Amanda Antell  |  July 28, 2015

Category: Legal News

Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

morcellator-surgery-tools

Inspired by numerous patients that have reported suffering and complications from medical devices such as the power morcellator, the House of Representatives recently passed an amendment to a medical research bill.  This new amendment includes a provision that will require stricter safety standards and heavy monitoring of medical devices, including the power morcellator.

Supporters of the bill state that this policy will require electronic medical records to include the make and model numbers of medical devices used in treatment so the patient’s progress can be accurately recorded. Currently, this specific medical device information is not required and is often not noted in electronic medical records, which makes it difficult to achieve an adequate safety level for the patient.

This amendment is a part of a set of proposed policies called the “21st Century Cures Bill”, meant to increase federal funding for medical research and apply stricter standards to drug approval. As of yet, there is no similar bill to address these issues, with the chairman of Senate of Health and Education Committee, Senator Lamar Alexander, stating that this bill is greatly needed.

He and other supporters are hoping that a measure will pass through this panel by the end of this year and then to the Senate floor in the year following; it is unknown how similar in nature that the current bill and the Senator’s future bill may be.

Despite the support the bill is receiving, there has been just as much criticism surrounding the policy as well. Those in opposition of this bill claim the problems with the power morcellator and other medical devices lies in the specific manufacturing and design defects of the product, rather than the safety regulations and pre-clinical studies imposed by the FDA.

While the FDA has yet to comment on this bill, experts believe that this bill will place immense pressure on the FDA to revise their safety standards and practices when it comes to power morcellator devices.

While the FDA did issue a new regulation in 2013 requiring companies to include unique device identifiers that would eventually phase in through the whole system over the course of several years, the FDA is still expected to face pressure.

It is currently unknown how big of an impact this amendment will make, but supporters are optimistic that this will increase safety for patients and stricter regulations for manufacturing companies. In particular, supporters are hopeful that this new amendment will prevent future cases of uterine cancer, for women who underwent surgery where a power morcellator device was used.

Power Morcellator Complications

While power morcellator devices are incredibly convenient surgical tools, there has been controversy over the devices due to a major design flaw of the product’s cutting blades. Most commonly, this device is used to remove uterine fibroids in laparoscopic procedures, and is generally considered less invasive and intense than traditional surgery.

Unfortunately, the cutting blades slicing up the uterine fibroids have been reported to rupture undiscovered uterine sarcoma and ultimately release cancer cells inside the patient’s body. There is currently no way to diagnose uterine sarcoma before surgery, but surgeons have found success in putting surgical bags around the device to catch the debris during the surgery.

Since the release of power morcellators 24 years ago, the FDA has cleared at least 10 of these devices for the market. However, critics claim that according to morcellator applications and reviews there are indications that the FDA may have known about the risk of uterine sarcoma but chose to ignore it, at least until the issue started gaining traction in 2013.

The FDA responded to this criticism by stating that their tentative approach to power morcellator approval had ensured a good balance between innovation and safety.

Last year, an FDA warning was issued that one in 350 women is at risk of developing uterine cancer after going under a power morcellator procedure. To address this morcellation risk, the FDA called for a black-box warning for power morcellator devices, discouraging medical experts and hospitals from recommending or using it during laparoscopic surgery.

The largest power morcellator manufacturer, Johnson & Johnson, recalled their power morcellator device from the market in July 2014.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

Learn More

We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.


Get Help – It’s Free

Join a Free Morcellation Cancer Class Action Lawsuit Investigation

If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

Oops! We could not locate your form.

Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.