Medical Device Bill Calls For Mandatory Reporting of Adverse Events

Recently proposed legislation would make it mandatory for doctors to report adverse events that may be caused by the use of medical devices, coming in the wake of recent concerns about serious health risks associated with products that have been on the market for years, including Essure birth control implants and power morcellators used during laparoscopic hysterectomy procedures. 

On June 8, U.S. House Representatives Mike Fitzpatrick, a Pennsylvania Republican, and Louise Slaughter, a New York Democrat, introduced the “Medical Device Guardian’s Act“, which would require doctors and hospitals to report when patients suffer an adverse event due to a medical device. The bill would also protect those doctors from liability when submitting such reports.

Currently, reporting adverse events linked to medical devices and medications is voluntary, and some experts estimate that only 10% of such problems and complications are currently reported by doctors, hospitals and manufacturers combined, making it much harder for regulators and the medical community to identify risks associated with widely used medical devices that are on the market.

Fitzpatrick, the bill’s sponsor, told House members in comments on June 8 that the legislation was inspired by the events surrounding recent concerns over morcellators, which were widely used over the past decade to provide a minimally invasive option for women undergoing a hysterectomy or uterine fibroid removal. However, the devices have largely been abandoned by the medical community over the past few years, after it was discovered that they pose an unreasonable risk of spreading undiagnosed cancer throughout the abdomen, greatly reducing life expectancy and overall quality of life for women.

Fitzpatrick has been a vocal critic of morcellators, and how the discovery that they could spread cancer was handled by the FDA, the pharmaceutical industry and hospitals.

In December, Rep. Fitzpatrick urged the FDA to conduct a criminal investigation into how certain hospitals, like Brigham and Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center, used laparoscopic power morcellators and whether they adequately warned women about the potential risks.

The agency responded in late March, acknowledging his request, but saying that they could not reveal whether there was a criminal investigation currently proceeding against those, or any other, medical facilities.

Morcellator Cancer Lawsuits

The legislation comes amid a growing number of laparoscopic hysterectomy cancer lawsuits being pursued against Ethicon, Karl Storz and other manufacturers of power morcellators, alleging that women and the medical community were not adequately warned about the potential risks associated with electing the minimally invasive procedure.

The litigation emerged after the FDA first highlighted concerns about the link between uterine morcellation and cancer in early 2014.

After concluding that there is no way to make the devices safe for women, Johnson & Johson’s Ethicon unit issued a morcellator recall in July 2014, and announced that they would no longer manufacturer or sell the devices. The company controlled about three quarters of the power morcellator market. A number of other manufacturers still sell the devices despite the FDA warnings.

Since October 2015, all Ethicon morcellator lawsuits filed throughout the federal court system have been consolidated as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas. Earlier this month it was announced that a settlement had been reached that would resolve most of those cases.

Essure Implant Concerns

The legislation also comes amid growing concerns over risks with Essure birth control implants, another widely used medical device that Fitzpatrick has expressed concerns about.

Essure is a permanent form of birth control offered as an outpatient procedure, where the doctor inserts bendable coils into the Fallopian tubes. This process causes scar tissue to form around the coils over several months, which is supposed to block the tubes and prevent pregnancy.

Over the past few years, there have been mounting concerns about the safety of Essure procedures, with thousands of women submitting adverse event reports to the FDA involving painful and debilitating complications where the device migrated out of position, perforated the Fallopian tubes, caused allergic reactions or other problems.

Between the date the birth control product was approved in November 2002 and May 31, 2015, the FDA has confirmed that at least 5,093 adverse events have been submitted involving Essure complications.

Fitzpatrick has spoken out numerous times regarding the Essure procedure, and in November 2015 introduced the E-Free Act, which would remove the Bayer birth control device’s FDA approval.

Throughout the United States, hundreds of women are now pursuing Essure injury lawsuits, alleging that Bayer failed to adequately research the device or warn about the potential risks with the birth control implant.

An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.