Relevant FDA Communications on Urogynecologic Mesh

The following article will give the reader a comprehensive overview of the FDA’s communications to date concerning surgical mesh when used transvaginally in pelvic organ prolapse surgeries. The article An Appraisal of the Food and Drug Administration Warning and Urogynecologic Surgical Mesh, published in the Current Urology Reports (2012, 13:231-239) gives an overview of the FDA’s conclusions regarding the use of surgical mesh in POP surgeries. The first Public Health Notification issued by the FDA came out in 2008 after over a thousand women submitted adverse health reports following transvaginal surgery using gynecologic mesh. Three years later the FDA issued an update to that report regarding the safety and effectiveness of mesh in POP surgery. At this time the agency reviewed the currently available safety data and scientific research on gynecologic mesh.

This article states that it is estimated that over a third of pelvic organ prolapse surgeries implement surgical mesh and that 75% of all these surgeries were done transvaginally. These numbers come from the over 300,000 women who undergo pelvic organ prolapse surgery annually in the U.S. and over 260,000 who undergo a surgical procedure for stress urinary incontinence. The FDA states that as far as SUI surgeries go, “more than 80% were done transvaginally with mesh.” The FDA’s conclusion is that although POP surgery done transvaginally may restore the woman’s body anatomically, there are few if any benefits over surgeries which do not implement urogynecologic mesh. 

How Effective have the FDA’s Warnings on Urogynecologic Mesh Been?

This article will detail the relative effectiveness of warnings issued by the FDA regarding Urogynecologic mesh use. According to the article, An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh, published in Current Urology Reports (2012, 13:231-239) manufacturers market surgical mesh kits with a goal of increasing speed and ease of placement. The FDA reports over the past few years have sought to increase the awareness of the potential risks of surgical mesh when used in a transvaginal surgical procedure despite manufacturer’s claims.

More and more often reports are coming out which emphasize the fact that surgeons who use these mesh kits must have specialized training which enables them to “recognize and manage the complications of surgical mesh implants.” Governmental regulation of these mesh devices has also come under fire; while there are many different agencies in charge of regulation and reporting, women have nevertheless been harmed by transvaginally placed mesh implants. 

FDA Warnings on Urogynecologic Mesh: An Overview

This article will detail the original warnings the FDA issued regarding urogynecologic mesh when used in pelvic organ prolapse surgical applications. According to an article titled An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh published in Current Urology Reports (2012 13:231-239), permanent surgical mesh has been used in various applications for several decades, having been used in the repair of hernias since the 1950’s.

The FDA’s July 2011 report on Urogynecologic Surgical Mesh defines surgical mesh as “a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.” Beginning in the 1970’s surgical mesh made its appearance in abdominal surgeries for pelvic organ prolapse, then in the 1980’s surgeons began using synthetic slings in the treatment of stress urinary incontinence. It was not until 1996, however, that the FDA approved a type of mesh particularly for use in stress urinary incontinence surgical procedures. Some six years later, in 2002, the Federal Drug Administration approved surgical mesh as an application for the treatment of pelvic organ prolapse. 

Consolidation of Stryker Rejuvenate Hip Lawsuits Placed in New Jersey

The state of New Jersey is expected to consolidate at least ten StrykerRejuvenate and ABGII hip implant lawsuits before one judge in order to expedite the handling of these cases. Multi-district and multi-county litigation is described by Class Action Litigation website as a procedure utilized by federal and state courts to transfer all pending cases which are very similar in nature before one judge. This procedure allows lawsuits to move in a more expeditious manner through the discovery phase while still allowing the injured party to seek an individual trial and have their settlement adjusted based on the degree of injury. This is unlike class action lawsuits which dictate that all members share equally in the settlement even though it is unlikely that all injuries would be equal. The first ten cases are coming from Florida, Minnesota, New Jersey and Arizona. Hackensack, NJ was chosen as the consolidation point because it is close to Stryker headquarters.

Problems With Rejuvenate and ABGII

The lawsuits followed the recall in July of 2012 for the Rejuvenate and ABGII. The recall was voluntary on the part of Stryker and cited the risk of fretting, corrosion and the release of metal ions as the reason for the recall. Pain, inflammation, necrosis, metallosis and total failure of the hip implant can all result from the fretting and corrosion of the hip implants. These implants were originally marketed as a way for younger clients to be able to continue their levels of activity as they were believed to last from 15-20 years. Stryker’s innovative design offered a variety of necks and stems, allowing physicians to more closely match the implant to the size and activity level of the patient. Even though the Rejuvenate and ABGII are not all-metal (they have a ceramic ball and a plastic cup liner) they have the same potential for the release of metal ions into the body as the all-metal implants. 

