FDA Outlines Hernia Surgery Mesh Complications and Risks For Consumers Making Treatment Decisions

Following widespread reports involving painful complications from hernia surgery mesh, federal regulators have released a new guide that is designed to warn consumers about risks associated with the implants, and help them make an informed treatment decision before receiving surgical mesh for a hernia repair.

The U.S. Food and Drug Administration (FDA) published a guide on hernia surgery mesh complications on July 13, outlining both the benefits and risks for consumers considering a procedure to implant surgical mesh for treatment of a hernia.

In recent years, tens of thousands of hernia surgery mesh lawsuits have been filed against a number of different manufacturers, alleging that design defects associated with certain products caused the mesh to fail, leading to fistulas, infections, recurring hernias, severe and permanent injuries and complications, and often, the need for revision surgery to remove the failed implant.

C.R. Bard alone faces more than 18,000 such product liability lawsuits associated with polypropylene mesh systems, including including Bard Ventralight, Bard Ventralex, Bard 3DMax, Bard PerFix Plug, and others. Medtronic’s Covidien unit also faces more than 6,000 lawsuits filed in state and federal courts, including complications associated with products like Covidien Parietex, Covidien Symbotex and others.

Given the failure rate associated with certain products, the size and scope of the litigation is expected to increase in the coming years, as hernia mesh lawyers continue to investigate and file new claims over complications associated with the surgical products, alleging that consumers could have avoided painful and debilitating injuries if manufacturers had disclosed information about risks from surgical mesh for hernia repair.

Hernia Surgical Mesh Risks and Benefits

The FDA’s new guide for consumers on surgical mesh procedures indicates about 30% to 65% of hernias will eventually require surgical treatment. Those options include laparoscopic repair, robotic repair and open repair. Both laparoscopic and open repair can involve the use of surgical mesh.

The benefits of a hernia mesh, if designed and implanted correctly, include a reduction of the risk of a recurring hernia, decreased operative time and a faster recovery time. However, the latter depends on the type of hernia and the surgical approach as well.

Some of the common complications from hernia mesh surgery include pain, infection, hernia recurrence, scar tissue which become adhesions, bleeding, blockages, abnormal connections between organs, vessels and intestines, fluid build-up at surgical sites, known as seromas, and perforation of neighboring tissues and organs.

Hernia mesh problems can also involve migration and shrinkage of the mesh itself, which can lead to many of the above-listed complications, the FDA warns. While the agency did not address allegations raised in lawsuits, many manufacturers face claims that design decisions associated with certain products greatly increased the risk of these complications.

As part of the guid, the FDA also published a list of key questions for patients undergoing hernia repair. Before surgery, patients should be aware of what type of hernia they have, the non-surgical and surgical treatment options, the risks and side effects of surgery, what the mesh will be made of, whether it is possible to repair the hernia without the use of a surgical mesh, and the expected benefits and risks.

Patients should ask their doctors what their risk is for hernia recurrence, pain, infection, and other complications, and whether those risks would be different depending on the type of hernia mesh used.

“Be aware that a hernia recurrence is possible,” the FDA advises patients. “Be sure you know the symptoms and when to seek evaluation for recurrence.”