You are receiving this letter because Bailey & Galyen had or has an attorney client relationship with you or a family member. As such, we want you to know about these dangerous medical devices and drugs that have caused serious injuries and damages: Metal on Metal Hip Implants, Hernia Mesh Implants, Inferior Vena Cava (IVC) Filters and Xarelto.
METAL-ON-METAL HIP IMPLANTS
Many people have hip pain and stiffness or difficulty walking. When these symptoms do not respond to physical therapy, patients may be advised to undergo total hip replacement. One of the most common kinds of hip replacement uses a metal-on-metal (MoM) hip implant in which the “ball and socket” of the device are both made from metal. While intended to restore mobility and relieve pain, the MoM devices can lead to serious complications and injuries, such as some or all of the following:
- Disassociation (head and stem come apart)
- Metal debris in system
- Corrosion of the implant
- Clicking, popping, and/or grinding of the hip joint
- Additional hip replacement
- Hip revision surgery
- Elevated cobalt levels
Metallosis, as listed above, results when the contact between the metal ball and socket causes metal particles to wear off the device into the space around the implant. This may cause metal ions, such as cobalt and chromium, from the metal implant to enter the bloodstream.
Those metals can cause damage to bone and/or tissue surrounding the implant, and cause pain, implant loosening, device failure, and the need for revision surgery. Unaddressed, the failure of a MoM implant can lead to permanent and extensive damage to bone, muscle and nerves.
MoM products are made by Stryker (LFIT and Rejuvenate), DePuy, Biomet, Pinnacle, Smith & Nephew.
MoM hip failure is so prevalent that the FDA has issued General Recommendations for Orthopaedic Surgeons for before, during and after MoM hip replacement surgery. In the FDA’s General Recommendations for Orthopaedic Surgeons After MoM Hip Replacement Surgery, the FDA alerts the surgeon to consider testing to assess their patients’ MoM related injuries.
This Recommendation suggests MRI, CT scan and Ultrasound testing for symptomatic patients. MoM hip implants have the same adverse effects as other types of hip implants, including infection, loosening, bone loss, device or bone fracture, and joint dislocation, but the metal particles from a MoM implant may cause a reaction around the joint, leading to deterioration of the tissue around the joint, loosening of the implant and failure of the device. Metal ions from a metal-on-metal implant will enter the bloodstream. Adverse reactions to these metal ions could cause additional medical problems such as:
General hypersensitivity reaction (skin rash)
- Neurological changes including sensory changes (auditory, or visual impairments)
- Psychological status change (including depression or cognitive impairment)
- Renal function impairment
- Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)
HERNIA MESH IMPLANTS
Hernias occur when a hole or weak spot occurs in the muscle or connective tissue that allows an organ, intestine or fatty tissue to come through the body cavity or abdominal wall. Two of the most common hernias occur in the inner groin (“inguinal”) and in the general abdominal or ventral wall (“ventral”). Hernias must be addressed, and ultimately corrected by surgery. The surgery can be laparoscopic where several small incisions that are made allow the surgeon to repair the hernia with surgical tools, or by open repair where an incision is made to perform the repair. Hernia mesh has been used frequently in the incisional repair procedure. While surgical mesh may decrease the high hernia recurrence rate, it has many serious complications. The FDA’s own analysis of hernia mesh medical device adverse event reports and of peer-reviewed, scientific literature found that the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration and mesh shrinkage (contraction).
There are two polypropylene mesh “sandwich” products, Ethicon’s Physiomesh and Atrium’s C-QUR. In 2006, Atrium began to market and sell its C-QUR product, and in 2010, Ethicon began to market and sell Physiomesh. The word “sandwich” is used here to describe the polypropylene component being laminated between two layers of poliglecaprone, a bioresorbable polymer used to form an anti-adhesion barrier between the polypropylene and the host tissue. This anti-adhesion barrier increases the risk that the graft will not incorporate into the abdominal wall, causing the graft to fold, buckle and migrate, posing a threat to adjacent organs. It is also known to incite an inflammatory response in the implant’s surrounding soft tissue. That inflammatory response can cause complications that include but are not limited to pain, graft rejection, graft migration, organ damage, adhesions, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis, and death.
