Morcellator Cancer Risk
WARNING: POWER MORCELLATOR SURGERY CAN RESULT IN ADVANCED STAGE CANCER
In wide use in gynecologic surgeries since first approved in 1995, laparoscopic power morcellators have the potential to cause significant and irreversible harm. Specifically, the use of power morcellators in uterine surgeries can spread unsuspected cancer cells throughout the patient’s abdomen. When this happens, a relatively treatable disease is transformed into a late-stage and often deadly cancer.
Johnson & Johnson has been criticized for failing to investigate or warn the public of the morcellator cancer risk. The risk of morcellator cancer has been the subject of recent FDA warnings, statements issued by gynecological groups, and campaigns launched by individual doctors. Since 1995, millions of women have undergone surgery with no knowledge of the morcellator cancer risk.
Filing a morcellator cancer lawsuit may be the best recourse consumers have to push for corporate accountability for the injustices done to women who have developed late-stage cancer as a result of power morcellator surgery. This page contains comprehensive information about power morcellator devices and surgical applications, the findings on morcellator cancer risks, and FDA morcellator cancer warnings.
Understanding Morcellator Surgery and the Ovarian Cancer Connection
Laparoscopic power morcellators (LPMs) are medical devices used in a variety of surgeries. The particular devices that have been recalled by Johnson & Johnson are used for gynecologic surgeries including hysterectomy (removal of the uterus) and myomectomy (removal of fibroids in the uterus) as a means to treat uterine fibroids. Morcellator surgery is offered as a minimally-invasive surgery option, and promises shorter recovery periods and hospital stays. However, experts say the threat of morcellator cancer outweighs the potential benefits of the treatment.
Uterine fibroids are common in menstruating women. Some have no side effects; others can cause heavy and prolonged menstrual bleeding, pelvic pain, and the need for frequent urination. There are a range of treatments for uterine fibroids: traditional open surgery for hysterectomy or myomectomy, laparoscopic surgery without morcellation, laparoscopic power morcellator surgery, blocking of the uterine artery, intensive ultrasound, and drug therapy. Hysterectomy is the most common non-pregnancy surgery performed on women in the United States, and morcellator surgery has become a widespread method of hysterectomy.
Morcellators use long, tube-shaped blades to cut ovarian tissue into miniscule pieces which are removed via vacuum through tiny incisions. When compared to open surgery, these devices allow surgeons to avoid making large incisions. By fragmenting the tissue inside the body, morcellators enable surgeons to remove uterine fibroids or the entire uterus gradually.
Surgeons now understand that through the process of mincing and removing ovarian tissues, unsuspected cancer cells are effectively seeded throughout a woman’s abdomen. This transforms a treatable cancer into a widespread, late-stage disease that is often fatal. Because there is no reliable means to detect uterine cancer prior to surgery, all women subject to this surgical method are potentially in danger of morcellator cancer. Approximately 1 in 350 hysterectomy patients has undetected uterine cancer.
LMS is a particularly aggressive form of uterine cancer. There is no reliable way to screen for LMS prior to surgery. The use of a power morcellator when LMS is present has devastating results for patients. Women who are diagnosed with LMS uterine cancer have a poor prognosis in general: only 40% are alive five years from their diagnosis. The use of morcellators further worsens their chances of survival.
Power morcellators are used in approximately 50,000-100,000 gynecologic surgeries each year. Several companies manufacture gynecologic morcellators, but Johnson & Johnson’s Ethicon division dominates the market.
FDA Morcellator Cancer Warning
Laparoscopic power morcellators were first approved as a Class II medical device by the FDA for gynecologic applications in 1995 based on their proven success at removing tissues. The device’s warning label did not include a caution regarding undetected or unsuspected uterine cancers.
In April of 2014, an FDA Safety Communication on the topic of morcellator cancer was released. In this warning, the FDA advised against the use of power morcellator devices for gynecologic laparoscopic surgeries due to the perceived likelihood of cancer spread. According to fda.gov, “FDA analysis revealed probability of risk was higher than previously appreciated” for morcellator cancer. Furthermore, the FDA stated, “current device designs do not mitigate [the] risk” for “dissemination of malignant tissue”.
In July of 2014, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to further evaluate the risk of morcellator cancer. Through a review of literature and adverse events reporting, the committee concluded that the spreading of cancerous cells and intensification of the disease occurs in 25-64% of cases where the patient has undetected cancer. Given that there is no reliable method to screen patient pre-operatively for uterine cancer, the risks posed by morcellation is severe.
Morcellation can spread cancer cells throughout the abdomen, “worsening a patient’s prognosis and likelihood for long-term survival”, according to the FDA morcellator cancer warning. Patients who undergo morcellation are less likely to be disease free (and less likely to survive) than those who underwent a different method of surgery. Due to the likelihood of spreading and intensifying unsuspected cancer, the FDA now warns surgeons against the use of morcellators for gynecologic surgeries including hysterectomy:If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
Doctors Warn of Morcellator Cancer Risk
Dr. Hooman Noorchashm, a Harvard doctor who has launched a campaign against the use of morcellators for hysterectomy, says that “power morcellation is so common that few doctors even mention it to patients”. Noorchashm asserts that using morcellators for hysterectomy is “a shameful act of professional negligence” because the devices can spread and intensify existing cancer. Because there is no reliable way to know if cancer cells are present prior to surgery, Dr. Noorchashm called for a widespread ban on the practice. Hooman’s campaign to raise awareness about morcellator cancer is a personal and professional mission; his wife developed late-stage ovarian cancer following a routine hysterectomy. The FDA morcellator cancer warning and subsequent recall came shortly after Dr. Noorchashm’s petition was launched.
Dr. Bobie Gostout, the chairwoman of Obstetrics and Gynecology at the Mayo Clinic, agrees that women should be given a fair warning about the dangers of morcellation cancer. Interviewed for a Wall Street Journal article, Dr. Gostout asserted that women should be given alternatives and choices because morcellation is “a questionable practice”.
Numerous medical groups and major hospitals have also taken a stand against this procedure due to the morcellator cancer connection, including Brigham & Women’s Hospital and Mass General. Cautioning against the practice, the Society of Gynecologic Oncology states, “morcellation… [has] the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity.” Patients have not been routinely warned of this danger so were unaware of the risk posed by morcellator cancer.
Morcellator Cancer Lawyers Help Women and their Families
Our attorneys handling morcellator cancer lawsuits on behalf of women and their family members who were diagnosed with ovarian cancer after having surgery are medical device litigation experts. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or your mother, spouse, or other loved one developed ovarian cancer after surgery, a morcellator cancer attorney can help by answering your questions and giving you a sense of your legal options.
Morcellator Cancer Lawsuits
Women who were diagnosed with ovarian cancer following a hysterectomy or myomectomy may have grounds for a morcellator cancer lawsuit. We provide legal representation for morecellator lawsuits on contingency basis, meaning that we charge no fee unless we win compensation on your behalf.