Published on:

The Morcellation Controversy

Cancer scanThe recent recall of power morcellators used in gynecology has only heightened the controversy over the best procedures for treating uterine fibroids and performing hysterectomies. Morcellators are used in minimally invasive approaches for myomectomies and hysterectomies to decrease recovery time and reduce the chance of infection. However, studies indicate that morcellation produces significant negative consequences to the patient.

When the electric morcellation devices were first manufactured in the mid-1990s, they were considered a breakthrough in medical technology. Using a rotating blade, the narrow device can be easily inserted through a small incision to grind dense fibroid tumors into tiny fragments, before being suctioned out. As a result, many manufacturers joined the cause and brought their own versions of surgical morcellators to the medical marketplace. Some of these manufacturers include:

  • Johnson & Johnson
  • Smith & Nephew
  • Blue Endo
  • Nouvag
  • Ethicon of FemRX
  • Richard Wolf
  • Lumenis, Ltd.
  • LiNA
  • Cook Urological
  • Olympus
  • Karl Storz

Hysterectomies and Myomectomies

Uterine fibroids (leiomyomata) tend to be common among women, and often present no symptoms. However, some women do experience significant problems with their fibroids, including infertility, severe pelvic pain and/or pressure or excessive uterine bleeding.

Women often experience two specific types of uterine sarcoma: aggressive, life-threatening leiomyosarcoma and endometrial stromal sarcoma. While endometrial sarcoma can cause significant issues, the leiomyosarcoma when left untreated can be deadly if allowed to spread.

The area surrounding a woman’s uterus offers the perfect fertile environment for cancerous tissue to grow. Known as upstaging, any cancerous cell that makes its way into this fertile environment can easily take over, causing a deadly catastrophe. Advancing stages of leiomyosarcoma can metastasize to the bones, lungs, bladder, rectum, liver, or other distant organs.

Typically, gynecologists will recommend uterine fibroid removal through a partial or full hysterectomy, or by a myomectomy procedure. The technology surrounding traditional minimally invasive gynecological surgery (MIGS) has advanced over the last few decades, were skilled surgeons using laparoscopic tools can excise very large fibroids in and on the uterus. MIGS offer significant advantages to the patient that includes:

  • Minimal pain during and after the procedure
  • Fast healing time
  • Easier recovery from surgery
  • Very small incisions
  • A much lower potential risk of developing infections at the incision site
  • Easier ability for the patient to resume full activities

The U.S. National Institutes of Health (NIH) state that most American women will have uterine fibroids, either permanently or temporarily, during her lifetime. In most incidences, the fibroids are benign, and pose no significant health problems. For these women, the tumors can simply be left untreated.

Big Concerns about Morcellation

Recent studies are indicating that women suffering from leiomyosarcoma, a rare form of deadly cancer, have a significantly better survival rate when fibroids are excised using traditional methods. This is because minimally invasive laparoscopic hysterectomies and myomectomies involving morcellation tend to spread previously undiagnosed uterine cancers throughout a woman’s abdomen during the procedure.

Surgeons that specialize in laparoscopic techniques have often chosen an open power morcellation approach when dealing with fibroid tumors. They often elect to perform laparoscopic surgery using a morcellator to remove a fibroid-laden uterus during a hysterectomy procedure, or grind away fibroids in a myomectomy.

Unfortunately, open power morcellation approaches usually create significant consequences when the power device spreads tiny bits of cancerous tissue during the procedure. Cancerous cells that were contained inside the fibroid tumor can be spread in the peritoneal cavity, creating the potential of a deadly outcome postoperatively.

A recently published report by JAMA (The Journal of American Medical Association) makes claims that the potential risk of cancer spreading through morcellation has been greatly understated over the last two decades. The report outlines a study performed by Columbia University and the Food & Drug Administration (FDA), from information gathered from tens of thousands of women.

While the rate of cancer spreading from morcellation in a hysterectomy or myomectomy was thought to be one woman out of 10,000, more accurate data tends to reflect numbers of one in 386. This surprising find has made some minimally invasive surgical device manufacturers, including Johnson & Johnson, recall their devices and stop all sales of their morcellator products.

A Proponent’s Point of View

There are numerous proponents of the minimally invasive surgical procedure using morcellation in a partial or full hysterectomy, or myomectomy procedure. It is the belief of many surgeons and gynecologists that some women are not viable candidates to traditional uterine fibroid removal, and as such, need to be offered a MIGS alternative. Denying the woman minimally invasive gynecological surgery using morcellation to treat her uterine fibers goes against the physician’s Hippocratic oath to assist the patient in a treatment that works.

Alternative Approaches

While the minimally invasive laparoscopic surgery using a morcellation device provides significant benefits, its potential downside calls for alternative approaches. Women suffering severe problems with uterine fibroids have a variety of options for treatment. Some of these include:

  • Vaginal Hysterectomy
  • Abdominal Hysterectomy
  • Colpotomy Incision
  • Mini-Laparotomy
  • Drug Therapies

An End to the Controversy

When the potential risk of spreading undetected cancer throughout the peritoneal cavity through morcellation was thought to be small, the procedure was considered safe. However, with recently published numbers claiming the risk to be substantially higher, it is essential to stop the minimally invasive laparoscopic procedures involving a morcellator immediately.

The recent voluntary recalls of the surgical device might just put an end to the controversy. However, there may be better ways to perform the procedure that are significantly safer for the patient.

A major advancement in treating uterine fibroids might include medical advancements in imaging, which would permit identifying uterine leiomyosarcoma before a myomectomy or hysterectomy involving open power morcellation.

An additional advance would be the development of an enclosed power morcellation approach, which uses a bag to capture the ground tissue for removal through the incised laparoscopic port. Encapsulating the tissue in a bag during morcellation could significantly reduce the potential risk of spreading cancerous tissue throughout the patient’s peritoneal cavity.

Informed Consent

Many women were not properly informed during the process of surgical consent concerning the information about cancer cell spreading through morcellation. Because there is no accurate test available to detect or diagnose leiomyosarcoma or other uterine cancer prior to the procedure, it is essential that the risk of cancer spreading be discussed with the patient prior to her giving an informed consent.

Taking Legal Action

For the high number of women that are suffering with uterine cancer including leiomyosarcoma caused by morcellation, the controversy has been settled. The women dealing with the consequences of morcellation are taking legal action. For many clients, it is important to hold the surgical device manufacturer and physician accountable for their negligence. This is because for decades, the medical community and morcellator manufacturers have known of the potential risks of spreading cancer with the device.

Personal injury attorneys that specialize in product liability and medical malpractice are reviewing cases where laparoscopic procedures using morcellation have spread cancer in the abdomen and pelvis of women. As a result of their investigation, attorneys are filing lawsuits on behalf of their clients to protect the victim’s rights and seek financial recompense for their diminished quality of life, pain, suffering and extensive damages.

Unfortunately, the survival rate of women with stage IV leiomyosarcoma is less than five years. Because of that, many surviving families are filing morcellator wrongful death lawsuits. Most attorneys handling morcellation lawsuits for victims take the case on contingency, meaning no upfront fees are required.

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

http://newsroom.cumc.columbia.edu/blog/2014/07/22/study-examines-presence-uterine-cancers-among-women-time-hysterectomy-using-morcellation/

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm

http://online.wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350

http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=50