Approximately one million Americans have hernia repair surgery each year. Nearly 800,000 of these repairs are for inguinal (inner groin) hernias. Hernia or surgical mesh has been used since the 1980s. By the year 2000, 90 percent of hernia repairs used either synthetic or animal-derived mesh.
Although some patients tolerated hernia mesh and reported no adverse effects, many others had complications that ranged from discomfort to life-threatening. In December of 2005, the U.S. Food and Drug Administration (FDA) issued the first of several recalls for hernia mesh devices made in America and abroad.
FDA Recalls Six Hernia Mesh Devices in 2005
After receiving many reports of serious complications including death, the FDA issued a recall for six hernia mesh products. The agency classified this recall as a “Class 1”, a designation used by the FDA for “dangerous or defective products that predictably could cause serious health problems or death”.
The six recalled hernia mesh devices in the 2005 recall were made by the C.R. Bard company and distributed through its subsidiary, Davol, Inc. in Rhode Island. The FDA recalled the mesh after discovering that its memory recoil ring could break and potentially lead to bowel perforation or chronic bleeding.
Later Mandatory and Voluntary Hernia Mesh Recalls
More hernia mesh devices were recalled in the 13-year period between 2005 and 2018. Some products were recalled by the FDA following a voluntary recall by the manufacturer. Many of these are open recalls, meaning that are ongoing.
2010 Recall of Ethicon Hernia Mesh Devices
In October of 2010, the FDA issued another recall for surgical mesh made by Ethicon, Inc., a New Jersey-based company owned by Johnson & Johnson. Ethicon's polymeric surgical mesh called Proceed was taken off the market because it dissolved into layers inside patients.
That same year, the FDA issued a Class I recall and safety investigation of counterfeit surgical mesh. Four hernia mesh products were recalled when the FDA discovered that they were counterfeit products stamped with C.R. Bard product codes. The fake hernia mesh was not made from approved material and in some instances, was not even sterilized.
RAM Medical, Inc. sold the counterfeit products to six medical distributors. The distributors, in turn, sold them to hospitals and surgery centers. The FDA urged both patients and doctors to check for matching product codes of the recalled devices.
More Hernia Mesh Recalls in 2013
The FDA recalled polymeric hernia mesh devices made from Atrium Medical Corporation. The devices were recalled after reports that the coated mesh did not perform well when exposed to high humidity.
Johnson & Johnson Voluntarily Recalls More Hernia Mesh in 2016
Once again, hernia mesh products made by Johnson & Johnson subsidiary Ethicon, Inc. had to be recalled. This time, the recall was voluntary and concerned products containing Physiomesh flexible composite mesh. Patients had a higher rate than normal of hernia recurrence using the defective mesh.
Two Hernia Mesh Recalls in 2018
On February 23, 2018, the FDA issued a recall for hernia mesh made by a French company called Sofradim Products. The company's Versatex monofilament mesh were found to be unsafe because of an abnormal number of hernia recurrence. Patients who had the recalled Versatex mesh were forced to have additional surgery.
The FDA issued another recall that same day for the ProLite mesh made by Atrium Medical Corporation. Although this second recall for Atrium hernia mesh ended in July of 2018, the agency believed there was an “undetermined” risk for patients.
What You Should Do if You Believe You Have a Recalled Hernia Mesh
Your hernia mesh product code may or may not match the products listed on the FDA recall web pages. If you have any of the following symptoms of hernia mesh failure, seek medical attention right away:
- Fever, chills, malaise, and other flu-like symptoms
- Nausea, vomiting, and inability to pass gas or have bowel movements
- Bloody or pus-filled discharge
- Recurrence of hernia
- Pain in and around the surgical site
- Swelling and tenderness at the surgical site
- Skin at surgical site is warm to touch
People with defective hernia mesh typically need more surgery. This means additional medical bills, lost wages, and needless pain and suffering.
Our Firm Accepts Defective Hernia Mesh Cases
You may be entitled to compensation if your hernia repair surgery involved defective hernia mesh. Our firm can help find out if you qualify for compensation. We are a mass tort product liability law firm who works on a contingency basis. For a free, no-obligation consultation, please click here or call Tosi & Rose at 888-311-8292.