Hernia Mesh Recalls and FDA News
If you underwent surgery to repair a hernia using surgical mesh and have developed postoperative injuries, you might be eligible to file a lawsuit against the mesh manufacturer. The attorneys at Stern Law can investigate your claim to help you understand your options.
A hernia occurs when internal organs, most often the intestines, protrude through a weakened wall of muscle or tissue. One of the ways doctors repair hernias is through use of surgical mesh. The mesh is usually made of synthetic polypropylene or polyester material and is used to reinforce the weakened muscle or tissue wall while pushing the protruding organs back into place.
Numerous mesh products have been approved for hernia repair, and only a few have been recalled or withdrawn from the market.
The Ventralex™ ST patch is manufactured by Davol Inc., a subsidiary of C.R. Bard, Inc., and is a round patch of polypropylene monofilament fibers that have been woven into mesh. Doctors use Ventralex™ ST patches for intraabdominal repair of umbilical, epigastric, and other small ventral hernias.
In 2011, Davol issued a voluntary recall of the product because of mislabeling. The Ventralex™ patches come in several sizes, and Davol found out that a batch of its medium-sized patches had been packaged in pre-printed cartons for its small-sized patches. Davol corrected the problem and placed the product back into the market.
Physiomesh™ is a composite mesh knitted from polypropylene and polydioxanone fibers. It is manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson, for repair of ventral hernias.
In May 2016, Ethicon voluntarily pulled Physiomesh™ from the market, after data from two studies showed a high rate of hernia recurrence and repeat surgery, compared to other hernia treatment products. In carrying out this withdrawal, Ethicon issued an Urgent Field Safety Notice to medical facilities nationwide, notifying doctors of Physiomesh™ complications and the related product recall.
Composix Kugel™ hernia patches are manufactured by Davol. They are round pieces of mesh woven from monofilament polypropylene and designed for repair of most hernias.
In 2005 through 2007, Davol voluntarily recalled various lots of its Kugel™ patches after finding out that the recoil rings around the patches were prone to breaking or buckling, causing several painful complications to patients. In doing so, Davol issued notices to doctors and hospitals informing them of the possible complications and need to discontinue use of the products.
Contact Stern Law, PLLC
At Stern Law, PLLC, we know how your medical device injuries have affected your life. Our experienced attorneys can secure the compensation you deserve, starting with a confidential consultation at no cost to you. Contact our office today by calling (844) 808-7529, and schedule your free consultation with a skilled product liability attorney.