Lawyers and Settlements
Advertisement
Home Page >> Hot Legal Issues >> Laparoscopic Power Morcellation FDA Warning >> FAQ / Info

FDA Warns Against Laparoscopic Power Morcellation FAQ

What is laparoscopic power morcellation?

Laparoscopic power morcellation is used during hysterectomy or myomectomy to treat uterine fibroids by dividing the uterine tissue into smaller fragments that can be removed through an incision in the patient's abdomen. Uterine fibroids are non-cancerous growths that develop in the wall of the uterus. Although they often do not cause any health problems, they are associated in some women with heavy or prolonged menstrual bleeding, pelvic pressure, pain and frequent urination.

What are the concerns about laparoscopic power morcellation?

Although laparoscopic power morcellation is used to treat uterine fibroids that are non-cancerous, in some situations the patient may have cancer (uterine sarcoma) but not realize it. Laparoscopic power morcellation could increase the risk of cancerous tissue being spread from the uterus into the abdomen and pelvis, decreasing the chances of long-term survival.

What does the FDA say about laparoscopic power morcellation?

The FDA has convened an advisory panel concerning laparoscopic power morcellation. The panel has recommended obtaining informed consent regarding the risks of morcellation and including a boxed warning on the labels of laparoscopic power morcellators. The panel also recommended that strategies be developed to lessen the risks of adverse events during treatment and that doctors determine patients that may have sarcoma before treatment begins.

The panel was not asked to consider either taking the morcellators off the market or reclassifying them.

On April 17, 2014, the FDA issued a safety communication warning that laparoscopic power morcellation, when used during hysterectomy or myomectomy in women with uterine fibroids, poses a risk for spreading unsuspected cancerous tissue in the abdomen. The FDA noted that health care providers and patients should consider alternative treatment options and discouraged “the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The FDA noted that approximately 1 in 350 women undergoing hysterectomy or myomectomy for fibroids actually has unsuspected uterine sarcoma, a type of uterine cancer. In these women, the use of laparoscopic power morcellation could potentially spread cancerous tissue throughout the abdomen, “significantly worsening the patient’s likelihood of long-term survival.”

Have lawsuits been filed concerning laparoscopic power morcellation?

Yes. So far, at least one lawsuit has been filed against the company that makes laparoscopic power morcellators. The lawsuit alleges that the laparoscopic power morcellation resulted in cancerous tissue being spread in the patient’s abdomen.

Is it too late to file a lawsuit?

No, although the limit for filing a lawsuit depends on your state’s statute of limitations. If you had a hysterectomy or myomectomy that involved laparoscopic power morcellation and were later diagnosed with cancer or had the cancer spread, you can contact an attorney who can speak with you about your options.

Are hospitals still performing laparoscopic power morcellation?

Some hospitals have reportedly stopped using power morcellation, although the procedure has not been banned. Some hospitals are reportedly only using the procedure if a bag is used to contain the fibroids and uterine tissue and prevent the fragments from spreading into the abdomen.

Has laparoscopic power morcellation been banned?

No. The procedure has not been banned.

Have laparoscopic power morcellation devices been recalled?

On July 30, 2014, Ethicon, a division of Johnson & Johnson, sent a letter to health care providers announcing a “worldwide voluntary market withdrawal of all Ethicon Morcellation Devices that currently remain in the market.”

What should I do if I think I have been harmed by the use of laparoscopic power morcellation?

If you had a laparoscopic power morcellation hysterectomy or myomectomy for uterine fibroids and were diagnosed with cancer or had your cancer spread, speak to an attorney to discuss your options. If you had either procedure done and have symptoms of cancer, please seek medical attention.
Please click here for a
free evaluation of your Laparoscopic Power Morcellation case
Please click here for more
Laparoscopic Power Morcellation info and legal news


Last updated on Sep-2-14