ABOUT THE DEVICE
In April 2014, the FDA issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus and uterine fibroids.A power morcellator is an electric surgical device used to cut up large chunks of tissue into smaller pieces. Surgeons use them during procedures such as a laparoscopic hysterectomy or a myomectomy. The devices resemble a drill with sharp blades at the end. Doctors insert the long, tube-like portion into small incisions in the abdomen, perform morcellation of the uterus or fibroid by chopping up the tissue and vacuum it out of the body.
PURPOSE OF THE DEVICE
Surgeons use these devices in women for hysterectomies and removing benign masses called fibroids. But, they may also be used in laparoscopic renal (nephrectomy) or spleen (splenectomy) surgery.
In April 2014, the FDA issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus and uterine fibroids. Based on an analysis of currently available data, it cited a risk of the spread of benign or cancerous tissue to the abdomen in women or men, causing problems.
The FDA intends to convene a public meeting of the agency’s Obstetrics and Gynecological Medical Device Advisory Committee to discuss the possibility of further action.
Some former patients are finding more serious complications and side effects related to procedures in which doctors use morcellators. Recent medical evidence shows the removal of broken up fibroids and tissues may not be 100 percent effective. If any of those tissues contain cancer cells and do not get removed, they get spread to other areas, leading to the development of cancerous tumors.
HOW BRAMZON & ASSOCIATES SPECIALTY LITIGATION LLC CAN HELP
There are an average of 600,000 hysterectomies performed each year, so the potential for patients who may be facing potential complications stemming from those procedures is high.
If you or a loved one underwent a hysterectomy, fibroid, renal or spleen surgery, you should contact Bramzon Law. If you or a loved one underwent a hysterectomy, fibroid, renal or spleen surgery, you should contact Bramzon Law. It’s best to determine whether or not you were treated with one of the laparoscopic models in question before you experience more severe complications and risks.
“Women are already in such a vulnerable position when it comes to their reproductive health, and this is yet another example where it is critical to be proactive,” says Bramzon. “The possibility of greater health complications down the road are too high and too risky to leave the issue neglected and should be addressed immediately if you or a loved one recently experienced some form of laparoscopic surgery.”
For more information, contact Bramzon & Associates Specialty Litigation LLC today to understand your risk exposure and take an active step in ensuring your future health.