FDA ‘Warns Against’ Certain Laparoscopic Power Morcellator Procedures
Amid the filing of product liability lawsuits in several states, the U.S. Food and Drug Administration on Nov. 24 warned against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. Women who have suffered from the apparent spread of uterine cancer have filed laparoscopic power morcellator lawsuits against the manufacturers.
Laparoscopic power morcellators are medical devices used to divide tissue into smaller pieces in order to facilitate the removal of tissue through small incision sites.
In April, the FDA acknowledged that its analysis of currently available data showed that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. Use of the laparoscopic power morcellator can worsen the condition.
“When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus,” the FDA wrote in April. “Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
The key word in the FDA’s April communication is “discourages.” For, in November, the FDA escalated “discourages” to “warns against.”
“Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids,” reads the agency’s Nov. 24 statement. “In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
“In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.”
The following corporations have distributed or marketed FDA-approved laparoscopic power morcellators in the last year:
- Karl Storz
- Richard Wolf (Manufactured by NouvagAG)
- LiNA Medical
- Trokamed GmbH
- Gyrus (Subsidiary of Olympus Medical)
Johnson & Johnson’s Ethicon division withdrew its laparoscopic power morcellators from the market after the FDA issued its April safety communication.
The FDA in July convened an expert panel to further study the risks of the procedure and to make recommendations as to ways to minimize those risks.
Recovering Compensation for Injuries
Victims may allege in a laparoscopic power morcellator lawsuit, among several claims, that the manufacturer either knew or should have known about the risk of the spread of cancer that the procedure clearly poses. Moreover, as plaintiffs may assert, the manufacturer should have warned about the risk.
A woman diagnosed with uterine cancer following laparoscopic power morcellator surgery has a choice. She can either suffer in silence or hold the manufacturer accountable for the unreasonable and uninformed risks to which she was exposed. This option also holds true for the next of kin of a uterine cancer decedent who was in the same circumstances.
An attorney experienced in trying complex products liability cases, such as a laparoscopic power morcellator lawsuit, is the sort of ally a victim and her family should have on their side. Get in touch with a Maryland law firm skilled in defective products litigation.