Personal Injury Law Specialist in Phoenix, Arizona

British experts at the world’s biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements, citing an analysis showing they have to be fixed or replaced more often than other implants.

All-metal hip joints were already under scrutiny over how long they last. Last year, regulators in the United States asked makers to conduct safety studies on them. Most artificial hip joints are plastic or ceramic.

In the new study, experts analyzed data for more than 400,000 hip replacements from the National Joint Registry of England and Wales from 2003 to 2011. More than 31,000 of those were metal-on-metal devices.

After five years, about 6 percent of people with the metal-on-metal variety needed surgery to fix or replace them. That compares with 1.7 to 2.3 percent of people who had ceramic or plastic joints.

Doctors usually expect hip joints to last at least a decade. The study was published online Tuesday in The Lancet, a British medical journal. It was financed by the National Joint Registry.

If you or someone close to you has been injured or is suffering from a defective metal-on-metal hip, including DePuy ASR, DePuy Pinnacle and Wright Medical hip replacement systems, please call Phoenix, Arizona hip replacement defect attorney Steve Leshner for a free consultation.

All artificial hip replacement systems have risks related to implant or material wear. Metal-on-metal hip (MoM) replacement systems have unique risks in addition to the general risks of all hip implant systems.

Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream.

Orthopaedic surgeons take several precautions before and during the implantation surgery to try to optimize the way in which the ball and socket rub against each other so that fewer wear particles are produced. However, there is no way to fully avoid the production of metal particles.

Different people will react to these metal particles in different ways. At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is sometimes referred to as an adverse local tissue reaction (ALTR) or an adverse reaction to metal debris (ARMD). Such a reaction may cause the implant to become loose or cause pain. Ultimately this can require a revision surgery where the old device is removed and replaced with another one.

In addition to these reactions to metal near the joint and implant, there are some case reports in the literature of a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.

Patients who have MoM hip implants should be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include:

· Pain in the groin, hip or leg

· Swelling at or near the hip joint

· A limp or change in walking ability

There are many reasons why any of these symptoms may arise or worsen after surgery and it does not necessarily mean that a reaction to the metal particles from the device is taking place. A thorough evaluation by an orthopaedic surgeon is needed to determine the actual cause. Besides a physical exam of the hip, the orthopaedic surgeon may consider several tests to evaluate these symptoms including:

· Special imaging tests

· Using a needle to remove fluid from around the joint (joint aspiration)

· Blood tests, including checking levels of metal ions in the blood

Patients who receive a MoM hip implant should also pay close attention to changes in their general health or new symptoms outside their hip including symptoms related to their:

· Heart (chest pain, shortness of breath)

· Nerves (numbness, weakness, change in vision orhearing)

· Thyroid (fatigue, feeling cold, weight gain)

· Kidney (change in urination habits)

In April 2010, the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients implanted with MoM hip replacements. The recommendations included blood tests and imaging for patients with painful MoM hip implants.

There are several differences between the U.K. and U.S. regulatory systems and some of the U.K. data may not be directly applicable to the experience in the US. For example, some of the devices available in U.K. are not marketed in U.S. Therefore, the frequency of the reactions described above, in the U.S. is unknown. For this reason, FDA is in the process of gathering additional information about adverse events in people with metal-on-metal hip implants.

At the current time, there is no evidence to support the need for checking metal ion levels in the blood or special imaging if patients with MoM hip implants have none of the signs or symptoms described above and the orthopaedic surgeon feels the hip is functioning properly. The FDA is recommending that asymptomatic patients with MoM hip implants continue to follow-up with their orthopaedic surgeon as prescribed.

If patients with MoM hip implants develop any of the symptoms above, it is very important for them to make appointments with their orthopaedic surgeons promptly for further evaluation.

If patients with MoM hip implants develop any new or worsening symptoms outside of their hips, or if they are referred to doctors to evaluate new conditions, they should let the doctors know that they have MoM hips.

Stephen I. Leshner, a Phoenix plaintiffs personal injury, accident and medical malpractice attorney has been named to the Arizona Super Lawyerslist as one of the top attorneys in Arizona for 2011. This is the fourth consecutive year Steve has been so honored. No more than 5 percent of the lawyers in Arizona are selected by Super Lawyers.

Super Lawyers, a Thomson Reuters business, is a rating service of outstanding lawyers from more than 70 practice areas who have attained a high degree of peer recognition and professional achievement. The annual selections are made using a rigorous multi-phased process that includes a statewide survey of lawyers, independent research evaluation of candidates, and peer reviews by practice areas.

The Super Lawyers lists are published nationwide in Super Lawyers magazines in leading city and regional magazines across the country. Super Lawyers magazines also feature editorial profiles of attorneys who embody excellence in the practice of law. For more information about Super Lawyers, go to superlawyers.com.

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