New Device for Morcellator Surgeries Approved but Not Proven

On Thursday, April 7, 2016, the FDA allowed a new device onto market that claims to contain tissue during power morcellator procedures. The device, PneumoLiner, is not proven to reduce the risk of spreading cancer. The uterine cancer lawyers at Pintas & Mullins Law Firm shed light on this new device and its risks below.

Morcellator Background

Power morcellators were commonly used during hysterectomies or to remove uterine fibroids until 2014, when outcry from patient advocates and medical experts came to a head. After several studies were published officially linking power morcellators to the spread or uterine cancer, the FDA took steps to warn patients and doctors and limit the risk of aggressive cancer spread.

In November 2014, the FDA ordered new black box warnings for power morcellators and urged doctors to inform their patients that these devices could spread undetected cancer. About one in 350 women who undergo hysterectomies or myomectomies (uterine fibroid removal) have undetected uterine cancer tissue. If morcellation is performed on these women, it could spread the cancerous tissue in the abdomen and pelvis, significantly worsening their likelihood of long-term survival.

Leiomyosarcoma resembles uterine fibroids but is in fact an extremely aggressive form of uterine cancer, with a cure rate of only 75% even if caught early. Once leiomyosarcoma spreads, survival diminishes substantially. There is no reliable method for detecting cancer in uterine tissue to date.

The Reaction

In summer 2014, Johnson & Johnson (J&J) and two other companies pulled their power morcellators from global markets. Major hospitals like Massachusetts General paused power morcellator use, and insurers like UnitedHealth have tightened rules on morcellation procedures, requiring doctors to obtain specific authorization. The largest hospital chain in the country, HCA Holdings, also banned power morcellator use in uterine fibroid surgeries in all of its 178 facilities.

There has also been political pressure. Several U.S. senators have urged the FDA to pull all morcellators from market. Senators drafted their letter to the FDA after July 2014 public hearings on this issue. During that two-day meeting, several members of the public told their stories of loss and devastation caused by aggressive uterine cancer from morcellation.

Morcellator Lawsuit News

Lawsuits have been filed in state courts throughout the country against J&J and other morcellator manufacturers. Estimations range, but J&J alone is likely facing more than 5,000 uterine cancer claims. LiNA Medical recently settled with a widower who lost his wife to uterine cancer less than one year after she underwent a hysterectomy using a power morcellator. Neither she nor her doctors knew of the cancerous tissue in her uterus.

The 53-year-old widower filed suit against LiNA in 2014 and was expected to go to trial in 2015. LiNA decided to settle in an undisclosed amount. The company is facing at least 20 other similar uterine cancer claims.

PneumoLiner

The PneumoLiner is intended to isolate and contain morcellated tissue in the body, so that if there are undetected cancer cells, they are less likely to spread. The device should only be used in a certain subset of women, such as pre-menopausal women and those undergoing hysterectomies without fibroid removal. The device has not been proven to reduce the risk of spreading cancer during morcellation, however.

The chief scientist at the FDA’s Center for Devices and Radioloigical health stated that the PneumoLiner “does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”

There are risks associated with the PneumoLiner. Among these include injury to surrounding organs, infections, and spread of morcellated tissue. Only doctors who successfully complete a validated training program may use the device. It is always important to remember that patients must be fully informed of all the risks and benefits of a procedure – as well as the alternatives – before agreeing to it. Websites like ProPublica can offer patients in-depth analysis of hospitals and even specific doctors.

ProPublica’s Dollars for Docs application, for example, show which doctors received payments (and how much) from Big Pharma and medical device companies. The public can search through this database by state, hospital, doctor, or company. Medical companies are required by law to release details of their payments to doctors and hospitals. In 2014, these companies paid nearly 3.5 billion to doctors for promotional talks, consulting, and other unclear roles.

If you or someone you love was recently diagnosed with uterine cancer after undergoing a hysterectomy or uterine fibroid procedure, contact our firm immediately. You may be entitled to compensation for your medical bills, lost earnings, and mental anguish. Our team of compassionate defective medical device attorneys offers free consultations and accepts clients nationwide.

Categories

Free Consultation
  • Please enter your first name.
  • Please enter your last name.
  • Please enter your email.
    This isn't a valid email address.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please make a selection.
  • Please make a selection.
  • Please enter your message.