Surgical mesh has been in the news a lot lately, and the news hasn't been good. There's been a rash of vaginal mesh lawsuits, recalls, FDA-mandated safety studies and reports of counterfeit mesh hitting the market. Let's sort it all out so you can address your surgeons' and patients' concerns with accurate information. Keep this in mind: Despite the recent headlines, repairing abdominal hernias with mesh is still considered the preferred method over suture repair.

Rash of lawsuits
A consolidation of almost 500 vaginal mesh lawsuits across the United States into a West Virginia courtroom will make it easier for pelvic prolapse and urinary incontinence patients to litigate against 4 major manufacturers (see "A Look at the Vaginal Mesh Lawsuits" on page 20). Federal courts have gathered lawsuits against Boston Scientific, American Medical Systems, Johnson & Johnson and C.R. Bard into so-called multidistrict litigations (MDLs) against each manufacturer, according to a ruling by the U.S. Judicial Panel on Multidistrict Litigation.

MDLs involving cases against Boston Scientific, AMS and J&J (owner of the mesh maker Ethicon) have been assigned to Chief Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia, who already presides over more than 330 nationwide lawsuits against Bard in an MDL started in October 2010. In the added MDLs, there are about 84 lawsuits against AMS drawn from 19 federal jurisdictions, 23 lawsuits against Boston Scientific from 14 jurisdictions and 37 against J&J from 22 different federal courts.

In the lawsuits, patients claim that the vaginal mesh, used to repair pelvic prolapse and urinary incontinence, had infiltrated into the vaginal wall and caused other complications, such as nerve damage, requiring revision surgeries that in many cases could not resolve the problem. More than 4,000 adverse events have been reported from vaginal mesh implants to repair pelvic organ prolapse.

One law firm trolling for women who've been injured by vaginal mesh implants to repair pelvic organ prolapse goes so far as to call vaginal mesh "dangerous medical devices." Lawsuits allege that vaginal mesh implants cause a litany of problems, including mesh erosion through the vagina (also called exposure, extrusion or protrusion); pain, infection and bleeding; pain during sexual intercourse (dyspareunia); organ perforation; and urinary problems.

FDA orders safety studies of women's surgical mesh
Amid reports of serious complications and patient deaths, the FDA in January ordered manufacturers of the implantable surgical meshes used in pelvic prolapse and urinary incontinence repair surgeries to conduct new studies of the products. The move came in response to a rise in the number of complications seen for female patients. Six patients in whom the mesh was used died and thousands more suffered serious complications between 2008 and 2010.

In all, 33 transvaginal mesh manufacturers, including Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates, will have to conduct surveillance studies involving hundreds of patients to assess the risks and benefits of these products. Once the studies have begun, the FDA expects manufacturers to follow patients for about 3 years to determine the frequency and severity of complications.

FDA officials said in September that serious complications associated with inserting the mesh vaginally to repair prolapse are "not rare'' and that it is not clear whether this technique "is more effective than traditional non-mesh repair.''

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for prolapse repair, including reports of 3 deaths due to surgical complications. It also received 1,371 adverse event reports for mesh slings used to treat urinary incontinence, which also included 3 deaths, during this time.

The FDA stressed that the order didn't cover all uses of surgical mesh to treat incontinence and that the safety of such devices when surgically implanted through the abdomen was well established.

The FDA noted that mesh placed abdominally for prolapse repair may result in lower rates of mesh complications compared to transvaginal prolapse surgery with mesh.

FDA warning: fake surgical mesh
In 2010, the U.S. Food and Drug Administration warned surgical facilities that counterfeit polypropylene surgical mesh products have been distributed under the Bard Davol brand.

The agency and the Murray Hill, N.J.-based manufacturer identified 4 counterfeit products and 14 counterfeit lot numbers. Facilities that find any of the following products, sizes or lot numbers in their inventory are urged not to use them, says the FDA, as they have not been manufactured by Bard. See tinyurl.com/7jgd2le for a listing.

Facilities that discover any of these products are asked to contact Bard Davol at (800) 556-6275 and the FDA Office of Criminal Investigations at (800) 551-3989 or fda.gov/oci.

Last September, a federal court in South Carolina rejected 2 medical device distributors' requests to dismiss a lawsuit holding them accountable for post-op complications stemming from the use of counterfeit surgical mesh they supplied to a surgical facility.

A patient named Heyward Thomas Jones and his wife filed the suit against Ram Medical and Medline Industries, alleging negligence, product liability, breach of warranty, fraud, violation of South Carolina's trade practices and violation of federal racketeering laws.

After undergoing a surgical procedure that implanted the mesh, Mr. Jones developed a "severe abdominal staph infection," according to court records, and required several additional surgeries to repair the damage.

His attorneys argue that the companies named in the lawsuit knowingly "sold, manufactured, and/or marketed counterfeit and otherwise defective surgical mesh," about which the FDA had issued warnings. These actions constitute violations of consumer law, they note.

While the distributors countered that state warranty laws did not apply to them and that the trade law allegations failed to state a valid claim, among other arguments, the court's Aug. 8 ruling allowed the plaintiffs to proceed with their claim, even the federal racketeering charges.

"Plaintiffs point to the FDA Notice of Recall and argue that Defendants have distributed and sold 15 lots of counterfeit surgical mesh," the ruling reads. "Plaintiffs allege there are potentially 150 individual victims that have been implanted with counterfeit surgical mesh. ... Plaintiffs argue further that the purpose of the sale was to defraud individual patients into paying full price for an inferior counterfeit good, which is common to all potential victims."

The patient's attorneys declined comment. Attorneys for Ram Medical and Medline did not respond to a request for comment.