Complications in the Female Reproductive System Frequently Require Medical Interventions.
Women of all ages experience problems related to their reproductive system, especially in their uterus, ovaries, or fallopian tubes. For instance, thousands of women every year are diagnosed with some form of cancer affecting this part of their body, and even more suffer from such common problems as heavy periods, benign tumors, vaginal bleeding, and pain, to name a few. Often, doctors start with less intrusive forms of care to alleviate this pain. For instance, they may prescribe over-the-counter or prescription medication.
They may also recommend physical therapy to manage the discomfort (especially if the condition generates back pain). However, in many instances, these actions will not entirely address or remove the underlying medical issue. Therefore, doctors regularly advise patients to undergo either hysterectomies or myomectomies. The former involves the removal of affected part of the reproductive system (i.e. uterus, cervix, ovaries, etc.). This can be partially or completely, whatever is needed and recommended. The latter is a more targeted procedure. It aims to target and take out benign tumors (fibroids) in the reproductive system. Unlike a hysterectomy, it largely leaves the unaffected areas of the body intact and undisturbed.
How Morcellators Work to Assist Doctors in Performing Various Procedures
Sometimes, when women present some of the problems described above to a doctor, he or she will recommend the use of a Morcellator to solve the medical issue. A Morcellator is a device that has grown rapidly in popularity since its arrival onto the medical scene nearly twenty years ago. Through a process known as morcellation, it attempts to “mince” the parts of the reproductive system (i.e. uterus, cervix, ovaries, etc.) that are negatively affecting the body and then remove them. By mincing, it is meant that the Morcellator actually cuts up the troubled areas in order to make their removal easier.
The instrument is able to extract these body parts due in large part to its skinny, tube-like structure with a hallow body. One benefit to this procedure is that it is laparoscopic in nature. This means it causes minimal damage upon impact and can operate far and away from where the actual entry point of the surgery takes place. Yet, laparoscopic surgeries also have significant downsides. For example, they can take more time than traditional operations; they can require multiple entry points which will add to the overall effect of the procedure; and, consequently, they can result in numerous, unintended complications.
FDA Warns Against the Dangers of Laparoscopic Morcellation
Recently, the U.S. Food and Drug Administration (FDA) issued a warning against the use of laparoscopic morcellation in hysterectomies and myomectomies. The contents of which can be viewed in full here:
The main message from this warning was that the use of Morcellators in these procedures may have the unintended consequence of spreading a type of cancer that is already found in women, known as uterine sarcoma. While the percentage of women that contain this disease is small (less than 1% of all women undergoing hysterectomies and myomectomies), the threat of it spreading with the use of laparoscopic morcellation is real. The FDA encourages Morcellator manufacturers to prominently display this risk on the product label.
The warning also gives recommendations to health care providers, including:
- Carefully review every option available for treatment prior to recommending any course of action for a woman with uterine tumors (fibroids).
- Inform patients of the benefits and risks associated with laparoscopic morcellation, including the possible spread of cancer and its negative implications on the likelihood of fertility.
- Remember to notify patients of the FDA warning regarding laparoscopic morcellation, which should read as follows:
“The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
The warning also gives recommendations to women, including:
- Question your doctor on the risks and benefits for every type of procedure possible for you medical issue.
- If laparoscopic morcellation is recommended for either a hysterectomy or myomectomy, ask the doctor why that course of treatment is preferred to others, if possible.
- Follow up with your health care provider to check for the presence of cancer or its growth in the tissue operated on and the surrounding areas.
Alternatives to Laparoscopic Morcellation
In an attempt to avoid the problems associated with laparoscopic morcellation, many patients and their doctors are turned to alternatives to this procedure. Some options include the following:
- Traditional Surgery: As opposed to laparoscopic morcellation, traditional surgical methods, such as a standard vaginal hysterectomy, are commonly seen as less risky for a variety of reasons. Doctors employing these procedures often attempt to remove the entire affected area of the body. Consequently, there is less time in surgery and in recovery. Also, the spread of cancer is less likely with these “en-bloc” operations. However, it is more invasive and scarring upon entry than laparoscopic approaches.
- Alternative Morcellation Techniques: Generally, morcellation involves the “mincing” and extraction of affected body tissue. It literally, cuts up the area that is causing problems and this mincing often adds complications to the operation, especially involving the spread of cancer. Therefore, doctors have begun employing alternative morcellation techniques, including those that do not involving mincing. For example, some health care providers have started utilizing laparoscopic morcellation to disconnect the area, place it in a bag, and then remove the package intact. This attempts to reduce the complications of this procedure while maintaining minimal invasiveness.
- Non-Surgical Options: Being diagnosed with a condition that typically implicates laparoscopic surgery does not always require it. Numerous non-surgical methods attempt to reduce and eliminate the underlying causes of the illness (such as fibroids) without forcing a patient into the operating room. Some of these options include prescription medication, ultrasound detection, and artery embolization but you should speak with your doctor to understand every available treatment.
Do you have questions about a complication following a morcellator procedure? Get more information about morcellator lawsuits here.