Legal Helpline Hernia Mesh
Hernia repair surgery is one of the most commonly performed surgeries each year. Commonly, surgeons use mesh to provide additional support to weakened or damaged tissue. The majority of mesh used is synthetic or made from animal tissue.
However, this mesh is often associated with numerous complications, including infection, wound reopening, chronic pain, bowel obstruction, and required revision or repair surgery.
What is a Hernia?
A hernia occurs when an organ or fatty tissue squeezes through a gap in the muscular wall or a weak spot in the surrounding muscle or connective tissue, called fascia. Hernias often occur in the abdominal wall, as well as the groin.
Surgery is the only option to repair hernias. Because hernias have a high rate of recurrence, surgeons may use surgical mesh to fortify the weakened or damaged tissue, which may or may not be successful.
Adverse Events Following Hernia Repair with Mesh
Repair with surgical mesh may result in various complications, known as adverse events. The most common adverse events include:
- Hernia recurrence
- Bowel obstruction
Additional potential adverse events include mesh migration and shrinkage. Complications may require surgical repair or revision.
Fast-Track Approval Process
Hernia mesh manufacturers used the FDA’s 510(k) clearance process to fast-track approvals of devices that are similar to existing devices on the market without pre-market approval. As a result, thousands of defective surgical hernia mesh products have been implanted in patients, leading to serious complications, and required removal or revision surgeries.
Hernia Mesh Recalls and Market Withdrawals
From 2010 through February 2019, hernia mesh manufacturers recalled a substantial number of devices. Most of these recalls were classified as Type II recalls by the FDA, meaning the device can cause a temporary or medically-reversible complication.
Johnson & Johnson’s Ethicon unit issued a market withdrawal of surgical mesh devices. C.R. Bard and Atrium have also recalled mesh devices.
The FDA classified C.R. Bard’s Kugel Patch as a Class I recall, the most serious type of recall, meaning the recalled product could cause serious health consequences or death.
Hernia Mesh Lawsuits
Several current lawsuits have been consolidated in multidistrict litigations (MDLs), including Ethicon, Atrium, and C.R, Bard. If you or a loved one suffered hernia mesh injuries, contact Legal Helpline for a free case review, or visit herniameshlegalgroup.com for more information.