Finally – Victims of Stryker’s Latest Recall Receiving Notice

Lawsuits have been filed against Stryker since 2013 alleging that its line of TMZF hip replacement stems are a danger when combined with metal femoral heads. However, patients who have received this potentially dangerous combination of products are just now being notified. Oddly enough, Stryker is not the one doing the notifying. Despite recalling approximately 44,000 metal heads in 2016, Stryker has left it up to surgeons to notify patients. Some doctors have now taken it upon themselves to write to their patients explaining their concern over the product’s safety.

To compound the danger, Stryker’s instruction in its recall is for patients to “continue to follow up with their doctor at their normal scheduled appointment.” Most patients are released from the doctor’s care after one year of follow-up. So, if a patient’s implant has been in for a few years, then they are not scheduled for any follow-up appointments.

Dangerous Situation for TMZF Stem Hip Recipients with Metal Heads

This is a very dangerous situation for patients. All patients who received these implants should see their doctor to obtain baseline testing to see if, in fact, their device is already failing despite a lack of symptoms. However, since only a small handful of patients are even being told their implants are subject to a recall, thousands are left in the dark and have no idea they may be in danger.

These devices fail in much the same way tens of thousands of metal implants have failed over the past 10 years. At the connection between the TMZF titanium stem and the chrome/cobalt metal head motion leads to corrosion. This, in turn, leads to material loss. The process leads to toxic metal debris getting into the patient’s tissue and bloodstream. The metal debris can result in the death of both muscle and bone, as well as an inflammatory response leading to large fluid collections. Not all patients who suffer from this problem feel symptoms. Left untreated, the process can cause muscle and bone loss substantial enough to leave the patient with serious disabilities even after the bad device is removed and replaced.

Letter Sent from Local Surgeon

LFIT V40 recall

Read the letter here. Click on the image.

The latest letter that has come to my attention is from a surgeon at Holy Cross Hospital in Fort Lauderdale, Florida. The letter was sent to one of my existing clients who has already undergone revision surgery because of the above problems. He forwarded the letter to me.

Potentially thousands of these devices were implanted in Florida because of its large retirement population. Any patient implanted with a Stryker hip after 2006 should contact their surgeon and ask for their specific implant model. If the patient has any combination of a TMZF stem (Accolade, Meridian or Citation) and a metal head, they should insist on having a baseline blood chromium and cobalt study even if they are not having problems. Obviously, if the patient is having problems, he or she should consult with their surgeon as soon as possible. Finally, if the blood study shows elevated cobalt or chromium in their blood, they should insist on having a MARS protocol MRI scan of the affected hip.

One last comment about the recall. Stryker is only recalling a small subset of the metal heads it manufactured from 2002 – 2011. I have personally seen numerous failures in patients who received metal heads that are not on the recall list either because of their size or because they were manufactured after 2011. If it were me, I would not be satisfied if my surgeon told me I had nothing to worry about just because the metal head I have is not on the recall list.

Cardiovascular Risk Associated with ‘Low-T’ Drugs Should Be Studied, FDA Advisory Panel Says

Popular testosterone-replacement drugs have been called into question by a Food and Drug Administration advisory panel, which has voted in favor of restricting their use to men with medically related low testosterone.

Currently, the drugs are marketed mainly to men with age-related low testosterone as a relatively quick and painless cure for the condition, which adversely affects sex drive and can cause depression, fatigue and loss of muscle mass.

“The panel voted 20-1 in favor of restricting the drugs’ authorization to people with medically related low testosterone, such as a genetic disorder or a tumor,” a story on NBCNews.com stated. “If implemented, the restriction would mean companies could not market or promote their products for age-related low testosterone….”

Can testosterone gels and patches increase your risk of having a heart attack?

Can testosterone gels and patches increase your risk of having a heart attack?

The panel, comprised of the Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees, also voted in favor of requiring companies selling low-testosterone drugs to study and assess risks associated with the cardiovascular system. One of the questions the panel voted on was worded in the FDA presentation as follows: Is the overall benefit / risk profile of oral testosterone undecanoate acceptable to support approval of this product for testosterone replacement therapy?

Prescriptions to cure “Low T” have risen dramatically since 2010. WebMD’s Medscape Medical News reported U.S. sales of the drugs have increased 65 percent through 2013 and prescriptions soared to 2.3 million in 2013, up from 1.3 million in 2010. Most of those prescriptions were written for men ages 40 to 64.

In June of 2014, the FDA warned of blood clots in the legs as a potential result of taking low-testosterone drugs and mandated that information be included on product labels. The NBCNews.com story mentions more ominous risks. “The risk of deep vein thrombosis comes on top of the suspected risks of stroke, heart attack, and death from taking testosterone pills or using testosterone creams,” it was reported.

An FDA Drug Safety Communication explains the agency-approved testosterone products target men who experience the condition because of a specific medical condition. However, doctors have been prescribing those drugs to men with age-related “Low T.”
Products come in the form of gels, injections, patches and pills.

Men who think they are having symptoms related to low testosterone levels should consult their doctor and get a blood test.

Stryker Enters Settlement and Will Pay $1.43B to Settle Hip Implant Cases

Howmedica Osteonics Corp. (“Stryker Orthopaedics”), a subsidiary of Stryker Corporation, and Court-appointed committees of attorneys representing Rejuvenate Modular-Neck and ABG II Modular-Neck plaintiffs in New Jersey Multicounty and Federal Multidistrict litigations announced a Settlement Agreement. The lawsuits stem from two hip implants that Stryker recalled due to corrosion and other problems.

