Verdict against Johnson & Johnson in a vaginal mesh case. The verdict included $100 million in punitive damages and is the largest contested liability verdict in Pennsylvania history. (McFarland)
A surgical device called a power morcellator used to perform hysterectomies and remove uterine fibroids may dangerously spread cancer in women. The government advised doctors to stop using the electronic tool and its manufacturer issued a worldwide recall.
If you or a loved one suffered the onset or spread of cancer following a hysterectomy or fibroid removal surgery using a power morcellator, you should contact a morcellator attorney about a possible lawsuit.
Kline & Specter, PC, with more than 40 attorneys, five of whom are also doctors and two who are OB/GYNs, has the experience and expertise to litigate cases involving medical devices such as power morcellators. Get a free and confidential evaluation of your case today!
A recent report by the U.S. Government Accountability Office found that power morcellators were used for decades in gynecologic surgeries with approval from the Food and Drug Administration but without prior rigorous testing, according to a Feb. 9, 2017 article in The Philadelphia Inquirer. (Read the article) Only in 2014 did the FDA warn that the tissue-cutting device could spread and worsen uterine cancer.
Morcellators use a spinning blade to dissect the uterus or uterine fibroids so they can be more easily removed through a small incision in the abdomen, or a laparoscopic procedure. However, the blades can sometimes contact fibroids that are malignant and cause the cancer to spread.
One in every 350 women who undergoes a hysterectomy or uterine fibroid removal, called a myomectomy, has an unsuspected form of cancer called uterine sarcoma. If a morcellation is perfomed on one of these women, the cancerous tissue can spread in the abdomen and pelvis, “significantly worsening the patient’s likelihood of long-term survival,” according to the FDA.
The federal agency has recommended that doctors stop using the power morcellators, and Johnson & Johnson’s Ethicon unit, the manufacturer of the device, suspended sales and distribution and also was to ask surgeons to return the devices in what it termed a “worldwide market withdrawal.” In November 2014, the FDA announced it was posting a "boxed" warning on the devices, the strongest type of labeling a product can have while remaining on the market.
An estimated 50,000 operations using morcellators to remove tissue containing fibroid tumors are performed each year.
FDA News Releases:
Johnson & Johnson pulls power morcellator; surgical device had sparked controversy, The Washington Post, 7/30/14
Johnson & Johnson Pulls Hysterectomy Device From Hospitals, The Wall Street Journal, 7/30/14
Johnson & Johnson Praised for Taking Uterine Surgery Tools Off Market, The New York Times, 7/31/14