In some hysterectomy and myomectomy procedures, power morcellation is a medical operation used to remove non-cancerous growths from the uterine wall.
A device called a morcellator, which contains blades in the shape of tubes and is employed in this technique, is used to separate tissue. Through tiny incisions, the power morcellator can remove undesirable uterine growths.
Power morcellation is frequently promoted as a minimally invasive surgical technique with a quicker recovery than other hysterectomy methods since the incisions required for it are small.
During laparoscopic surgery, doctors typically utilize a power morcellator to slice larger pieces of tissue into smaller ones. Surgeons mostly use them for gynecological treatments such as laparoscopic hysterectomy and myomectomy (removal of the ovaries) (fibroid removal).
However, surgeons also employ them during liver, spleen, and gallbladder removal procedures. The gadgets have blades at the end that resemble drill bits.
In 1991, the U.S. Food and Drug Administration authorized the sale of the first electric morcellator. In 1995, the first laparoscopic morcellator was released. The agency gave the device a class II classification, and the 510(k) process was used to approve its sale. Devices can now be sold without substantial clinical trials because of this method.
The Cook Tissue Morcellator was the first of these products to be sold. Following Cook’s permission, Karl Storz and Johnson & Johnson issued their morcellators. Additionally released without clinical trials were these gadgets. The FDA has since approved a few dozen additional devices.
In the United States, doctors conduct about 600,000 hysterectomies each year. Prior to the FDA warning, power morcellators were utilized by surgeons in around 60,000 hysterectomies and myomectomies annually.
According to the Society of Gynecologic Oncology, Morcellation was created to shrink an enlarged uterus so that it may be removed through tiny laparoscopic incisions or a woman’s vaginal canal. Women can avoid a traditional, open, and more invasive hysterectomy with more blood loss and other problems thanks to the device and procedure.
However, the FDA issued a warning in 2014 that 1 in 350 women who get a hysterectomy or myomectomy may actually have uterine cancer that hasn’t yet been identified. Power morcellators have the potential to distribute malignant tissue throughout the abdominal cavity and exacerbate cancer.
This implies that a tumor may advance from stage 1 to stage 4 after morcellation, making the malignancy more challenging to treat and lowering the likelihood of long-term survival.
The FDA updated its 2014 recommendations for laparoscopic power morcellators in 2017.
Based on its results, the FDA did not suggest a ban or alter its advice to clinicians.
Some hospitals prohibited the equipment after the FDA issued its original warning, and some insurance providers stopped paying for fibroid removal and hysterectomy using the power morcellator. One of the biggest manufacturers of morcellators, Johnson & Johnson, took its products off the market.
What Is a Morcellator’s Mechanism?
To “morcellate” is to divide into smaller parts. With the help of these power morcellators, surgeons can remove fibroids and other tissue through tiny, minimally invasive incisions that are less than 2 millimeters long.
The smaller entrance locations mean that surgeons do not need to make significant incisions through the muscles of the core of the stomach. As a result, patients can recover more quickly and experience less postoperative discomfort and wound problems.
The fibroid or tissue is cut up into tiny pieces and vacuumed out of the abdominal cavity by the doctors using the long, tube-like part of the device, which is inserted into the small abdominal incisions.
Vaginal morcellation and power morcellation can occasionally be mistaken. Power morcellators are rarely used during vaginal morcellation. Instead, the tissue is broken up and removed through the vagina by the surgeon using a knife. Following morcellation of the uterus or fibroids, surgeons use this technique to cut the tissue after placing it in a bag for protection.
The power morcellator’s rotating blades prevent the spread of potentially malignant tissue throughout the abdominal cavity. A safety bag is used to remove the tissue, reducing risk.
Morcellators: Laparoscopic vs. Hysteroscopic
Laparoscopic and hysteroscopic morcellation are the two methods that surgeons most frequently use. A particular sort of manufactured surgical instrument is used for each surgical procedure. Hysteroscopic power morcellators are exempt from the FDA’s warning about spreading malignant tissue.
Hysteroscopic morcellators, according to the FDA, “do not offer the same danger as the devices addressed in this guideline when used in accordance with current indications and directions for use because any sarcomatous tissue present does not reach the peritoneal cavity.”
Hysteroscopic morcellators are built with tissue traps or collecting pouches, in contrast to laparoscopic morcellators. This surgical procedure is more recent, and studies to date show no link to an uptick in cancer cases.
Tissue is contained in a bag for testing after being ground up by surgeons. The tissue is sliced and collected by these devices using mechanical rather than electric energy.
Specific to the laparoscopic surgery, also known as “open morcellation,” the FDA has issued a caution. Through a small abdominal incision, surgeons introduce the drill-like equipment, tear the tissue, and remove it.
However, because the shredding takes place in a public space, tissue fragments, including malignant cells, may spray into the pelvic and abdominal cavities. This category includes the vast majority of morcellators.
What Are a Few of the Risks and Perils Linked to Power Morcellation?
Certain subtypes of uterine cancer have been associated with the spread through power morcellation. This may occur if the morcellator mistakenly breaks up the uterine wall’s malignant cells. In that case, the cancer may spread to other bodily regions, worsening the patient’s general health. The tumorous cells may expand to nearby regions like the pelvic or abdomen.
The hazards of surgery using a morcellator go beyond the threat of cancer spread. A morcellator can even disseminate fibrous tissue that is not malignant. Additional fibroids may develop due to non-cancerous fibroid tissue fusing into other organs and tissues in the abdominal cavity.
Power morcellators do not cause uterine cancer, but they do spread it, especially leiomyosarcoma (LMS). The uterus, abdomen, and pelvis are the most common locations for LMS, a kind of soft tissue sarcoma. However, it can also appear in blood vessels, muscles, fat, and tissues surrounding or supporting organs.
Are Power Morcellation-Related Losses Subject to Legal Redress?
The FDA has issued warnings advising an end to power morcellation in relation to hysterectomies and myomectomies as a result of these known dangers associated with the procedure. Several distributors and makers of morcellators have stopped selling their products as a result of the warnings.
Legal action against these firms may be pursued in the form of a class action lawsuit for injuries or medical issues brought on by power morcellation. Medical malpractice might also be a problem in specific circumstances. Legal remedies for these kinds of situations may involve monetary damages to make up for the patient’s losses.
Do I Require Legal Assistance for Power Morcellation Injuries?
Power morcellation can result in severe medical complications, such as the patient’s uterine cancer spreading to other parts of their body. If you or a loved one has any legal concerns relating to power morcellation, it may be in your best interests to seek a personal injury attorney in your region.
Your attorney can guide you on how to proceed with a claim and look into your state’s injury laws. If you have to appear in court, your attorney can represent and direct you during the proceedings.