The FDA warns that a deadly cancer called metastatic leiomyosarcoma may be spread by a surgical device called a power morcellator during minimally invasive surgeries for women.
Growing concerns among medical professionals and the FDA about the saftey of surgical procedures using power morcellators have led some manufacturers, including Johnson and Johnson, to stop selling their devices. Patients, diagnosed with cancer post-surgery, have also expressed worry. They fear their cancer was caused by use of a power morcellator and have taken legal action against the device makers.
Power Morcellators are used in minimally invasive hysterectomies and myomectomies and can help reduce recovery time for patients. They are also used in certain liver, kidney and spleen surgeries. They are used to break up non-cancerous tumors called fibroids. Power morcellators use a rotating blade to cut tissue, and the spinning blade can spread undected cancer cells into the abdominal cavity and surrounding tissue.
One of the most dangerous forms of cancer that can develop from use of a power morcellator in women is a type of uterine cancer called metastatic leiomyosarcoma.
In april of 2014 the FDA, in response to reports of metastatic leiomyosarcoma developing in patients after having surgery involving laparoscopic power morcellation, issued a safety alert. The alert warns about and discourages the use power morcellators for myomectomies and hysterectomies.
Use of the tool during routine surgical procedures puts patients at increased risk for developing cancer from the spread of previsouly undetected cancer cells.
Power morcellation is a technique used in minimally invasive laparoscopic myomectomy and hysterectomy procedures. Surgeons perform minimally invasive laparoscopic surgeries by making only a few small incisions. Using a power morcellator, an electric medical device that uses rotating blades to breakup tissue, is an alternative to using a scalpel or scissors. The fragmented tissue is removed through the small incisions.
Because they use a rotary cutting action, power morcellatos can spread parts of fibroid tissue thoughout the abdomen and pelvic. The tissue fragments are thrown about by centrifugal force from the devices spinning blades. Fibroid tissue fragments can attach themselves to other tissue and organs causing new fibroids to grow. The consequences if the resulting fibroids are benign are pain, infection, and bowel obstruction. In many cases the cells spread are malignant cancer cells. These cells go undetected at the time of surgery and can have much more dier consequences.
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What Causes Uterine Cancer
Uterine cancer is the fourth most common cancer among women in the United States. It is caused by cells that grow abnormally and muliply rapidly causing tumors. The overwhelming majority of uterine cancers affect the endometrium, the lining of the uterus. With a five-year survival rate of more than 80 percent, endometrial is one of the more curable cancers. Sarcomas, tumors of the outer muscular lining, make up the other 5 percent of uterine cancers and are much harder to treat.
While exact causes can only be guessed at, a number of risk factors including high levels of estrogen in the body, being over age 40, obesity, and a family history of the disease have been indentified as increasing a woman’s chance of developing uterine cancer. Certain medications including hormone replacement therapy and some breast cancer treatments may also increase the risk of uterine cancer.
Leiomyosarcoma (Uterine Cancer)
Occuring primarily in women 40 to 60 years of age, uterine leiomyosarcoma is a soft-tissue sarcoma that develops from smooth muscle cells.
A rare and aggressive form of cancer, only 1 percent of patients with uterine cancer have uterine leiomyosarcoma. These tumors have a high rate of residivism. Almost 70 percent of patients that undergo treatment—which consists of surgery to remove the tumor—seeing tumors return within 8-16 months.
Almost 80 percent of patients that have a recurrence of uterine leiomyosarcoma, the cancer has spread to other areas of the body. When the cancer spreads it is called metastatic leiomyosarcoma. At this point the cancer is classified as either state III or stage IV, and the five-year survival rate drops from 50 percent, for non-metastatic leiomyosarcoma, to about 4-16 percent.
While fibroids are benign and non-cancerous the can cause heavy uterine bleeding, pelvic pain, and infertility in many women. Power morcellators are often used to remove fibroids in a surgical procedure called a myomectomy. Power morcellators are also used in hystorectomies, a surgical procedure which removes the entire uterus.
Developed alongside minimally invasive surgical techniques, power morcellators allow fibroid tissue or the uterus to be removed through 2 centimeter incisions.
Surgery for Uterine Cancer
Women undergoing fibroid or hysterectomy surgery are pre-screened for uterine cancer because fibroids can contain cancer cells. Endometrial cancer, cancer affecting the lining of the uterus, is easily detected in pre-surgical screenings. Leiomyosarcoma, cancer affecting the muscle tissue of the uterus,however, is much harder to detect before surgery.
Leiomyosarcoma resembles fibroids in medical imaging and is most frequently diagnosed after surgery when extracted tissue goes for post-surgical pathology.
According to FDA research, 1 in 350 women undergoing a fibroid removal procedure are at risk of developing metastatic leiomyosarcoma if undiscovered leiomyosarcoma exists.
Many women that had laparoscopic procedures involving power morcellation were not made aware of the risks associated with the use of the device. They were not informed about the potential of the device to spread undetected cancer cells, despite the fact that both the medical community and manufactures have known about this possibility for decades.