HERNIA MESH COMPLICATIONS: HOW TO SUBMIT ADVERSE EVENT REPORTS AND WHY YOU SHOULD

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December 16, 2017
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December 16, 2017

Hernia Mesh

Hernia mesh complications can occur long after the initial hernia repair surgery. This point was highlighted in a recent study, which found that even though hernia mesh reduced the risk of having to reoperate for recurrent hernia, the benefits were eventually offset by hernia mesh complications down the road.

Complications caused by hernia mesh include:

  • • Inflammation
  • • Infection
  • • Chronic pain
  • • Hernia recurrence
  • • Adhesion
  • • Allergic reaction
  • • Fluid buildup
  • • Tissue or mesh erosion
  • • Need for additional surgeries (called revision surgeries)

How to Report Adverse Events to FDA

If you were injured by hernia mesh, it’s important to report the event to the FDA so the agency can see exactly what types of complications are occurring and with what brands.

Patients can submit adverse events through the FDA’s MedWatch database.

The FDA recommends including as much detail as possible when filing these reports. This includes information about the person who was affected, including their age, sex and ethnicity, and the product that caused the problems, including its name, manufacturer and product codes.

You can also report problems to the FDA’s Consumer Complaint Coordinators, who are assigned in every state to answer questions.

Adverse Event Reporting – Does it Help?

There are many flaws in the FDA’s adverse event reporting system, but that doesn’t mean the system is useless.

The FDA relies on these adverse event reports to make important decisions about patient safety.

This can be seen in the case of Essure, a permanent sterilization device inserted into a woman’s fallopian tubes to prevent pregnancy. The device has caused a number of serious, sometimes life-threatening side effects in tens of thousands of women nationwide.

Pile of paperwork from FDA

The FDA began scrutinizing Essure after women harmed by the device began mobilizing. They created support groups on Facebook and called on Congress members to fight for sensible federal policies that put patient safety first.

They also filled the FDA’s adverse event database with their own reports of side effects caused by Essure.

Between the time Essure was approved in 2002 and 2015, the FDA received nearly 10,000 reports of adverse events associated with Essure, including device migration, autoimmune reactions, hair loss, and pregnancy, to name just a few.

The FDA took action once patients put pressure on the agency. Though Essure isn’t off the market, like many advocates hoped, there is now a black box warning on its label. Black box warnings are the strictest warnings given by the FDA short of a recall.

Hernia mesh patients can put the same pressure on the FDA by submitting these adverse event reports themselves.

Why is it up to patients to submit their own reports?

A recent Congressional inquiry into the FDA’s reporting system found manufacturers and healthcare facilities aren’t submitting adverse event reports like they’re supposed to be, so patients are taking matters into their own hands.

FDA’s Adverse Event Reporting System has deep flaws

When a patient experiences serious complications from a medical device, such as hernia mesh, it is the duty of the healthcare facility and mesh manufacturer to report those adverse events to the U.S. Food and Drug Administration.

Healthcare facilities, which include hospitals and outpatient facilities but not doctor’s offices, are legally obligated to report adverse events whenever they become aware of information that suggests a medical device caused death or serious injury to a patient.

Manufacturers are equally obligated by law to submit these adverse event reports to the FDA.

Why?

Adverse event reports are an important indicator of medical device safety. The FDA uses these reports to monitor and track potential safety issues after a device is marketed in the U.S.

But the FDA’s adverse event reporting system has deep flaws, as highlighted by a recent U.S. Government Accountability Office report.

The adverse event reporting system relies on manufacturers and healthcare facilities to “self report.”

This means it’s up to manufacturers to report problems with their own medical devices and healthcare facilities to report problems that occur within their own facilities.

This can lead to a serious gap in the time an adverse event occurred to the time it is reported.

Manufacturers are required to report deaths or serious injuries within 30 days of becoming aware and healthcare facilities must report deaths and serious injuries within 10 working days.

These mandatory time frames are not being met in the real world.

Hospital hallway unfocused and IV focusedThe GAO report said numerous manufacturers are still not reporting adverse events within the required time frame or are not implementing medical device reporting procedures at all.

When it comes to healthcare facilities, adherence to reporting requirements may be even worse.

The FDA inspected 17 hospitals in December 2015 after several high-profile cases of device safety issues came to light and found that not only were reports of deaths and serious injuries not being submitted, some facilities didn’t even have procedures for reporting adverse events in place.

The federal agency doesn’t believe these 17 hospitals are unique either. Based on the number of healthcare facilities in the U.S. and the number of adverse event reports the FDA receives, the agency believes there is little to no reporting being done at some hospitals, according to the GAO report.

What’s worse? Hospital staff often wasn’t aware or even trained to comply with the FDA’s entire adverse event reporting requirements, the report indicated.

This is a major concern for hernia mesh patients who undergo surgery in these healthcare facilities.

If the GAO report is any indication, there’s a good chance hospitals aren’t submitting adverse event reports when a patient comes back with hernia mesh complications.

This is why it’s so important for patients to take control and submit reports themselves through MedWatch.

If manufacturers and healthcare facilities won’t, patients will.

Hernia Mesh Lawsuits

If you’ve been injured by one of the many problematic hernia mesh devices on the market, you may be entitled to financial compensation.

Hernia mesh brands causing complications include:

  • • Atrium C-Qur Hernia Mesh
  • • Bard Sepramesh
  • • Bard Ventralex ST Hernia Patch
  • • Bard 3DMAX Mesh
  • • Ethicon Physiomesh