Sales Dip for Stryker Following Hip Implant Recalls

Stryker sales have shown a definite dip in the quart since the recall of the Stryker Rejuvenate and ABGII hip implants in July. The hip implant recall came just months after Stryker issued an Urgent Field Safety Notice to hospitals and physicians in April of 2012 citing the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release. Stryker’s hip implant sales dropped nearly 10 percent while its knee implant sales dropped 4.3 percent.

Why the Dip in Revenues?

A Stryker company official stated the recalls of the Rejuvenate and ABGII had only a “modest impact” on the company’s third quarter drop in sales. While the recalls certainly would have impacted Stryker’s revenues, the overall economy may also have played a part. Joint replacement surgical procedures are considered elective most of the time. Those with insurance may delay the surgery to avoid missing work while those without insurance likely cannot afford the procedure. Stryker’s CFO, Curt Hartman also stepped down after two decades at the helm. He reportedly received a 1.5 million dollar separation package although he will remain as an adviser to Stryker through February, 2013. 

Why Diagnosing Problems in Stryker Rejuvenate Hip Implants is So Difficult

When the Stryker Rejuvenate and ABGII were recalled in July of 2012, citing potential risk of fretting and corrosion at the neck juncture, many of the implants had already been removed during revision surgeries. Unfortunately, since most physicians were unaware of the problems with the implants, the operative reports were unlikely to list this corrosion. In other words, since the doctors hadn’t been told what issues to look for, there were few records stating that corrosion was a factor in the revision surgery. When Stryker originally told hospitals and surgeons (in an Urgent Field Safety Report in April of 2012) that there could be corrosion or fretting and release of metal ions, there was still no mention of that corrosion occurring anywhere except at the neck juncture.

Therefore, the neck juncture would likely have been the only place physicians would have examined when taking out the implant. In the same vein, when implant recipients came to their doctor complaining of pain or other symptoms, the doctor would have ordered x-rays, an MRI and a bone scan. Again, without clear information regarding what to look for, many physicians might have attributed their patient’s complaints to external issues such as the aging process.  The Rejuvenate, unlike former metal-on-metal hip implants, is a four-part device with a ceramic ball and a plastic liner in the cup. Because of these improvements, it was believed there would be no metal parts rubbing against one another causing metal ion shear. 

Stryker Rejuvenate Hip Implant: What is the Real Problem?

Just this past July Stryker Orthopedics issued a voluntary recall of their Rejuvenate and ABGII hip implant systems citing a potential for fretting and corrosion at the metal neck junction. The FDA convened a panel shortly before this recall to discuss the merits of continuing to use metal-on-metal hip implants due to the high number of complications suffered from recipients. The design of the Rejuvenate was believed to overcome most issues associated with the all-metal hip implants as it allowed surgeons to custom-fit the stems and necks of the implants to the size and relative activity level of the patient.

The Rejuvenate Design

The Stryker Rejuvenate consists of a ceramic ball which fits into a plastic-lined socket. Because there was no metal-on-metal ball and socket it was believed there were no metal surfaces which could potentially rub against one another, causing metal ion debris to enter the surrounding tissue or bloodstream. The Rejuvenate is essentially a two-piece system in that the properly sized metal stem and neck connect to one another then connect to the ceramic ball. The neck is made of chromium and cobalt, just like the all-metal implants and the stem is coated with titanium. Even so, by using a ceramic ball and a plastic-lined socket, it was believed there would be no issues regarding metal ion debris.

Motorcycle Accidents in the State of Texas

As motorcycle riding has grown in popularity over the past decade it might surprise some to realize that a large portion of these additional motorcyclists are comprised of the “over-fifty crowd.” Contrary to the stereotype of the motorcyclist who drives recklessly and too fast, this group of motorcyclists generally drive their bike in the same manner they drive their automobile—safely and respectful of the other drivers on the road.

