Recent FDA Alert Warns of Spreading Undetected Cancerous Tissue When Undergoing Surgery with a Power Morcellator.
What is a Power Morcellator?
A power morcellator is a surgical device commonly used by gynecologists to divide and remove large tissue masses during laparoscopic uterine surgery. The device gets its names from the manner in which it minces, or morcellates, a uterus into smaller pieces during a laproscopic surgery so the uterus can be removed through the abdomen. Electric morecellators contain tiny rotating cutting blades which break masses up into tiny pieces. The device then acts as a vacuum in order to remove the smaller pieces.
Dangers of Using a Power Morcellator
The FDA has discouraged the use of power morcellators in laproscopic procedures removing the uterus or uterine fibroids in women. The FDA News Release reports that there is a great deal of risk of spreading cancerous tissues inside the body when using the device.
According to the data analyzed by the FDA, about 1 in 350 women who are required to undergo a hysterectomy or the removal of uterine fibroids, unknowingly have a form of uterine cancer (commonly referred to as a uterine sarcoma). If the power morcellator device is used, there is a large risk that the uterine cancer tissue will be minced up with other tissue and spread to other areas of the body in the removal process. Reports indicate that women over 65 years of age are the most at risk of having hidden uterine cancers capable of being spread.
Power Morecellator Alternatives
Laparoscopic morecellators are one of several treatment options available to patients for the removal of uterine fibroids or the uterus. Some of the other treatment methods available include:
- Traditional Hysterectomy Surgery
- Laparoscopic Hysterectomy w/o Morcellation
- Non-Surgical Options
The FDA has advised healthcare providers that based on currently available information:
- The FDA discourages the use of the power morcellators when treating uterine fibroids
- Women suspected or known of having uterine cancer should never undergo morcellation
- There are other safer treatment options available and all options should be considered
- Patients must be informed of all known risks and benefits so they can make an informed decision
The FDA has taken their warnings a step further and stated that if a medical processional still chooses to subject the patient laparoscopic power morcellation despite the discouragement, they should:
- Provide patients with the specific advice that their uterine fibroids may contain unknown cancerous tissue that could spread through morcellation, making their problems worse.
- Be advised that certain members of the medical community are advocating the use of a specimen bad during the procedure in an attempt to contain some potentially cancerous tissue and reduce the risk of additional contamination.
Women should specifically ask their medical provider if a power morecellator will be used during their procedure, and discuss if this is the best health option for their situation. In addition, if a power morcellator is used and fibroids are removed, the removed fibroids will be tested for cancer upon their removal. If it is discovered that cancerous fibroids were found, the patient will be informed and should immediately consult with their health care professional for additional treatment.
The medical and scientific community is working to develop imaging that would allow the identification of cancerous fibroids prior to surgery. They are also working to develop morcellation techniques that occur entirely within a bag to prevent any spread of cancerous tissues. Until then, power morcellators pose a great risk for women undergoing uterine surgery.
Are There Any Benefits to Morcellation?
It is reported that the morcellation technique is minimally invasive and large uterine fibroids can be removed through small incisions. It is also reported that mocellation results in faster recovery times, less pain following surgery, and lower risk of infection. However, these alleged benefits seem like a small cost to pay in exchange for the reduced risk of spreading cancer throughout the body.
Power Morcellator Lawsuits Allege Makers Hid Known Risks
The Pittsburgh Business Times alleged that Johnson & Johnson may have known of the power morcellator risks before the FDA warnings. 8 years before Johnson & Johnson suspended their power mocellator sales, a pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania, wrote a letter to the company specifically asking them to reconsider the use of power morcellators because of the risk of spreading harmful tissue when removing the uterus or uterine fibroids following surgery.
Despite the information, Johnson & Johnson continued to market and sell their power morcellator, simply adding a precaution in the labeling contained in the instructions for use of the device. It was not until the Food and Drug Administration issued a warning that they discontinued their sales and marketing.
Companies that market and sell devices they know to contain dangerous side effects are under a strict duty to warn the public. If a company fails to warn the public, they are responsible for the harm caused to unsuspecting victims and their families.
Victims Compensation for Power Morcellator Injuries
Those injured by power morcellators may receive reimbursement for their medical expenses, lost wages, life style changes, wrongful death, future medical expenses, and other related damages. Future medical expenses are a large part of the compensation in power morecellator lawsuits. Victims who have had cancer spread throughout their body as a result of the morcellator injury may require future surgery, chemotherapy, or numerous other cancer treatments. These procedures are incredibly expensive and can last a lifetime, taking an enormous financial, mental and physical toll on the victims.
If you have lost a loved one, or are suffering from uterine cancer following a power morcellator surgery, call us today for a FREE CASE REVIEW.