The Food and Drug Administration (FDA) has issued a serious warning regarding the use of a medical device during laparoscopic (minimally invasive) surgeries. On November 24, 2014 the FDA updated a pervious warning that it had issued on April 2014.
The device is called a power morcellator which is used in laparoscopic surgeries to divide tissues into small pieces so they can be removed via small incision sites that are made by the surgeon.
Unfortunately, when used to remove uterine fibroids or a uterus during a hysterectomy, it poses a risk of spreading unsuspected cancerous tissue, notably sarcomas.
The FDA is warning against using these machines for the removal of uterine fibroids or for a hysterectomy.
The FDA estimates that 1 in 350 women undergoing these procedures have an unsuspected uterine cancer. The concern is that if a woman has this unsuspected uterine cancer and a power morcellator is used it would increase the risk of the cancer spreading and would significantly worsen the patient’s long term survival.
The FDA makes the following recommendations for women:
• Ask your health care provider to discuss all the options available to treat your condition. There are risks and benefits associated with all medical devices and procedures and you should be aware of them.
• If your doctor recommends laparoscopic hysterectomy or myomectomy, ask him/her if power morcellation will be performed during your procedure, and to explain why he or she believes it is an appropriate treatment option for you.
• If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.
• A number of additional surgical treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy). All treatments carry risk, and you should discuss them thoroughly with your health care provider
If you or a family member have undergone such a procedure and had the unfortunate spread of cancer, you should immediately contact an attorney.
The lawyers at David J. Halberg, P.A. have assisted individuals and families that have been injured as a result of medical malpractice and defective products for over 40 years. If you or a loved one has been injured, it is important to contact a qualified and knowledgeable attorney who can help you, and your family, recover the compensation that you deserve. The lawyers at David J. Halberg, P.A. have years of experience handling these types of cases and are willing to speak to you at any time for a free consultation.