Stryker will pay $1.43 billion to settle thousands of lawsuits from patients who had to have surgery to remove the hip implants. The settlement agreement resolves state and federal lawsuits against the maker of orthopedics.

Courtesy of Chris Potter and Stockmonkeys.com

Settlement reached!

Under the agreement, patients who are eligible and elect to participate in the settlement will receive a base award of $300,0000, plus additional enhancements based on their individual cases and the procedures they underwent. Patients who had both hips replaces would get the base award for each hip. Many of those patients have undergone revision surgeries to remove the defective implants.

 

The settlement covers 4,000 lawsuits filed in the last two years in New Jersey and Minnesota, where cases from across the nation were consolidated.

Stryker expects that base payments will be paid in by mid-2015, while enhanced award payments are expected to be paid in late 2015 or the first quarter of 2016.

If you are a current client, please click here for further information.

More Stryker Rejuvenate and ABG II Cases Filed

Courtesy of WikiCommons and EraSoft24We’ve filed another 65 cases this week in the rapidly growing Stryker Rejuvenate litigation centered in New Jersey state court. Our clients have suffered terrible injuries caused by Stryker’s negligence in how they designed their Rejuvenate and ABG II hip implants. All of them have been forced to undergo painful revision surgeries due to corrosion and malfunctioning devices.

These Stryker hip systems were recalled in June of 2012 due to serious concerns that the modular junction between the neck were failing, causing the release of metal debris into the surrounding tissue and bloodstream. Since the recall, thousands of patients have been forced to undergo painful revision surgeries that require removing the femoral stem, neck, head and liner from the hip.

Victims of the recall can suffer from metal poisoning, called metallosis, as well as painful pseudotumors and fluid build-ups in their hip. Removal of the stem causes femoral fracture and removal of a large amount of soft tissue and muscle, in some cases leading to chronic dislocation requiring re-revision. Removing the recalled parts is not the end of the story for many. Many doctors are seeing return of the fluid collections and tumors up to one year after revision surgery. Too many of Searcy Denney’s clients have been ended up disabled and in every day pain due to multiple revision surgeries and serious femur fractures caused by the difficult removal process.

We currently have over 440 filed cases in New Jersey State court, and we expect to file many more before the end of summer. These 65 newly filed cases include victims from all over the country – not just Florida. If you are the victim of a defective Stryker implant we are here to help. We are more than willing to discuss your situation and potential case at no cost to you.

AAOS Demystifies Metal on Metal Hips

The American Academy of Orthopaedic Surgeons (AAOS) recently published an “information statement” for patients who have been affected by the recent metal-on-metal (MoM) hip disaster. The statement is not a rigorous academic analysis of the current situation with MoM hips, but it does provide a fantastic resource for patients who have questions about their own MoM hip.

The statement begins with a short history of why MoM hips were reintroduced to the medical marketplace in over the last two decades. At first, MoM hips were found to have lower wear rates than metal-on-polyethylene hips. Wear induced osteolysis, or the process that typically causes implant loosening or fracture, is a major concern for the orthopedic industry. It was thought that MoM hips could solve a major problem presented by polyethylene bearing surfaces – decreased wear rates would mean longer lasting hips and less revision surgeries over a lifetime. Since 1996, more than 1 million MoM hips have been implanted worldwide for this reason. Sadly, data from national joint registries has shown the failure rate of MoM hips to be 2-3 times higher than hips with polyethylene or ceramic bearing surfaces.

Hip resurfacingSo what happens when a MoM hip fails? Well, the patient usually experiences severe pain in their affected hip. This pain is usually caused by something known as “adverse local tissue reaction” (ALTR) or “aseptic lymphocytic vasculitis-associated lesions” (ALVAL) though there are a number of different possible reasons for pain with MoM implants – both extrinsic (something outside of the hip implant) and intrinsic (something wrong in the hip implant).

That’s why a clinical evaluation of your condition by an orthopedic surgeon is important to getting a correct diagnosis. They’ll look at your complete history to understand the root cause of your pain. A radiographic evaluation will also be integral to a correct diagnosis. Many orthopedic doctors are now using MRI with MARS imaging in order to see wear particles (the metal particles released by the hip when two pieces of metal rub against one in other with friction) and diagnose metallosis. Sometimes a doctor will prescribe a blood test for cobalt and chrome – the two metals typically used in MoM hip implants. Titanium testing is also becoming much more common. If you suspect metal poisoning from your MoM hip, we recommend asking your doctor if testing all three metals might be a good idea.

Finally, the AAOS recommends that all patients with MoM implants visit their doctors annually. Symptomatic or high risk patients (pain, gait changes, large diameter heads, high metal ion tests, recalled implant, etc.) should see their doctors every four to six months. The AAOS also recommends that orthopaedic surgeons prescribe repeat testing (MARS MRI, metal ion testing) on a regular basis for these patients.

The AAOS concludes their information statement with the incredibly important statement of “There should be a low threshold to perform a systematic evaluation of patients with MoM hip arthroplasty as early recognition and diagnosis will facilitate the initiation of appropriate treatment prior to significant adverse biological reactions.” Basically, it’s very important to monitor your MoM implant. If your surgeon doesn’t think so, then perhaps you should find a different one. Metal on metal hips can wreak havoc on a body – and your orthopedic surgeon should be aware of all possible damage to the one body you have.