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When Morcellation Surgery Kills

Doctor Comforting Female PatientExactly how many women had to die for morcellation surgery until this innovative surgical device was pulled from use in the medical community? Apparently, that number is high! It took a stern safe communication from the FDA (Food & Drug Administration) before Johnson & Johnson and other minimally invasive surgical device manufacturers pulled morcellators from the medical marketplace.

Out of the more than 500,000 hysterectomies procedures performed in the United States, approximately 30 percent are handled laparoscopically. In addition, nearly the same percentage of all myomectomy (uterine fibroids removal) procedures involves laparoscopic techniques.

A Popular Procedure

The first invention of a power morcellators used for uterine fibroids tumors was released in the medical marketplace in the mid-1990s. Since then, it has become increasingly popular in myomectomy and hysterectomy procedures, allowing doctors to grind dense fibroids and uterine tissue for simple removal through a small incision. Unfortunately, a small percentage of the women undergoing this simplified procedure have undiagnosed sarcoma, which is exacerbated by the medical device.

The tube-shaped power morcellation device is narrow in design, and can be easily inserted through the patient’s abdominal wall through a tiny incision, usually made in the navel. Its rotating blades cut into the uterus and/or uterine fibroids grinding them into tiny fragments, which are then removed with a vacuum.

Unfortunately, in an open morcellation procedure, many of the tiny fragments are easily spread into the peritoneal cavity, landing around other organs including the bladder, rectum, intestines and others. If any of the tissue was cancerous, it can easily take hold in these other areas immediately. Uterine sarcoma is classified in one of three different categories including:

  • Common Endometrial Stromal Sarcoma – low-grade growth in the endometrium
  • Uterine Leoimyosarcoma (LMS), usually grows on the muscular uterine wall (myometrium)
  • Undifferentiated Sarcoma – Significant aggressive growth in the endometrium

Laparoscopic Gynecological Procedure Benefits

Doctors have long known that laparoscopic surgery is beneficial to women having abdominal procedures. This is because it often produces a variety of advantages over traditional surgery where the abdominal wall must be opened, exposing the peritoneal cavity. Some of these advantages include:

  • Quicker healing
  • Short hospital stay
  • Much less pain after the procedure
  • Reduced potential for developing infection
  • Smaller scars

The Risk of Spreading Cancer

Unfortunately, many types of uterine sarcoma including leoimyosarcoma (LMS) are nearly impossible to diagnose in their early stages, prior to any abdominal procedure including hysterectomy and myomectomy. Uterine leoimyosarcoma is a rare, nearly always fatal, cancer.

Grinding the tissue using power morcellators is known to spread cancerous tissue throughout the patient’s pelvis and abdomen. When the ground bits of cancerous fibroid tumor lands in the fertile tissue of the abdomen, it is provided the perfect growing environment. This is especially true for women that have undergone one of three specific morcellator procedures including:

  • Robotic hysterectomy
  • Laparoscopic supracervical hysterectomy
  • Removal of uterine fibroids (laparoscopic myomectomy)

Using a power morcellator in a minimally invasive laparoscopic procedure is known to accelerate the spreading of precancerous or cancer sarcoma cells throughout the patient’s abdomen. Recent studies indicate that any patient developing morcellation cancer has a 400 percent greater chance of dying than patients with the same cancer not having the procedure.

History of Uterine Morcellation

In the mid-1990s, Johnson & Johnson and other minimally invasive surgical device manufacturers developed, manufactured and sold morcellators in the medical marketplace. These electronic devices were thought to be revolutionary at removing dense tissue during a variety of gynecological surgeries including myomectomies and hysterectomies.

Almost since the beginning, the medical community, doctors and the surgical device manufacturers were well aware that some women developed leoimyosarcoma and other sarcomas after the procedure. The correlation between the surgery and the development of cancer was thought to occur and one woman out of every 10,000 undergoing the gynecological procedure.

However, in April 2014, the FDA (Food & Drug Administration) issued an immediate safety communication stating that the risks involved in uterine morcellation was closer to one woman out of every 386. This number was determined in an extensive study by the FDA and Columbia University from gathered information involving tens of thousands of women over the last couple of decades.

Within weeks, Johnson & Johnson, the leading manufacturer of uterine morcellators wrote a letter to customers that had purchased the device, asking the units be sent back to the company. By July 2014, the company voluntarily recalled three models of their power morcellators, suspending all further sales. Other manufacturers are considering steps to take in response to this latest finding.

The Medical Community Response

Many in the medical community are hailing the decision by the FDA to issue a warning, and manufacturers for pulling their devices from the medical marketplace. Unfortunately, many women have already died, or are suffering the severe effects of leoimyosarcoma or other uterine cancer spread in a power morcellation procedure.

Even with this recent announcement, some gynecologists and surgeons believe it is a mistake to pull the power morcellators from use. This is because some patients are not ideal candidates for open abdominal gynecological procedures, and minimally invasive laparoscopic procedures with power morcellators are their only option for treatment of uterine fibroids (myomectomy) or hysterectomy surgery.

Legal Recourse

The manufacturers of these medical devices have a duty to properly develop, manufacture, label and market morcellators that will not harm women having gynecological procedures. Many of these manufacturers have presented their morcellators as effective and safe, when they are not. Because of that, they should be held financially responsible for their failure to warn women of the dangers of morcellator spreading cancer.

In fact, the surgical device manufacturer failed to test their products properly before placing them for sale in the medical marketplace. In addition, the manufacturer only removed the dangerous product from the marketplace after a stern warning by government agencies. Often times, manufacturers are completely aware of the serious dangers and potential risks of their medical devices, but still rush them to the marketplace or fail to remove them when deemed dangerous, in an effort to bolster their profits.

In addition, doctors failed in their ability to discuss all the potential risks involved with the surgery, allowing the woman to believe she was fully informed before the procedure was performed.

The surgical device manufacturer, medical community, gynecologists and surgeons new, or should have known, that morcellation procedures are known to spread cancer. In fact, there is a variety of safer alternatives for undergoing a laparoscopic hysterectomy or myomectomy, eliminating the potential spread of undiagnosed cancer.

Numerous legally responsible parties need to be held accountable for the injury caused to women that have had a uterine gynecological procedure involving morcellation. These include the device manufacturer for not labeling the product properly, along with the doctors and hospital for not providing adequate information on the dangerous risks involved to the patient.

Because of that, personal injury attorneys that specialize in product liability medical malpractice cases are reviewing morcellation associated cancer lawsuits. Many attorneys are filing lawsuits for financial recompense for those who have suffered leoimyosarcoma or other uterine cancer as a result of a morcellation procedure. This includes victims and surviving family members filing wrongful death suits.

Any woman that underwent a myomectomy or hysterectomy through a laparoscopic procedure involving morcellation, and developed uterine cancer, should speak with an attorney. This is because a competent personal injury attorney that specializes in medical malpractice and product liability can protect her rights.

http://jama.jamanetwork.com/article.aspx?articleid=1828692

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm393689.htm

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