Every year there are over 600,000 hysterectomies nationwide. Over the past five years vaginal and laparoscopic hysterectomies have become the recommended technique over abdominal hysterectomies because of shorter hospitalization, fewer infections, as well as a faster return to normal activities.
Unfortunately, approximately 15% of all laparoscopic hysterectomies require a technique called “morcellation” that in some women has led to the spread of cancer resulting in death within 5 years of the surgery. The morecellator is the direct cause of this medical device injury.
A morcellator is a surgical device that grinds and chops tissues during surgery into smaller pieces, allowing them to be extracted during a laparoscopic procedure.
The FDA approved the use of gynecologic morcellators in 1995 by the controversial 510(k) process that allows medical devices to bypass the normal procedures to study, test, and scrutinize the effectiveness and risks, prior to being marketed for use. Johnson & Johnson, after an FDA Warning in April 2014, stopped sales of this medical device and Wolf Power Morcellator has been sued in California after women developed metastatic leiomyosarcoma cancer following laparoscopic hysterectomy utilizing a morcellator.
Morcellators are often used during hysterectomies to treat women with non-cancerous fibroid tumors. The problem with using morcellators is sometimes pathologists don’t know until after the surgery if there was an undiagnosed uterine leimyosacrcoma.
By mincing up this tissue at the time of surgery with a morcellator the tumor, which usually has an excellent prognosis for survival, can spread into the abdominal cavity. With morcellation, spread of the disease occurs 26% to 64% of the time. Fewer 50% of women survive for five years.
Recognizing that there is no pre-operative test that reliably identifies the presence of leiomyosarcoma, hospitals are announcing they will no longer be performing laparoscopic hysterectomies or fibroid removal surgeries with morcellators due to the risk of personal injury and death.
Lawsuit against Manufacturers
This is a product liability lawsuit against the manufacturers of this device because they either knew or should have known this product increases the risk of spreading an occult leiomyosarcoma. If you have metastatic uterine cancer or know someone who died of metastatic uterine cancer after a laparoscopic hysterectomy, Dr. Greg Vigna can review the records to determine if you or your family member deserve compensation from the manufacturers of this medically unsafe and defective medical device.
Graphic: CDC/ A. Elizabeth Plott, C.T.(ASCP)
