FDA Cautions Against Some Laparoscopic Surgeries

Laparoscopic surgeries – those done “robotically” through small incisions – have become preferred by doctors and patients in many instances, because they mean less time in the hospital, quicker recovery and minimal scarring. On April 14, 2014, however, the FDA issued a Safety Communication about the device used to accomplish some of these surgeries, specifically hysterectomies and surgeries to remove fibroid tumors in women.

The Dangers

The surgical device is called a morcellator, and it is produced by five companies, including Johnson & Johnson. The surgeon inserts the morcellator into the uterus through a small incision. Its blades chop up the tissue so it can be removed through the same tiny incision. What they are finding, however, is that when women have an undiagnosed cancer, a uterine sarcoma, the cancerous tissue also gets divided and may spread malignant cells throughout the abdomen and pelvis, “significantly worsening the patient’s likelihood of long-term survival.”

The FDA has estimated morcellators are used about 50,000 times each year in the U.S. for operations to remove fibroid tumors, which are common but often painful uterine growths. Fibroids can also necessitate a hysterectomy, the second most common surgery for women. Some estimate that about 40% of the 500,000 hysterectomies performed annually in the U.S. are due to fibroid tumors, although not all hysterectomies are done laparoscopally.

Sales Halted Amid Risks

Since there is a 1 in 350 risk that a woman undergoing surgery to remove these growths has undetected cancer, the FDA is discouraging the use of morcellation during hysterectomy or fibroid removal sugeries. Johnson & Johnson has halted world-wide sales, distribution and promotion of their power morcellators but has not permanently pulled them from the market, and doctors and hospitals are not prevented from using the devices already in inventory.

On March 14, 2014, a lawsuit was filed in the U.S. District Court, Eastern District of Pennsylvania, by a man whose wife underwent a minimally-invasive robot-assisted hysterectomy on March 6, 2012. Prior to her surgery, there was no evidence that she had cancer. Nine days later, she was informed that she had cancer. Less than a year later, on February 2, 2013, the 53-year-old woman died as a result of the disease. The lawsuit alleges that she had not been warned prior to her surgery that morcellation could result in the seeding of an undiagnosed sarcoma throughout her abdominal cavity.

Pending Litigation

On May 1, 2014, a lawsuit was filed in New York federal court on behalf of a woman who claims the use of a power morcellator during a robotic hysterectomy caused the spread of an undetected uterine cancer. She was 41 years old when she was told her fibroid tumors could cause stage one cancer. She agreed to a hysterectomy and morcellation was performed. Two weeks later she was told she had stage four cancer in her abdomen and lungs. She has been given two years to live. Her lawsuit alleges that Ethicon, a Johnson & Johnson unit, and other defendants were aware of the risks associated with their uterine morcellation products and failed to warn that the use of these devices during uterine surgery may promote the spread of undetected leiomyosarcoma, an aggressive form of uterine cancer.

The FDA recommends that women being treated for uterine disease discuss all treatment options available with their doctor, including the risks and benefits of each. If a laparoscopic procedure is recommended, ask if power morcellation will be utilized and question why it is better than other alternatives.

Women who have already had fibroid removal surgeries or hysterectomies using morcellators may now be at risk of serious and aggressive cancer. Patients with persistent or recurrent symptoms should follow up with their doctors immediately.

If you or your spouse underwent a laparoscopic fibroid removal operation or a robot-assisted hysterectomy and a diagnosis of sarcoma followed, you could have a cause of action against the manufacturer of the morcellation device used in the surgery. Call the Louthian Law Firm at 888-440-3211 for a confidential consultation. Our law firm is family-owned and family-focused. We’ll be glad to be of assistance to your family in this difficult time.