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The unexpected need for additional hernia surgery has prompted a Vermont woman to file a lawsuit against Atrium, the maker of the C-QUR hernia mesh implant.
Hernia mesh implants have been targeted in numerous adverse event reports filed with the FDA, claiming severe pain and side effects like the need for additional hernia surgery.
According to the lawsuit, plaintiff Jo Ann R. suffered both physically and emotionally after being implanted with the C-QUR hernia mesh, only to be required to have additional hernia surgery later.
Patients experiencing hernia problems are informed that the hernia mesh implant repair would give them relief, but many discover that due to the make of the product, additional hernia repair surgery would be required at a later date.
Those patients, like Jo Ann, who had to go through additional hernia surgery say they were never told about the defective issues in the product that ultimately caused severe injury and pain. Many of those patients say that problems such as device breakdown and migration caused unexplained pain.
Additional Hernia Surgery Required for Many Implant Patients
Once doctors discover issues associated with C-QUR products and other forms of allegedly defective hernia mesh, additional hernia repair surgery may be required. In some of those cases, however, patients experienced further complications and side effects due to the makeup of the hernia mesh implant.
The need for additional hernia surgery is just one example of the painful side effects experienced by patients who thought their hernia repair would make them better. In fact, the full list of serious side effects reported to the FDA includes chronic inflammation, nerve damage, allergic reaction, improper healing of wounds, seroma formation, failure of incorporation and refection, foreign body response, tissue damage, and infection.
Many of the problems alleged with the C-QUR product have to do with the materials used to make the mesh.
An Omega 3 coating was put on the C-QUR hernia mesh originally.
The purpose of this adhesion, according to device developers, was to minimize inflammation and to facilitate incorporation of the mesh into the patient’s body.
However, in most patients, including those who had to go through multiple surgeries, an intense inflammatory and foreign body response was recorded.
Many of these patients experienced problems on a day-to-day basis because of the body’s reaction to the mesh, but also encountered problems because of the makeup of the mesh.
When further repair surgery was scheduled to remove the mesh, for example, if the device had become adhered to nearby tissue, it made safe removal nearly impossible. This, according to the hernia repair injury lawsuit against Atrium, says that patients faced an unreasonable risk of severe adverse reactions due to recurrence of hernia, chronic pain, and more.
Many of these patients have come forward in a lawsuit to hold the manufacturer accountable because neither they nor their doctors were told about the risk for additional hernia surgery or the myriad of other serious side effects currently affecting patients. Device manufacturers have a responsibility to properly test all products and to warn patients about the risks associated with a device.
The lawsuit says that manufacturers never told the public or the medical community about the dangers of the mesh implant.
The Additional Hernia Surgery Lawsuit is In re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation, MDL No. 2753, in the U.S. District Court for the District of New Hampshire.
If you have been injured due to a hernia mesh product, speak with the lawyers at McDonald Worley today to discuss your next steps.
Note: McDonald Worley is not representing the plaintiff in this lawsuit.