined the risk of contracting LMS following morcellation was approximately 1 in 1,000, not the 1 in 10,000 figure often quoted to patients.
Patients also argued that the three main morcellator manufacturers – Blue Endo, Lina Medical and Ethicon, Inc. (a division of Johnson & Johnson) – ignored health factors that put some women and a higher risk. Those factors included women being menopausal and their uterine fibroids being very large.
In April 2014, the Food and Drug Administration (FDA) issued a safety alert discouraging the use of morcellators in uterine procedures. Hospitals nationwide have also taken steps to mitigate damages by limiting use of this procedure and doing more to inform women of the risks. Following the FDA’s alert, Johnson & Johnson suspended sale of its morcellator product and ultimately pulled the product from the market completely until such time as the potential danger of the morcellators could be examined more fully. This is significant as Ethicon, Inc. was once the largest seller of morcellators, capturing nearly three-quarters of the market before the recall.
Remedial measures that have been taken since the connection between morcellators and LMS do little for those already harmed by those instruments. Manufacturers knew or should have known the unreasonably high risks of using morcellators for hysterectomies and fibroid removal. Those who have been injured or whose loved ones have lost their lives as a result do have legal options, can be compensated for their losses and should consult an attorney.