Medical device manufacturers may face product liability claims when patients are allegedly 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 has taken action on November 24, 2014 to reduce patient risks associated with these power morcellators.
New Boxed Warning Required
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 apply to new power morcellators, as well as to any that are currently being marketed.
Possible Spreading of Cancerous Tissue
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.
Reasons For FDA Action
When the Food and Drug Administration 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.
The Manufacturer’s Response
One manufacturer of a power morcellator has even threatened legal action if surgeons don’t stop talking about the risks associated with the devices. This despite the high-profile controversy involving anesthesiologist Amy Reed’s death, allegedly due to a morcellator spreading cancer.
A patient that suffers an adverse outcome due to the use of a laparoscopic power morcellator may be able to seek compensation for certain medical expenses, pain and suffering and lost wages. If you had surgery where a power morcellator was used, contact the doctor or an attorney to seek answers to your questions. As always, our firm offers a no cost, no obligation case evaluation to discuss your specific situation and injuries. Contact us to learn more.