In April of 2014, the FDA released a statement that discourages the use of power morcellators during uterine and fibroid removal procedures after it was discovered that the devices could spread undetected uterine sarcoma and cause additional medical complications. Since the release of the statement, Ethicon has ceased the sale and distribution of its morcellators products and several insurance carriers opted to no longer offer coverage for procedures that involved their use. It is suspected, however, that Ethicon parent, Johnson and Johnson was aware of the risks associated with morcellator use eight years prior to the FDA’s statement.
Dangers Associated with Power Morcellators
Power morcellators are devices used during laparoscopic surgeries to cut tissue into pieces small enough to be removed through a small incision site. The procedures are advertised as being less invasive, less painful and requiring less recovery time. The use of a power morcellator disseminates both benign and malignant tissue, however, which can cause any of the following conditions and complications.
- Uterine cancers such as leiomyosarcoma, endometrial stromal sarcoma, carcinosarcoma, and endometrial adenocarcinoma
It has been reported that a pathologist working at Evangelical Community Hospital in Lewisburg, Pennsylvania voiced his concerns about the use of power morcellators in a letter in 2006. In his report, he included the concern that the morcellators could disseminate and spread malignant tissue, resulting in the spread of uterine cancer that has previously gone undetected. It is not always possible to detect uterine cancer prior to these procedures and the spread of malignant tissue increases the risk that women will develop cancer.
Ethicon dismissed the concerns and the only action that was taken was to include a precautionary statement on the products’ labels but to continue widespread marketing and distribution. It was not until the FDA issued its statement in 2014— eight years later— that Johnson and Johnson made the decision to pull the Ethicon products off the market.
As a result, Johnson and Johnson may be found liable for any injuries and deaths that have occurred during or following laparoscopic procedures that involved the use of Ethicon power morcellators. Ethicon is only one of multiple power morcellator manufacturers that have been named in a lawsuit filed in March of 2014 by the husband of a patient who died of uterine cancer less than a year after undergoing a procedure that involved the use of a power morcellator.
Your Legal Rights
If you or a loved one has been injured or has died due to complications posed by power morcellator use, you may be entitled to compensation. It is important that you understand your rights and legal options. Contact us today to schedule a free consultation with an attorney who will examine the details of your case and inform you of everything you need to know about the legal process and how best to move forward. We will never ask for payment upfront and are only ever paid when we collect damages on the behalf of our clients.