The United States Food and Drug Administration recently took action designed to reduce risks associated with the use of laparoscopic power morcellators in fibroid surgery.
The federal agency’s press release states that such morcellators should not be used in any area in which there is known or suspected cancerous tissue. After the FDA analyzed available data, the federal agency determined that about 1 in 350 women undergoing fibroid surgery in the form of a hysterectomy or a myomectomy was found to have a previously undiagnosed uterine sarcoma-type cancer. When laparoscopic power morcellators are used in such patients, it is possible that cancerous tissue will be spread to elsewhere in the abdomen or pelvis. This outcome could shorten the patient’s life, the FDA warns.
IIE Guidance Issued
In response to the data, the FDA, through what is termed an “Immediately in Effect” guidance (IIE), recommends that manufacturers of the devices include product labeling that notes two contraindications along with a boxed warning. An IIE guidance is typically used when the FDA wants to immediately address a significant health issue that affects the public. The new IIE guidance applies to any new power morcellators as well as to any that are being marketed right now.
Label to Warn of Potential for Spreading Cancer
A boxed warning will communicate to both medical providers and to patients that since unsuspected cancer may exist in certain uterine tissue, laparoscopic power morcellators used in fibroid surgery may spread this cancer and potentially shorten the life span of those patients. The FDA states that patients should be informed of this possibility when fibroid surgery using laparoscopic power morcellators is considered. The agency also says that other surgical options are often available to patients with fibroid problems.
Agency Lists At-Risk Groups
The FDA specifically warns against the use of laparoscopic power morcellators in women that are peri-menopausal or post-menopausal, or candidates for intact tissue removal through either the vagina or via a mini-laparotomy incision. These patient groups actually represent the majority of women that require fibroid surgery.
Have You Become Sick or Injured as the Result of the Use of a Medical Device in Surgery?
If you have suffered any adverse outcome because of a defective or improperly used medical device during surgery, you may be entitled to a monetary compensation. Attorney Group can help you decide if you have a claim because of your pain and suffering, medical bills and lost wages as a result of the improper use of a medical device. Call Attorney Group to learn more about how we can help you file a lawsuit with one of our affiliated attorneys at no out-of-pocket cost to you.