Morcellator Devices Lawyer
Power Morcellators are electronic medical devices used in myomectomy and hysterectomy procedures. These devices use spinning blades to break up fibroid tissue, which can then be easily removed by the surgeon. Morcellation surgery is minimally invasive and often the preferred method for these types of procedures. The removal of such fibroids is supposed to reduce the risk of intraoperative and postoperative problems such as infection, bleeding, deep vein thrombosis, enlarged uterus, and other injuries.
Unfortunately, morcellator use has been linked to severe complications. Recently, these devices have come under FDA scrutiny for spreading undetected dormant cancer cells located in the uterus to other organs and tissues in the body. Our morcellator devices lawyers can work with you to demand compensation for any injuries or harm you have suffered.
What Are Complications Of Morcellator?
The use of power morcellators has been found to exacerbate the risk of cancer or spread cancer unknowingly through the body because the cancerous cells are hidden or mistake for uterine fibroids. During the morcellation process, the fibroids are ripped to shreds in order to make for easier removal. Unfortunately, fibroids are hard to distinguish from Uterine Sarcoma (Metastatic Leiomyosarcoma in particular), a deadly and unpredictable form of cancer that is very hard to detect and often remains dormant for years at a time. When the morcellator is used to then remove what is assumed to be a benign fibroid, there is an extremely high risk that it will instead shred cancerous tissue, thus spreading the malignancy throughout the uterus and others parts of the body. Metastatic leiomyosarcoma is among one the severe complications that are believed to be spread by these defective medical devices.
It is estimated that 600,000 hysterectomies are performed in the U.S. each year, 90% of which are for the treatment of benign tumors called fibroids. After surgery when the presumed fibroids are tested, about 1 in 350 prove to be cancerous.
If power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.
On April 29, 2014, Johnson & Johnson suspended the sale of its morcellators pending further review. A number of hospitals have restricted the use of morcellators. On April 17, 2014, the FDA formally discouraged the use of morcellators for hysterectomy and myomectomy procedures. To learn how this information could effect your morcellator device case, you should speak with an experienced lawyer.
Can Power Morcellators Cause Cancer?
Power morcellators are tools used by doctors in hysterectomies, as well as other minimally invasive procedures to remove uterine fibroids. Surgeons make small incisions to “morcellate” or chop up fibroids and tissue in order to cut them into smaller pieces. Surgeons then vacuum the residue out of the area.
The concern, however, is the morcellator has a possibility of spreading bits of the uterine or fibroid tissue to other tissues and organs, spurring on new growths.
Power Morcellators and Endometrial (Uterine) Cancer
While most cases of endometrial cancer occur in accordance with the aforementioned risk factors, there have been instances in which development occurred after failed medical efforts for other complications.
Power morcellators are devices used to break up tissue in the uterus to decrease the difficulty of a myomectomy or hysterectomy procedure. However, the device poses a major health risk in potentially spreading dormant endometrial cancer cells to other parts of the body. An individual can contain dormant cancer cells in their uterus that may not pose a risk to their health at that moment.
However, when a power morcellator breaks apart tissue, the blades may cause dormant cells to become active and spread to other organs close to the uterus. When these cells are able to spread, cancer may begin to rapidly develop in other organs.
Power Morcellators and Stomach/Abdominal Cancer
New growths spurred by the spread of uterine or fibroid tissue can cause, infection, bowel obstruction, or in some cases malignant cancer cells can become present. When cancer metastasizes, it infects other organs, such as the stomach, liver, ovaries, and lungs. This form of cancer is called metastasized leiomysarcoma and is classified as a stage III or IV cancer and has a much higher fatality rate.
Which Companies Manufacture Morcellator Devices?
The following medical device companies manufacture Morcellator devices:
- Gynecare Morcellex
- Gynecare X-Tract
- Morcellex Sigma
The GYNECARE MORCELLEX™ Tissue Morcellator is a single-patient-use device. The device is inserted into the patient with the use of the provided single-patient-use Obturator. The device allows tissue to be grasped with a standard grasping instrument extended through its central lumen.
The GYNECARE X-TRACT Tissue Morcellator provides a unique tissue stabilizing sheath so that surgeons can effectively remove tissue with few instrument passes and minimal hand fatigue. This tissue Morcellator quickly and effectively extracts large volumes of tissue, allowing surgeons to employ a minimally invasive approach that can help reduce operating time.
FDA Issues Black Box Warning
The FDA found that 1 in 350 women who underwent a hysterectomy or myomectomy for the treatment of fibroids have unsuspected cancer, including the very aggressive leiomyosarcoma. In response to the study, the FDA issued its strongest black box warning on the device but did not outright ban it. Very large insurance companies, such as Aetna and UnitedHealth, have stopped covering use of the device. Johnson & Johnson’s division Ethicon recalled its power morcellator and sent out a strong warning to surgeons, but many power morcellators remain in the market and in use. Similarly, some companies, including Nashville-based hospital chain HCA Holding, Inc., have announced they will stop the use of power morcellator in their facilities.
According to the agency’s official release, because of the availability of safer alternative options, it is warning against the use of power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of fibroids. The release goes on to detail there is a strong warning on the risk of spreading unsuspecting cancer. The FDA has also requested that manufacturers of the device add a new black box warning to the surgical tool’s label. The black box warning is the FDA’s strongest safety alert. The alert is to include information on the risk of previously undetected cancer within the uterine tissue.
Furthermore, the new black box warning also cautioned against the use of the power morcellator in women who are entering or have been through menopause, and who are candidates for uterus removal either through the vagina or via minilaparotomy. This, combined with the above warnings, would apply to most of the women who would require a hysterectomy or fibroid removal – the two most common circumstances in which power morcellators are used in surgery.
Be aware of the following new contraindications recommended by the FDA:
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
- Carefully consider all the available treatment options for women with uterine fibroids.
- Thoroughly discuss the benefits and risks of all treatments with patients.
Despite the documented risks and the FDA’s warnings, many hospitals still employ the use of power morcellators in fibroid removal or hysterectomies. As such, women continue to be at risk of contracting cancer after a procedure involving a morcellator device and should speak with an attorney about their legal options.
Work with an Attorney on a Morcellator Device Lawsuit
Our morcellator devices lawyers can help if you or someone you care about was harmed by morcellator surgery.
Lawsuits have been filed against the device maker by both patients and their families seeking compensation for injuries caused by the dangerous device. This includes Scott Burkhart, who filed a lawsuit against LiNA medical after his wife died of myelosarcoma following a uterine fibroids removal procedure in 2012. You may be entitled to a settlement.
Below is the criteria required to file a morcellator lawsuit against the device manufacturer:
- Must be female
- Underwent hysterectomy or surgery to remove fibroids where a morcellator was used
- Subsequently diagnosed with uterine sarcoma, a type of cancer, within weeks to months