A wrongful death lawsuit was filed against a power morcellator manufacturer just months prior to the FDA issuing a “black box” warning on the medical device.

A Pennsylvania man filed the power morcellator lawsuit against LiNA Medical US after the untimely death of his wife, allegedly caused by use of a power morcellator during a hysterectomy procedure. The plaintiff claims his wife, 53, had no symptoms of metastatic cancer before the procedure but was diagnosed with aggressive uterine sarcoma cancer just nine days after surgery.

The power morcellator lawsuit claims manufacturers marketed the product as a safe option for laparoscopic surgery knowing that the medical tool could cause unsuspected cancer tissues to spread throughout the body. The plaintiff further contends that the morcellator makers gave no warnings of the high risk of developing uterine sarcoma linked to using power morcellators.

Morcellation Cancer Risks

The appeal of using a power morcellator is simple as it was designed to provide patients with a shorter post-operative recovery time since its less invasive than traditional abdominal surgery.

However, recent studies have found that using a power morcellator on cancer tissues may have deadly consequences. And because there’s not a way to test to see if uterine fibroids are cancerous before surgery, morcellation use is very risky.

Researchers have determined that one in 350 women who use a power morcellator for a myomectomy or hysterectomy procedure are later diagnosed with uterine sarcoma. 

FDA “Black Box” Warning

After discovering the link between power morcellator and uterine sarcoma, the FDA issued a black box warning on all new and existing devices. The black box warning is the strongest caution before the FDA will remove the product off the shelves completely.

The FDA also addressed what action patients, doctors and manufacturers should take when it comes to morcellator use:

• Patients should find out if a doctor plans to use a power morcellator during a laparoscopic hysterectomy or myomectomy.
• Doctors are asked to limit use of a power morcellator and “carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.”
• Power morcellator manufacturers were asked to include a “black box” warning on all power morcellators.

Some manufacturers decided to voluntarily pull the product off the shelves until the connection between spreading cancer and the medical device is better understood.

Morcellator Cancer Lawsuits

Hundreds of women and their families have already filed power morcellator lawsuits across the United States and the numbers of claims continues to grow. In some cases, families who lost a loved one due to power morcellator cancer file wrongful death lawsuits like this one.

Power morcellator lawsuits claim manufacturers failed to warn the medical community and patients of the life-threatening risks involved with using the medical tool. Plaintiffs are also bringing other charges against manufacturers including false advertising, misrepresenting a product, concealing information and negligence.