Power morcellators are devices with small whipping blades that break up large tissue masses into small fragments, which are then vacuumed away and out of the body. Gynecologists use power morcellators when they perform procedures such as a hysterectomy or a myomectomy. These electric devices give doctors an opportunity to use a technique that allows surgeons to make incisions of less than 2 centimeters in size and to be able to remove fibroids and other irritating tissue. These small incisions give doctors the ability to not have to make major incisions into the core stomach muscles which, furthermore, helps patients endure less post-operative pain and fewer wound complications as well as a quicker road to recovery.
The very word “morcellation” means to cut into smaller pieces. Recent medical evidence shows that these pieces, even when removing fibroids that are not cancerous, can be extremely detrimental. If any of these tissues contain cancer calls and they aren’t removed, they may spread to other areas, leading to the development of dangerous cancerous tumors throughout the body. Often, these devices are used in women for hysterectomies and removing benign masses (fibroids). Yet, they may also be used in laparoscopic renal (nephrectomy) or spleen (splenectomy) surgery. With these specific cases, benign or cancerous tissue can spread to the abdomen in women or men.
The dangers of spreading tissue around the body without knowing if it is cancerous or not gives the next fact a gruesome meaning. According to estimates by the U.S. Food and Drug Administration (FDA), morcellators are used in about 60,000 hysterectomy and myomectomy procedures annually. Continually, about 250,000 women each year are affected by uterine fibroids and the risk of developing the condition–also called leiomyomas–increases after age 50. By removing fibroids, doctors can relieve pain, bleeding and other uncomfortable symptoms without removing a woman’s uterus. However, while these fibroids are benign, they may also harbor undetected cancer cells. This specific type of cancer is extremely difficult to detect before surgery. Due to this notion, and knowing that power morcellators spread tissue fragments in the body, cancerous cells may spread throughout the abdominal and pelvic cavity, causing the disease to spread. Even the non-cancerous fragments can cause abnormal growths in other organs and tissues, leading to more surgery .
The FDA Warns About Laparoscopic Morcellators
To get rid of cancerous or benign tissue or tumors, surgeons typically perform two morcellation techniques including: laparoscopic and hysteroscopic procedures. Each surgery uses a specific device designated by manufacturers. Hysteroscopic morcellators are made with tissue traps or collecting pockets that capture any dismantled tissues that is then transferred to the proper doctors for testing. There has been no significant study to suggest that it increases the likelihood of cancer.
Conversely, The FDA does warn about laparoscopic procedures as it does not contain any collecting apparatus to gather the dispersed tissue. This “open morcellation” is a technique in which surgeons insert the tiny blades into a small incision made in the abdomen to then shred and remove the tissue. Still, as the “open” suggests, the exposed environment allows the tissue to spread around into the abdominal and pelvic cavity. This is where a majority of morcellators fall.
On its website, the FDA warns of two new contraindications that are recommended:
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are pre- or post-menopausal, or are candidates for en bloc tissue removal (i.e. through the vagina or mini-laparotomy incision). It’s important to note that these groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected toc contain malignancy.
Following this indication, they also warn doctors to be aware of the new boxed warning recommended by the FDA that warns about uterine tissue and how it may contain unsuspected cancer. In fact an estimated 1 out of every 350 women who undergo gynecological surgeries have undetected cancer cells within their uterine fibroids. Therefore, with the knowledge that the 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 .
Unfortunately, it was too late for many women
Cases of Affected Women
- Peggy Paduda is a Florida women who filed a claim against Karl Storz Endoscopy America, the manufacturer of the Karl Storz Rotocut Morcellator stating, “The Defendants failed to adequately warn about the true risk of dissemination and fulmination of cancer from the use of the device. Despite their knowledge of that true risk and of their own failure to adequately warn of it, they failed to make the instrument safe for its intended use, making it unsafe for that use.” Paduda underwent a hysterectomy in 2013 to remove fibroids from her uterus. As we’ve discussed, it is particularly hard to detect cancerous cells in this area. After the procedure, it was discovered that not only did she have endometrial stromal sarcoma (a rare and deadly cancer) but also the doctors found that the morcellator spread the cancer throughout her abdominal cavity, limiting her life expectancy and reducing her quality of life .
- A high profile case was filed in Philadelphia involving an anesthesiologist named Dr. Amy Reed and her husband, Dr. Hooman Noorchashm who have been battling the manufacturing company for their responsibility in Dr. Reed’s diagnosis. Reed was diagnosed with cancer in 2013 after an operation to remove her uterine fibroid tumors involved a power morcellator made by the major company Johnson & Johnson. The Wall Street Journal reported that the FBI is looking into what Johnson & Johnson knew about the device’s risks as problems were reportedly first brought to the company’s attention in 2006. While the FDA and FBI continues to investigate, Dr. Reed and her husband have waged a campaign against the manufactured device for other women. As stated in a CBSNews article, Dr. Amy Reed replied to a question that asked what she tells her six children about her condition. She stated, “Having kids forces you to be very forthcoming. You cay ‘cancer’ and they say ‘well, will it kill you?’ And you say ‘I don’t know.’”
- According to a recent morcellation cancer lawsuit, the family members of a deceased Missouri woman have filed a wrongful death power morcellation lawsuit against Ethicon, a subsidiary of Johnson & Johnson which manufactures medical devices. The suit alleges that the power morcellator spread undetected cancer cells after the device was initially used to remove the woman’s uterine fibroids. The family wants to hold large pharmaceutical and medical device companies accountable for their actions and carelessness to their consumers .
Dolman Law Group
When deciding to bring a power morcellator lawsuit upon a manufacturing giant, it is essential to have the most experienced product liability attorney on hand. Successful lawsuits may have significant awards to the victims of such negligence on behalf of pharma.
If you have suffered from a power morcellator or an injury linked to a defective medical device, you deserve full compensation for all of your injury-related losses. Lawsuits against these large companies can be very daunting and complicated and may require significant resources. These companies come stacked with large legal teams and insurance companies that work to avoid liability for any medical device injuries. That is why it is crucial for you to hire an experienced attorney. At the Dolman Law Group, we aggressively stand up for the rights of injured victims against large pharma companies. Call us today for a free evaluation of your claim and a scheduled consultation at (727) 451-6900.
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