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Surgical Mesh Lawsuit to Proceed

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Providence, RIA Rhode Island man who received recalled abdominal mesh just prior to a product recall in 2005, will see his surgical mesh lawsuit go forward after a Rhode Island judge refused to dismiss the case.

According to court documents Wayne Smith received the Composix Kugel Hernia patch abdominal mesh for repair of a ventral hernia. Not long after surgery, according to documents, the plaintiff began experiencing severe abdominal pain, together with tenderness at the surgical site.

As it turned out, the manufacturer of the abdominal mesh product, Davol Inc. (a subsidiary of C.R. Bard), triggered a series of recalls for its Composix Kugel mesh due to problems with the so-called ‘memory ring’ used to deploy the patch inside the body by way of minimally-invasive surgery. Following several reports of the memory ring, which was made of plastic, splintering and migrating away from the surgical site – along with reports of intestinal fistulae, bowel perforation and in some cases, death – Davol recalled the mesh.

The recall was classified, in December 2005 as a Class 1 recall, the highest level of recall observed by the US Food and Drug Administration (FDA), given the risk of serious surgical mesh complications.

Plaintiff Wayne Smith consulted his surgeon, who recommended the abdominal patch be removed. The explantation would have involved a second surgical procedure, within close proximity to the first.

Smith subsequently filed a surgical mesh lawsuit against defendants Davol and C.R. Bard in Providence Superior Court citing violation of the Rhode Island Deceptive Trade Practices Act, strict product liability, negligent and intentional infliction of emotional distress, breach of warranty and failure to warn. 

Smith’s mesh lawsuit further asserted that the abdominal mesh was defective at the point when it left Davol’s immediate control, as well as a claim that the mesh posed a serious threat to the consumer.

Davol and C.R. Bard attempted to have the abdominal mesh lawsuit dismissed, asserting that Smith’s claims failed to satisfy Rhode Island law. The judge in the case, Alice B. Gibney disagreed with the defendants, noting that in her view the plaintiff’s claims satisfied Rhode Island law, and that there were sufficient grounds to support an allegation that a defect was the proximate cause of the man’s injury.

Judge Gibney issued her surgical mesh complications ruling November 28.

The lawsuit is Wayne Smith, et al. v. Davol Inc., et al., Case No. PC-08-8307, in Rhode Island Superior Court, Providence.

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READER COMMENTS

Posted by

on
Synthetic surgical mesh is a serious problem and I've been putting together a website to provide some information, but more important to gather information and bring this to the public. Of note, we've put two things on this website, a voluntary database to collect information on those that suffer, but it also as an "FDA Live" that updates weekly with mesh adverse events reported to the FDA. Feel free to use this as it's data purged through the FDA's API, straight from the source.

Posted by

on
Had the same procedure done, everyone told me there was nothing I could do with it. Had this done during surgery on my gall bladder, put in the mesh when done and stapled up, to this day still ave infection and abscess problems and it is still painful and tender.

Posted by

on
I had surgical mesh put in 2004. That same year I had to go back in the mesh was cutting up my vagina. Since then 3 more surgeries...I am incontinent again.

Posted by

on
I have suffered with my stomach since i had my surgery in 2005 and it has gotten painful at times as well i never had the money to get it checked out by a doctor that deals with hernias but i have told my doctor of my stomach problems

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