How does a patient know he or she is a victim of a defective medical device? Many people simply do not know the answer, especially if it’s a device that is probably not mentioned any of the discussions you may have had with your surgeon prior to a laparoscopic operation.
The Bryant Law Center is investigating the use of one device – a power morcellator – in area hospitals and surgical suites offering robotic and laparoscopic surgeries for women and men. The Food and Drug Administration in 2014 issued a stark warning. “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.”
The US Food and Drug Administration grew so concerned about the use of this device used in hysterectomies and fibroid tumor removal that one manufacturer removed its model from the market and strong advisories have been issued for the use of other brands.
Non-cancerous uterine fibroid tumors can occur in as many as three fourths of all women by age 50. It can cause an enlarged uterus also is a leading cause of hysterectomies. It is estimated that about half of the 600,000 hysterectomies a year use minimally invasive robotic procedures.
The power morcellator was used extensively in laparoscopic and robotic gynecologic surgery for 20 years. Simply started, it is a device that resembles an electric drill with a set of small rotating blades on the end of a shaft. What it essentially does is to “mince” or morcellate a fibroid tumor. The advantage was that surgeons were able to remove tumors and perform operations with only a small skin incision for entry.
They were first approved in about 1993 and five firms marketed the devices. But reports of post operative complications began to get notice. Studies show that when the rotary knives “minced” a malignant tumor, not all of the fragments were recovered, leading to a condition known as disease “dissemination.” That, some physicians claim, allowed cancers to “seed” throughout the uterine or abdominal cavity. One such study found that this “seeding” or dissemination occurred in nearly two-thirds of all of the surgeries in which it was used.
The FDA in April and later in November of 2014 cautioned against the use of power morcellators in uterine surgeries and warned they could spread bits of fibroid tumor.
This is the exact warning the FDA issued:
“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.”
- 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.
Who is at risk? Women who have had or need pelvic laproscopic surgery. If you or a loved one underwent laparoscopic or robotic surgery to remove fibroid tumors or undergo a hysterectomy, and had complications, including subsequent reports of cancer, contact attorney Emily Roark at the Bryant Law Center to receive a confidential evaluation of your legal rights. Contact Emily at 270-442-1422.