A woman who underwent surgery to repair a ventral hernia — bulging tissue through the abdominal wall muscles — is suing Johnson & Johnson and its subsidiary Ethicon for injuries she blames on the companies’ Proceed hernia mesh.
Ruby C. says she suffered bowel perforation, adhesion injuries and had to have additional surgery because of the “defective” Ethicon Proceed hernia mesh device.
Surgical mesh devices are implanted to provide additional support to weakened or damaged tissue. Mesh is commonly used in urogynecologic procedures, such as pelvic organ prolapse — to reinforce the weakened vaginal wall — and stress urinary incontinence — to support the urethra — as well as in hernia repair.
In the case of an abdominal hernia repair, for example, mesh is thought to be stronger than standard stitches, according to WebMD.com.
A loosely woven sheet of flexible mesh is used to patch the weak area (where the intestines bulge through the abdominal wall) or plug up the hole instead of simply stitching it, the site reports.
According to Ruby’s Ethicon Proceed hernia mesh product liability and personal injury complaint, the Pennsylvania resident had an incisional ventral hernia repair in November 2005. Nearly 10 years later, in August 2015, she required surgery for a recurrent incisional hernia repair.
During that procedure, her doctor discovered that the Ethicon Proceed hernia mesh had bonded to Ruby’s bowels, which were perforated during the two hours the doctor spent trying to separate the bowels from the hernia mesh.
As a result of the bowel perforation, Ruby had to have a resection.
Within a month, she claims to have suffered a small bowel obstruction, requiring hospitalization as well as physical and occupational therapy.
Ruby alleges that the defective design and manufacture of the Ethicon Proceed hernia mesh presents “an unreasonable risk of severe adverse reactions to the mesh or mesh components,” including:
- Chronic pain
- Recurrence of hernia
- Foreign body response
- Inadequate or failure of incorporation/ingrowth
- Deformation of the mesh
- Improper wound healing
- Excessive and chronic inflammation
- Adhesions to internal organs
- Fistula formation (the leaking of gastric fluid to other organs)
- Granulomatous response
- Seroma formation (fluid build up under the skin)
- Nerve damage
- Tissue damage and/or death
Ruby’s lawsuit is not the first sign of trouble for Ethicon, and other makers of hernia mesh devices, which are the subject of an onslaught of lawsuits. There have also been numerous mesh recalls.
In June 2016, FDA News reported that Ethicon voluntarily recalled its surgical mesh product, Physiomesh, due to higher-than-average revision rates (need for corrective procedures) after use.
After analyzing data from “two large, independent hernia registries that showed higher than average rates of recurrence after laparoscopic ventral hernia repair compared to other meshes,” Ethicon took its flexible composite mesh off the market, according to FDA News.
Hernia mesh complications reported to the FDA 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” in addition to infection, chronic pain and hernia recurrence.
If you been injured because of a defective hernia mesh product, you may be able to file a lawsuit.. Contact the attorneys at McDonald Worley for a FREE case evaluation today.