The FDA has announced that it is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. The FDA is warning against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. The FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications.
About 50,0000 procedures using power morcellators are done each year. Power morcellation involves inserting a small electric device into the abdomen and slicing up tissue in order to remove it through a small incision. Far less invasive than traditional abdominal operations, the procedure has been used to remove fibroid tumors from the uterus, or to remove the uterus itself.
However, a growing number of researchers and clinicians have abandoned the procedure as evidence has shown that it can scatter cancerous cells throughout the body, making the disease more lethal and harder to treat than it would have been otherwise. Studies about the increased cancer risk led Johnson & Johnson to recall its laparoscopic power morcellators earlier this year.
According to the FDA, the updated device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed. The boxed warning informs health care providers and patients that:
Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
The two contraindications advise of the following:
Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous. The IIE guidance applies to currently marketed and new laparoscopic power morcellators for general and specific gynecological indications.
The FDA estimates that about 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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, according to the FDA.
There are other surgical treatment options available for women with symptomatic uterine fibroids. Traditional surgical hysterectomy and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision are among other options available.
Help for Patients Injured from Medical Device Complications
Products such as laparoscopic power morcellators are manufactured with the goal of helping to improve the health and quality of life for patients. The FDA and other regulatory agencies monitor the safety and effectiveness of surgical devices and other medical products to ensure that they are safe and effective. But despite these efforts, thousands of patients are seriously injured each year due to complications caused by improperly manufactured devices or other medical products.
At Heygood, Orr & Pearson, we believe that medical devices manufacturers that fail to make sure that their products follow basic health and safety standards should be held accountable in a court of law for the accidents and illnesses caused by their products. Our law firm believes that all patients should have the right to experienced and qualified legal counsel to ensure that their interests are represented and that their rights our protected.
The lawyers at Heygood, Orr & Pearson have resolved hundreds of claims involving defective medical products, dangerous drugs, and medical malpractice on the part of doctors or hospitals. Our attorneys have secured verdicts and settlements for our clients totaling more than $200 million.
If you or a loved one has been hurt by a defective surgical device or other medical product, you may be eligible to file a lawsuit and receive compensation. For a free legal consultation about your case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form on this site.