Texas Motorcycle Facts

Although the nation has seen a decline in the overall number of motorcycle fatalities, the state of Texas has actually had an increase in motorcycle deaths, with the majority of these deaths occurring in those between the ages of 20 and 29. It can be traumatic for anyone involved in an accident of any type however those who are injured in a motorcycle accident are much more likely to suffer death or serious injury.  There is little to no protection for the motorcycle rider when he is hit by a three-thousand (or more) pound hunk of metal, steel and glass.

What Happens Following a Trucking Accident?

There are nearly half a million collisions involving large commercial trucks each year; as many as 5000 of those involve fatalities with the state of Texas having between 250 and 450 trucking fatalities annually. In fact, the fatal crash rate for large trucks is 2.4 deaths per 100 million vehicle miles traveled which is fifty percent higher than the rate for other vehicles on the road. Because of the great disparity in size between a loaded commercial truck and a passenger vehicle 98 percent of these trucking fatalities are occupants of the smaller vehicle. A normally loaded 18-wheeler can take up to 350 feet to come to a stop while an overloaded truck will take an even longer distance.

Factors in Trucking Accidents

Trucking accidents are the result of a variety of factors including truck driver error, distraction or fatigue, mistakes on the part of the driver of the passenger vehicle, and mechanical failures which are common to 18-wheelers. The scores of victims of trucking accidents may wonder how the system which is meant to keep us safe has failed time after time. Those who survive a trucking accident likely find themselves totally immersed in the health of those involved in the accident, particularly in instances where injuries are extremely serious. The focus is on medical care and the ongoing treatments required leaving little time or energy to contemplate the medical bills stacking up, the lost wages which are resulting in regular bills going unpaid and the long-term effects resulting from the trucking accident. Those involved in a trucking accident may have wondered what the “other side” was doing in the days and weeks following the collision.

When Trucking Accidents Occur in the State of Texas

The City of Houston is well-known for the number of large commercial trucks which share the roadways with other vehicles. Because the Houston area is a primary shipping route, with over three million residents in Houston and outlying areas, it is considered one of the busiest thoroughfares in America. There is also considerable truck traffic resulting from the surrounding petroleum-transport areas as well as the many 18-wheelers from out of state which continuously travel through the Houston area. When you factor in the amount of truck traffic in the area you can see that accidents are much more likely to happen simply due to the sheer volume of truck traffic.  In 2008 Houston saw 421 fatalities involving large commercial trucks and although that number was down to 284 fatalities by 2010, the numbers are still sobering.

Why 18-Wheelers are Dangerous to Smaller Vehicles

The Houston area accounted for approximately 8 percent of all fatalities associated with trucking accidents in the entire United States. Considering the sheer size of an 18-wheeler—particularly when it is fully loaded—in the event a truck crashes into a passenger vehicle, those in the smaller vehicle are obviously at a clear disadvantage. Even though trucks are now required to have under-ride bars at the rear, when a passenger car runs into the back of an 18-wheeler the impact is four times as likely to cause death than when the reverse is true (when the 18-wheeler rear-ends a passenger vehicle). A loaded truck easily weighs 20-30 times as much as a passenger vehicle meaning it takes a good forty percent longer distance to come to a complete stop. In the end, when an 18-wheeler collides with a smaller vehicle it is highly likely there will be serious injuries or death.

When Truckers Take to the Road Do They Look Out for Your Safety?

You’ve probably noticed drivers who are texting, talking on their phones, applying makeup, eating, or any number of other activities which distract them from driving and put other drivers and passengers at risk. Now, imagine that person who is not paying attention to the road is a truck driver. When you consider that a fully loaded truck needs the length of a football field to come to a complete stop—assuming it is traveling 60 mph on a totally dry road--you can see that when a truck driver is distracted, even for a moment, a tragic accident can result. The most recent federal regulations mandate shorter braking distances for commercial trucks however don’t affect existing 18-wheelers, only newly manufactured trucks.

While all drivers should avoid distractions which can lead to accidents, there is a large disparity between a crash between passenger vehicles and a crash involving a commercial truck and a passenger vehicle. A fully loaded truck is 20-30 times as heavy as a passenger vehicle and in a collision between the two the passengers in the smaller vehicle rarely fare well. Of the half a million trucking accidents in the United States each year approximately 5,000 of those will result in fatalities and a large percentage of the remainder will result in very serious injury to those in the passenger vehicle. Truck drivers are constantly under pressure to get their loads delivered; both from their employers and even from their own family members as their paycheck depends on the time they spend behind the wheel of the truck.