On May 25, 2016, Ethicon sent a worldwide letter to doctors recalling their hernia repair product Physiomesh. On August 9, 2013, the FDA announced a class 2 recall of the C-QUR mesh.
INFERIOR VENA CAVA (IVC) FILTERS
An IVC FILTER is a small medical device that is inserted into the inferior vena cava, a large blood vessel that brings blood from the lower half of the body into the heart. These filters are a temporary measure to catch blood clots and prevent them from traveling into the lungs.
In recent years, inferior vena cava (IVC) filters have been at the center of controversy and litigation. Reports of defective IVC filters, left in the body too long, have been associated with serious health consequences and even death.
Retrievable IVC filters are designed to remain in the body for a short period of time, and must be removed when the risk of PE diminishes. When not removed in a timely manner, these filters can cause serious health problems, including:
- Perforation of the IVC, lungs, and heart
- Severe chest pain
- DVT (blood clot) in the lower limbs
- Fluid buildup around the heart
These life-threatening complications are usually the result of a defective medical device. Though there are several manufacturers of IVC filters, there are two that have been the center of litigation: Cook Medical and C.R. Bard. Five filters, in particular, have been associated with an increased risk of injury:
- Cook Celect
- Cook Gunther Tulip
- Bard G2 Express
- Bard G2
- Bard Recovery
Xarelto is a newer anti-coagulating agent (blood thinner), preventing blood from clotting. originally researched, developed, and clinically tested by Bayer AG in 2010. Through a joint-venture agreement, Janssen R&D, LLC acquired rights to co-develop Xarelto in the U.S. Janssen also filed and supported NDA process for FDA approval. Janssen holds U.S. marketing rights for Xarelto, and Bayer AG co-promotes Xarelto to US hospitals through its well-established sales force.
Xarelto received its first approval as a prophylaxis in preventing Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in patients undergoing hip or knee replacement surgeries on July 1, 2011. A short 4 months later, on November 2, 2011, Xarelto was approved for treatment of DVT and PE, and the reduction in risk for DVT and PE. This approval opened the door to Xarelto’s enormous financial potential for Janssen and Bayer. Since November 4, 2011, Xarelto has been approved for treatment to reduce the risk of stroke and systemic embolism in patients with non-valvular Atrial Fibrillation (or Afib).
Xarelto is prescribed to reduce the risk of stroke and blood clots in individuals with atrial fibrillation, to treat deep vein thrombosis and pulmonary embolisms, and to reduce the risk of blood clots forming in the lungs and legs of individuals following knee or hip replacement surgery. Its advantage over the class of anticoagulant drugs is that it does not require regular blood monitoring, no frequent dosage adjustments, and no known dietary restrictions. However, Xarelto can pose serious and life-threatening uncontrolled bleeding.
Xarelto has been linked to:
- Gastrointestinal bleeding
- Cerebral hemorrhage
- Excessive menstrual bleeding
- Excessive nose bleeds
- Unexplained bruising
- GI discomfort
- Blood in stool and/or urine
Manufacturer Janssen failed to provide adequate warnings about the risks of taking Xarelto. It failed to advise the medical community and its patients that there is no antidote, meaning that once a bleed develops, doctors may have no way to stop the bleed.
If you, a friend or family member had one of these medical devices implanted in them or suffered a serious injury from the dangerous drug, Xarelto, call Bailey & Galyen at 281.549.9555 to discuss your potential product liability claim against the medical device and drug manufacturer. The doctor who implanted the medical device or prescribed the drug is rarely sued in these cases, as these are product defect cases against the manufacturer of the defective and dangerous products.