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Medical device manufacturers may face product liability claims when patients are harmed by the devices that they make and market. The use of laparoscopic power morcellators in fibroid surgery has been allegedly linked to the possible spreading of cancerous tissue. The Food and Drug Administration (FDA) has taken action on November 24, 2014 to reduce patient risks associated with these power morcellators.
The FDA’s new so-called “IIE Guidance” states that manufacturers are to include a boxed warning regarding contraindications associated with power morcellator use. An “Immediately in Effect” Guidance is issued by the agency when there is a need to promptly address what the FDA considers to be a significant public health issue. The guidance issued on November 24 applies to new power morcellators as well as to any that are currently being marketed.
The FDA states that patients are to be informed of the possibility that unsuspected cancerous intrauterine tissue may be inadvertently spread through the use of laparoscopic power morcellators. The agency also states that other surgical options are typically available to patients that require fibroid surgery.
The use of the morcellators in post-menopausal or peri-menopausal women is specifically discouraged in the FDA announcement. Also, the FDA advises against the use of the medical device in women that are appropriate candidates for vaginal or mini-laparoscopic incision-type tissue removal. Together, these groups of women represent the majority of those that require fibroid surgery.
When the FDA analyzed currently available data, the agency found that about one in 350 females that underwent fibroid surgery was found to actually have an undiagnosed, unsuspected form of sarcoma. If a laparoscopic power morcellator is used in such a patient, there is the possibility that cancerous tissue may spread the sarcoma to the pelvis and/or abdomen. The FDA warns that, in such a case, the life of the patient may be shortened.
One manufacturer of a power morcellator has threatened legal action if surgeons don’t stop talking about the risks associated with the devices. This is despite the high-profile controversy involving anesthesiologist Amy Reed’s death, allegedly due to a morcellator spreading cancer.
A patient that suffered an adverse outcome due to the use of a laparoscopic power morcellator may be able to seek compensation for medical expenses, pain and suffering, and lost wages. If you or a loved one have been injured as a result of a defective medical device, you are urged to contact the Indianapolis Defective Medical Device Attorneys of Wilson Kehoe Winingham. The lawyers at WKW can help you get the compensation you deserve. Call 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation.