A Pennsylvania man is suing the manufacturer of a device used to remove large masses of tissue during minimally invasive surgeries. The man is alleging that the device caused the spread of cancerous tissue during his wife’s hysterectomy, ultimately resulting in her death. The device at issue is known as a morcellator, which operates by breaking up tissue into smaller fragments, allowing a surgeon to remove the tissue through a smaller incision than would be required in standard laparoscopic surgery.
On April 17, 2014, the Federal Food and Drug Administration (FDA) issued a safety communication regarding the use of laparoscopic power morcellation for removal of the uterus or uterine fibroids due to a risk of spreading cancerous tissue. According to the FDA, research indicates that 1 in every 350 women who undergo procedures for the removal of fibroids have an undiagnosed form of cancer known as uterine sarcoma. When women with this condition undergo laparoscopic power morcellation, it can spread cancerous cells elsewhere within the body, potentially reducing the patient’s chances of long-term survival. Based on the data currently available, the FDA recommends that healthcare professionals:
- Be aware of the agency’s position that it discourages the use of power morcellation during hysterectomy or myomectomy for women who have uterine fibroids;
- Refrain from employing power morcellation in women with diagnosed or suspected uterine cancer;
- Consider all other treatment options for women who have medical issues related to uterine fibroids; and
- Fully inform patients of the benefits and risk of all available treatments.
In response to these issues, Johnson & Johnson, the primary manufacturer of the devices, has suspended sales of power morcellators worldwide, according to a report in the Wall Street Journal. The FDA is planning on convening a meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the role of morcellation in the treatment of uterine fibroids, whether there are safety measures that could be implemented to make their use safer, and whether there should be a warning regarding the risk of spreading cancer associated with these devices.
Contact a Products Liability Attorney Today to Schedule a Free Consultation
People who are injured by medical devices or medical malpractice may be able to recover significant compensation for their injuries and other losses. Because these cases often involve complicated and technical issues having to do with FDA rules and regulations and the medical device review and approval process, it is important for victims to discuss their case with an attorney familiar with handling these types of cases. Call the office of Lopez McHugh, LLP today at (877) 737-8525 to schedule a free consultation.