In the 1990’s, doctors wanted to perform less invasive surgeries, especially in the area of gynecology. However when surgeons needed to perform a minimally invasive hysterectomy or to treat a woman whose uterus was filled with uterine fibroids, laparoscopic surgery proved to be difficult. Enter the surgical device known as the called laparoscopic power morcellator that made such surgeries far easier for doctors.
Fast forward 20 years to 2014. The FDA had found through various avenues of research and complaints from consumers that there was a growing body of evidence that suggested that power morcellators were likely responsible for many uterine cancers. The federal agency issued a strong warning against the device and touched off a firestorm of controversy and litigation surrounding power morcellators.
An article by the WSJ talks about why these dangerous devices were used in the first place.
1. Power morcellators offered doctors & patients the option of a less-invasive surgery.
A power morcellator is tube-shaped with a motorized blade that is inserted into a small incision in the abdomen of a woman. Many women opted for the surgery using the new tool because it left smaller scars and faster recovery time. It was also much easier for the doctor. Manual morcellation takes a long time.
2. Power morcellators exposed patients to dangers that had not been considered.
A study conducted in South Korea and presented at a medical conference in 2011, brought up concerns about how morcellation using these devices could spread tumors. Surgeons had noted in the past that the devices could leave tissue behind and spread it around. The raised the concern that power morcellators were possibly lessening the chance of survival for women with uterine cancers by spreading it throughout the body.
3. Several years later, the public is made aware of issues surrounding power morcellators.
In the latter part of 2013, the story of Amy Reed made headlines. In the well-publicized case, Boston’s Brigham and Women’s Hospital said that, by using a power morcellator, it inadvertently worsened the cancer of Dr. Reed. She, along with her husband, who was also a doctor, wanted to make the public aware of the problem.
The FDA, in a surprising move in 2014, advised doctors to not use power morcellators. The agency released a figure that stated approximately 1 in 350 women who after undergoing the surgery involving power morcellators had a cancerous tumor that looked like a fibroid. Such growths, according to the federal agency, could not be reliably detected before surgery.
The largest manufacturer of power morcellators, Johnson & Johnson, almost immediately ceased sales worldwide and shortly thereafter completely withdrew the devices from the market. In the last quarter of 2014, the FDA called for manufacturers to place a “black-box” warning on the device.
4. Warnings issued by the FDA show a shift in surgical procedures
Although the black box waring is the most severe warning that the FDA issues, the agency did not place a ban on the device. According to the FDA, not banning power morcellators left the option open for women who felt that the benefit of surgery using the tool was worth the potential health risk. However, the FDA stood by the assertion that all women should be warned prior to surgery of the chance of the spread of undetected cancer should a power morcellator be used for the procedure.
However, these warnings have caused gynecologists to perform hysterectomies and the removal of uterine fibroids differently. The American Congress of Obstetricians and Gynecologists has now recommended that for women requiring a hysterectomy, a vaginal procedure should be performed as it offers the best outcome with fewer potential complications after surgery.
5. Power Morcellators and the risks connected to them are still being considered in the courts.
The matter has now come before courts across the country. Congress has requested that the Government Accountability Office investigate why power morcellators were on the market for two decades before the Food and Drug Administration released a warning about the potential of the devices spreading uterine cancer.
FDA said in a statement that, “its “primary concern is the safety and well-being of patients” and that they were,” notified by the GAO of its investigation and plans to fully cooperate with the review.”
If you or a loved one has undergone surgery where a power morcellator was used, you could be facing a serious health crisis as a result. You may have even had to agonizingly watch a loved one lose their battle with cancer; which may have been prevented if doctors had not used the medical device.
If this describes your situation, it is possible that you may be entitled to financial recovery. Such an award may go a long way to help pay for any medical bills, cancer treatments, lost work as well as pain and suffering or even wrongful death. To find out, call the law offices of John Foy & Associates to schedule a free consultation regarding your power morcellator case.