Maine Hernia Mesh Lawyer
Hernia repair is the most common surgical procedure performed in the United States. Each year, over one million patients undergo surgical repair of a hernia. In approximately 90% of these procedures, patients are implanted with surgical mesh. Unfortunately, many hernia mesh devices are defective and can cause serious and life-threatening complications requiring additional surgeries and other treatment.
What Does Hernia Repair Involve?
Hernias occur when organs or tissue protrude through openings or debilitated areas of muscle or connective tissue, usually in the abdominal wall. Hernia mesh is implanted to strengthen the weakened tissue and reduce the rate of hernia recurrence.
Hernia repair can be performed via laparoscopic (internally) procedure or in an open surgical procedure. Laparoscopic hernia repair is a minimally invasive procedure where small cameras are used and the hernia is repaired with only small incisions adjacent to the hernia. Open hernia repair is when an incision is made in the skin directly over the hernia.
Types of Hernia Mesh
There are three different types of hernia mesh: synthetic mesh (polypropylene or other plastic-like materials with nothing added to it), biologic mesh (mesh made from porcine, cow, or human dermis), and composite mesh (a combination of synthetic and biologic mesh).
Today, most hernia repair surgeries are performed with synthetic mesh. Synthetic hernia mesh devices are typically made from polypropylene and have a screen-like appearance.
Polypropylene is known to cause severe immunological responses in the human body which can damage surrounding tissue and result in significant pain, inflammation, and swelling. Polypropylene also has poor elasticity and a tendency to become brittle over time. Tissue and organs adjacent to the hernia mesh can become embedded or intertwined within a device leading to significant, permanent injuries.
Hernia Mesh Devices Under Investigation
Numerous hernia mesh devices are currently under investigation due to their association with significant injuries including:
- Atrium Medical: C-Qur, C-Qur Mosaic, C-Qur Edge, C-Qur TacShield, C-Qur Lite Mesh V-Patch, and C-Qur Mesh V-Patch
- Bard Davol: 3DMax, Composix, Composix E/X, Perfix Plug, SepraMesh, ST Products, Ventralex, Ventralight ST, Ventralex ST, and Ventrio ST
- Covidien: Parietene, Parietene Macroporous, Parietene Progrip, Parietex, Parietex Composite (PCO) Mesh, Parietex Progrip, Parietex Plug System, Progrip, Symbotex, and Surgipro
If you are uncertain which company manufactured your hernia mesh, call a Maine hernia mesh lawyer at Fitzgerald Law Group and we will explain the medical records that need to be collected to identify the product.
Hernia Mesh Injuries
Surgical hernia mesh has been linked to numerous serious injuries including:
- Revision Surgery: a subsequent surgery to remove the mesh which is often very painful and can lead to long hospital admissions and follow-up care.
- Bowel Obstruction: where the bowel becomes obstructed with surgical mesh resulting in severe pain, bloating, constipation, nausea or vomiting which may require surgery.
- Organ Perforation: where the mesh pokes holes in surrounding organs or tissue which can lead to significant pain and require corrective surgery.
- Infection: bacteria can infiltrate the surgical mesh and be very difficult to eradicate even with antibiotic therapy resulting in pain, warmth, inflammation and often the need to remove the mesh.
- Seroma: a fluid collection at an infected hernia mesh site which over time can harden and may require aspiration or they can develop into a painful abscess which may require surgical repair.
- Fistula: when a hernia mesh is chronically infected or migrates, a fistula can develop which can be a serious condition.
- Pain: when a hernia mesh device fails, the patient can experience constant, intense discomfort at the hernia mesh site which significantly impacts their quality of life and ability to work or perform activities of daily living.
- Adhesion: scar-like tissue that develops between a hernia mesh device and surrounding tissue or organ which can be very painful and require surgery to remove the mesh or adhesions.
- Shrinkage: when a synthetic mesh device contracts after implantation pulling ingrown tissue and/or adhered organs causing significant discomfort.
- Migration: dislocation and/or movement of the mesh from its implanted position which can lead to recurrence of the hernia, pain, fistulas, and the need for corrective surgery.
- Recurrence: when a hernia redevelops despite implantation of a surgical mesh device.
Unfortunately, some hernia mesh injuries can become so severe that they result in death or permanent disability.
Regulatory Oversight of Hernia Mesh
In October 2012, the FDA issued a warning letter to Atrium Medical Corporation indicating that the company had failed to adequately address problems with infections involving C-Qur devices including the company’s ignoring sterility problems at their manufacturing facilities. On August 9, 2013, the FDA announced a Class II recall of the C-Qur Edge hernia mesh because the omega three fatty acid coating on one side of the device was adhering to the product packaging.
In October 2014, the FDA issued a Safety Communication regarding the problems with surgical hernia mesh which stated “FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels. Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.”
In May 2016, Ethicon recalled Physiomesh from the worldwide although the company maintains that their removal of the product was not a recall.
Hernia Mesh Litigation
A growing number of hernia mesh lawsuits are being filed against various manufacturers in courts around the United States. Lawsuits involving Ethicon’s Physiomesh have been centralized in a multi-district litigation before U.S. District Court Judge Richard Story in the United States District Court for the Northern District of Georgia.
Similarly, lawsuits involving Atrium Medical’s C-Qur product line have been centralized in a multi-district litigation before U.S. District Court in the United States District Court for the District of New Hampshire. A state court consolidation of C-Qur hernia mesh cases is also proceeding in New Hampshire where Atrium Medical is headquartered.
Plaintiffs in hernia mesh cases allege that manufacturers either knew about the potential for serious complications or should have known about the risks. They also allege the companies chose to prioritize profits over patient safety by withholding information about the risks from doctors and the public. Some plaintiffs also allege that companies stopped manufacturing certain devices due to high failure rates but chose not to notify patients or physicians about the problems or the true reasons for withdrawing products from the market.
Maine Hernia Mesh Lawsuit
If you or someone you love has suffered complications from a hernia mesh device, you may be entitled to significant compensation for your injuries.
To speak with an experienced, Maine hernia mesh lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (844) 348-9529, or complete the contact form on this website for a free, confidential, case assessment.