Personal Injury Law Specialist in Phoenix, Arizona

An article in today’s New York Times discusses the alarming failure rate of metal-on-metal (MoM) implants. If you or someone close to you has complaints about a failed DePuy ASR, DePuy Pinnacle, Zimmer Durom, Zimmer NexGen, or Wright Medical hip or knee implant, please call Steve Leshner for a free consultation.

Metal Hips Failing Fast, Report Says
By BARRY MEIER
A British registry found that all-metal artificial hips failed at a significantly higher rate than those made from other materials.

The Food and Drug Administration responded to mounting concerns about the safety of metal-on-metal hip implants on Thursday, saying it would subject the devices to a two-day expert review that could lead to new standards.

The F.D.A. announced an advisory panel for June 27-28 that will gather input from scientists, researchers, patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements to be met before a device can be sold in the United States.

“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at the F.D.A.’s Center for Devices and Radiological Health, said in a statement.

Shares in orthopedic device manufacturers were lower after the announcement, with the Stryker Corporation down 0.7 percent, Zimmer Holdings down 1.1 percent and Johnson & Johnson off 0.3 percent.

Hip replacement surgery is a common, costly procedure intended to provide greater mobility and alleviate pain for people with joint problems, including arthritis.

About 270,000 hip replacements are performed each year in the United States, accounting for nearly 40 percent of all joint replacements, according to the British Medical Journal. Analysts say the procedure can cost upwards of $17,000.

But evidence has been growing for years that all-metal hip implants fail at higher rates than systems that use other materials. Patients who receive them have also been shown to have high concentrations of metal ions in their blood.

A recent study from the National Joint Registry of England and Wales showed that about 6 percent of people with the metal-on-metal variety needed additional surgery to replace or repair them after five years, compared with 1.7 to 2.3 percent of people who had ceramic or plastic systems.

The F.D.A.’s announcement on Thursday followed a May 2011 order from the agency requiring manufacturers of metal-on-metal implants to collect more safety data on the devices.

The F.D.A. said the upcoming advisory panel meeting would look at failure rates, metal ion testing, imaging methods, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems

Phoenix Arizona Personal Injury and Medical Malpractice Attorney Stephen I. Leshner is scheduled to present a seminar for lawyers on Advanced Expert Witness Deposition Tactics on March 25, 2011 in Phoenix, AZ. The seminar is sponsored by the National Business Institute.

Yesterday, Johnson & Johnsons lawyers informed class action Judges, Judge Goodwin (West Virginia) and Judge Higbee (New Jersey), that it is will stop selling Prolift Vaginal Mesh. Now, J&J is not calling it a recall. But the difference between stop selling and recall is purely semantics. Importantly, J&J has asked the FDA to place the existing 522 orders requiring additional studies for these products on hold.

Background: What Is Vaginal Mesh?

Vaginal mesh (also called transvaginal mesh, vaginal slings, transvaginal slings, and bladder slings) is a medical device that is surgically implanted to treat a condition called pelvic organ prolapse. These products have an extremely high rate of failure, and cause problems including infection, pelvic pain, punctured organs, urinary problems, and erosion of the mesh into the vagina. These are horrible, almost unspeakably embarrassing injuries.

There are many manufacturers, including C.R. Bard (Avulta) , AMS, Johnson & Johnson (through Ethicon), Boston Scientific, UGYTEX, and Covidien.

What Products Are Being Recalled?

Johnson & Johnson is ending sales of the following products in the United States:

• GYNECARE TVT SECUR
• GYNECARE PROSIMA Pelvic Floor Repair System
• GYNECARE PROLIFT Pelvic Floor Repair System
• GYNECARE PROLIFT+M Pelvic Floor Repair System

There is one product that is not being discontinued, but which will feature updated labeling–the GYNECARE GYNEMESH PS.

What Will The Court Do?

The lawyers in the Vaginal Mesh cases have a case management conference set in West Virginia in July. Right now, especially in light of this Prolift recall, plaintiffs’ lawyers will likely file the remainder of their Prolift vaginal mesh cases. The judge seems encouraged to start setting trial dates, which is a good sign that the cases may begin settling. Settlements routinely occur just before and after these initial trials in cases like this.

The parties are still working on some remaining discovery issues, and working on creating Plaintiff Fact Sheets (PFS) and Defendant Fact Sheets (DFS). The Fact Sheets are agreed-upon documents that each plaintiff and defendant fills out to provide the opposing side with some good preliminary information. Plaintiffs will disclose their medical and surgical history, demographic information, and other relevant information.

Phoenix, Arizona product liability lawyer Stephen I. Leshner is currently handling transvaginal mesh (TVM) cases. Please contact Steve for a free consultation if you or someone close to you has been injured by a defective TVM product.