Morcellator Lawsuit Settlement Funding and Lawsuit Help
Laparoscopic Power Morcellators and Possible Uterine Cancer
Power morcellators were initially approved in 1993 by the U.S. Food and Drug Administration (FDA).
Power morcellators have been used in different laparoscopic surgeries including hysterectomy and myomectomy procedures as well as laparoscopic spleen and renal surgeries. In July of 2014, the FDA concluded that the risk for spreading cancer is 1 in 350. Due to the discovery that the device may actually spread cancerous tissue, the FDA recommended that doctors stop using them.
FDA Warnings and Possible Side Effects
In April of 2014, the FDA issued a warning letter stating that the use of power morcellators may actually spread cancers when being used to remove fibroid tumors. After the warning letter came out, Johnson & Johnson suspended additional sales of three Ethicon power morcellator device models.
In July of 2014, the FDA’s Medical Devices Advisory Committee held a meeting to highlight the problems associated with the devices. Morcellation devices may actually disseminate malignant tissue, and the FDA concluded that the risk for spreading cancer is 1 in 350. Due to the discovery that the device may actually spread cancerous tissue, the FDA recommended that doctors stop using them. The FDA also concluded that surgeons who do use power morcellators should inform patients of the risks of the use of the devices. They also suggested serious warning statements should be added to product packaging, and recommended increasing the device classification to the higher Class II category. An FDA Class II recall typically indicates that a device may cause “temporary or medically reversible” health problems, as well as a remote possibility of serious health problems.
Also in July of 2014, Johnson & Johnson issued a voluntary recall of the following three laparoscopic power morcellators from hospitals worldwide: the Gynecare Morcellex, the Morcellex Sigma, and the Gynecare X-Tract.
Morcellation devices are used during several medical procedures. While the morcellator device provides a less-invasive surgery and quicker recovery time, the following have been listed as potential side effects:
- Spread of malignant tissue
- Advanced-stage cancerous growths
- Metastatic leiomyosarcoma, an aggressive uterine cancer
With as many as 50,000 surgeries a year involving morcellation of fibroids, Johnson & Johnson is a market leader in morcellation device sales. Several lawsuits have already been filed against Johnson & Johnson relating to the power morcellation devices. Among those who have already filed are patients who were diagnosed with advanced stage cancer following the procedure with the morcellation device. Johnson & Johnson is also facing thousands of lawsuits over their faulty hip and pelvic mesh devices.
Morcellator Wrongful Death Suit Settlement
This case was one of the first laparoscopic power morcellator lawsuits filed in federal court, and according to the U.S. FDA, as many as 1 in 350 women are “suspected of having undiagnosed uterine sarcoma that may be spread during morcellation.” The victim’s husband filed the suit, stating she had no evidence of cancer or disease prior to her surgery in March of 2012, however, about a week after she had the procedure, doctors told her she had cancer, and she died at 53 – only 11 months after the surgery.
Get the help you need on your Morcellator Lawsuit Claim
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