Virginia Beach Power Morcellator Lawyer
For many years women who underwent hysterectomies were treated with laparoscopic power morcellators. These surgical tools were recently revealed to be linked to the spread of an aggressive form of cancer and they are currently the subject of numerous lawsuits against manufacturers.
What Are Power Morcellators?
Gynecologists use power morcellators to perform procedures, such as hysterectomies or myomectomies in a surgical setting. The instruments are also called electric morcellators. They do much of the cutting involved in laparoscopic and robotic surgeries. The morcellators themselves are very small devices with rotating blades that break down large tissue masses into small fragments. The tissues that are broken down are then vacuumed away and out of the body.
The technique allows surgeons to make incisions of less than 2 centimeters in size and be able to remove fibroids and other tissue. These smaller entry points to the body mean doctors do not have to make large cuts through core stomach muscles, allowing less invasive surgery. The transition to the small incisions has led to quicker patient recoveries, less post-operative pain and fewer wound complications but appears to come with a price.
What Are Power Morcellators Used For?
Doctors perform about 600,000 hysterectomies on women every year in the United States. Nearly half of those procedures, which involve the removal of the uterus, are minimally invasive. Surgeons have been using tissue morcellation in a growing percentage of those surgeries. As many as 12 percent of hysterectomies involve the use of morcellators.
2 Removing Uterine Fibroids
Uterine fibroids are benign and occur in as many as 80 percent of women by the time they reach 50. They are the most common cause of an enlarged uterus. These non-cancerous tumors account for about 40 percent of all hysterectomy cases, making it the most common reason for a woman to have the procedure. There are other factors that result in an enlarged uterus including adenomyosis, another form of non-cancerous growths that can cause the uterine walls to thicken, and uterine or cervical cancer.
Warnings over Power Morcellators
In April 2014, the Food and Drug Administration (FDA) warned the laparoscopic power morcellator was responsible for the spread of a potentially deadly and aggressive form of cancer in thousands of women who had used it.
Women who have uterine fibroids receive routine screening for various forms of uterine cancer before undergoing these surgeries to reduce the risk of spreading cancer throughout the body via power morcellators. Although doctors can diagnose most forms of cancer pre operation, a rare form, called leiomyosarcoma or uterine sarcoma, can mimic the appearance of benign uterine fibroids in medical imaging and it’s often undetectable in preoperative testing. The FDA estimates 1 in 352 women who undergo a hysterectomy or a myomectomy is found to have an undetected uterine sarcoma.
It’s only after surgery that this aggressive cancer can be discovered by a pathologist. Alarmingly, if a power morcellator was used to extract the tissue, the hidden cancer could have spread, turning into metastatic leiomyosarcoma, which worsens a patient’s likelihood of long-term survival. The rate of five-year survival drops from 50 percent to just 4 to 16 percent.
The Recall from the Manufacturers
Johnson & Johnson, the largest manufacturer of power morcellators through its Ethicon subsidiary, has called for doctors worldwide to stop using laparoscopic power morcellators and return the devices due to the risk of spreading undiagnosed uterine sarcomas and other tissue found throughout a patient’s body.
Several large hospitals including Cleveland Clinic and Brigham and Women’s Hospital in Boston, have suspended morcellator procedures in light of the FDA advisory and some health insurers have placed restrictions on coverage for morcellation procedures.
Lawsuits over Power Morcellators
Johnson & Johnson may have known about the serious risks associated with power morcellators well before the FDA’s warning, providing a basis for lawsuits. In 2006, a full eight years before the medical devices were withdrawn, Dr. Robert Lamparter, then a pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania, wrote to the company imploring them to “reconsider the risk of the devices, stating they “may lead to dissemination of malignant tissue” during the removal of the uterus or uterine fibroids, as prescreening for cancer before the procedure is not always effective.
The email correspondence between the doctor and Ethicon, indicated that the Johnson & Johnson subsidiary company failed to treat the warning seriously enough. It merely included a precaution in the labeling for their morcellators’ instructions for use, but neglected to act further at the time. Ethicon later dismissed Lamparter’s complaint in a May 10, 2006 letter.
If a power morcellator spread a virulent form of cancer, the effect on your health would likely have been very serious. Patients who develop advanced stage, metastatic cancer or parasitic fibroids after undergoing power morcellation may be able to recoup a wide range of costs including medical expenses and the cost of surgery and chemotherapy. The physical and mental pain and suffering associated with further treatments can have a significant impact on a patient’s quality of life and the loss of a loved one, can be grounds for a wrongful death lawsuit.
In March 2014, a man whose wife died filed a hysterectomy cancer lawsuit in the U.S. District Court, Eastern District of Pennsylvania. His 53-year-old wife died from uterine cancer less than a year after undergoing hysterectomy that used power morcellation to treat bleeding from her uterus in March 2012. Another case has been filed in the U.S. District Court for the District of New York by a woman who was diagnosed with cancer after having robot-assisted hysterectomy that used power morcellation. We can expect to see many more of these cases in coming years.
What To Do If You Have Been Hurt
Our dangerous devices injury lawyers have helped many people who have been hurt by deadly medical devices and surgical procedures. We will provide you with experienced representation and make sure your claim is properly handled among the others in the mass tort litigation. Time may be short to make your claim.