HOW DOES A SURGICAL MESH WORK?
To lower the risk of recurrence, surgeons often use surgical mesh to strengthen the hernia repair.
Most of these devices are made from synthetic materials or processed and disinfected animal tissue. Synthetics can be knitted or non-knitted sheets. Either ones can be made to be permanent (non-absorbable) or absorbable (will degrade in time while new tissue grow).
There are situations when the surgical mesh has been defective and caused many medical complications.
The side effects and risks of having a defective hernia mesh implanted in your body are in some cases life threatening.
SIDE EFFECTS OF HERNIA SURGERY
A defective hernia mesh can unleash the following serious problems:
• hernia recurrence
• scar-like tissue that sticks tissues together (adhesion)
• blockage of the large or small intestine (obstruction)
• mesh migration
• mesh shrinkage (contraction)
• perforation or hole in neighboring tissues or organs
FDA HERNIA MESH RECALLED AND WARNINGS
The FDA recalled the Atrium C-QUR Mesh in 2009 because of issues related to its packaging and since had been slow to make recalls on the many products available to surgeons despite many cases of defective hernia mesh reported.
In January 2016, the FDA issued final orders to manufacturers and the public, strengthening the requirements for surgical mesh to repair pelvic organ prolapse (POP) trans-vaginally, or through the vagina.
The orders followed safety concerns, including severe pelvic pain and organ perforation.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health.
The FDA said it would continue monitoring women with this devices years after surgery.
One FDA order reclassified these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices.
The second order required manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
HOW TO BEGIN A HERNIA MESH LAWSUIT?
Greg Jones Law is currently taking cases involving defective hernia mesh and is available today for a free case evaluation.
Plaintiffs in this kind of lawsuits generally had a surgery to repair their hernia and had a surgical hernia mesh implanted and afterwards suffered severe and extreme side effects, including infection, bleeding, mesh shrinkage, or seroma. They experienced suffering and loss as a result.
Greg Jones Law has sued many major drug manufacturers for failing to warn of the dangers of their medical devices and has the means and experience to represent clients throughout the United States in pharmaceutical litigation.
To find out if you have a case, call 855-Jones-Law or 855-566-3752. You can also contact us online for a free, no hassle, consultation.