Medical devices can save and improve lives. Unfortunately not all of them are tested properly before hitting the market, and some have injured patients.
Countless patients around the world depend on advanced medical devices. These products correct health issues that detract from everyday life. While cutting-edge products continue to revolutionize the field of medicine, all too often patients suffer debilitating injuries brought on by faulty medical products.
A growing number of patients experience severe complications with devices such as hip replacements, knee replacements and transvaginal mesh. Simply seeking a better quality of life, patients often are unaware of the risks of these procedures — risks that can far outweigh any of the device’s potential benefits.
It is a disheartening truth that companies like DePuy Orthopaedics, Zimmer Holdings Inc., Stryker Corp. and Johnson & Johnson rush new devices to market before researchers can sufficiently evaluate their safety and success rates in clinical trials.
The leaders in device manufacturing must be held responsible for the painful, sometimes life-altering effects that patients endure. Consequently, patients implanted with these poorly-tested devices are choosing to file lawsuits against negligent device makers. Those afflicted contend that manufacturers have a responsibility to ensure their products won’t harm consumers, and patients are demanding compensation for their pain, suffering and the steep costs of unexpected follow-up surgeries.
Dangerous Product Manufacturers Bypass FDA Approval
Frequently, unsuspecting patients are left wondering how injurious products could enter the market to harm consumers. Tasked with preventing such incidents, the U.S. Food and Drug Administration (FDA) approves and regulates new devices, primarily to ensure that their health benefits outweigh any known risks.
However, an alarming number of new medical devices sidestep FDA approval through a system known as the 510(k) program. The FDA typically evaluates new products with stringent premarket testing, but the process can be bypassed if a manufacturer can demonstrate that its product is “substantially equivalent” to one already on the market. With this proven, a new medical device can be marketed and implanted in patients without any clinical testing or review of outcomes.
While the 510(k) clearing process provides patients with quick access to innovations in medicine, there is an unsettling consequence: The FDA has cleared a flood of new devices without requiring manufacturers to prove their safety and effectiveness.
From 2005 to 2009, for example, 71 percent of the class III (highest-risk) medical devices cleared through 510(k) were later recalled over safety concerns.
Criticizing the potential risks of 510(k)-cleared devices, the U.S. Government Accountability Office has urged the FDA to improve the process for medical device review. Specific actions were suggested, and the FDA plans to fully comply by 2013.
Defective Knee and Hip Replacements
With the FDA clearing the majority of new knee and hip implants via the 510(k) program, clinical evidence continues to reveal the grave implications of the program’s flaws.
For instance, one class of device, the metal-on-metal hip implant, has exhibited particularly high rates of failure. Also, a growing number of patients fitted with artificial knees face similar complications when their devices fail to properly bond with the thigh bone.
Poorly designed knee and hip replacements often fail from improper placement or loosening after surgery. Bone fractures in the area around the implant may also occur, as can dislocation if the joint slips out of alignment. These issues can cause symptoms ranging from pain and swelling to an inability to walk. To fix these complications, patients often require one or more corrective procedures, known as revision surgeries.
DePuy Orthopaedics Devices
Notorious for clearing faulty medical devices through the 510(k) program, DePuy Orthopaedics is a multinational company owned by Johnson & Johnson. In 2010, safety issues prompted DePuy to recall one of its hip replacement devices, the Articular Surface Replacement (ASR) XL Acetabular system.
In metal-on-metal hip replacements like the ASR system, a metal ball connected to the leg’s femur bone rotates within a metal socket attached to the hip. Friction from everyday use wears these components down, releasing small metal particles into the body over time.
While each patient reacts uniquely to the metallic debris, it has been known to damage nearby tissue and bone. This can cause pain, swelling and loosening of the joint. In some cases, metal ions seep into the bloodstream and create a number of complications in the heart, thyroid gland and nervous system.
One U.K. study found that nearly 13 percent of ASR system patients required revision surgery within five years of receiving the implant. Similar devices made of plastic and ceramic typically last 15 years before complications arise.
Many Americans suffered injuries from the ASR system, and within one year of the recall more than 3,500 patients filed lawsuits against DePuy. The company also defended itself against hundreds of lawsuits over issues with another metal-on-metal hip device, the Pinnacle. By March 2013, DePuy was facing nearly 14,000 hip lawsuits.
In Australia, DePuy recalled its LCS Duofix Femoral Component, a knee prosthetic that caused pain, swelling, tissue damage and cysts to occur. Similar to the issue patients experienced with the ASR system, the LCS Duofix shed particles of alumina metal that damaged knee tissue. Patients endured severe pain, and some were unable to work for months. DePuy stopped selling the device in 2009, and since then patients have joined a class-action lawsuit to obtain compensation for their pain and suffering.
Zimmer Holdings Inc. Devices
Various knee and hip replacements produced by Zimmer Holdings Inc., another international giant in medical device manufacturing, offer equally concerning failure rates.
In July 2008, Zimmer ceased marketing and distribution for one of its all-metal hip implants, the Durom Cup. Zimmer designed this product for young and healthy patients who require durable and long-lasting implants, but far too many devices failed within a few years.
One year before the Durom Cup recall, an esteemed orthopedic surgeon and Zimmer consultant noticed suspicious complications with the device. After observing premature failure in more than 6 percent of patients whom he fitted with the Durom Cup, Dr. Larry Dorr notified Zimmer about the issue.
Despite ample evidence of loosening joints and failed bonds between the device and patients’ bones, Zimmer instead suggested the complications were due to Dr. Dorr’s incompetence as a surgeon. By July 2008, Zimmer recalled the Durom Cup, stating that the technical instructions given to surgeons proved to be inadequate.
Zimmer also manufactured artificial knees that were rife with complications. One product, called the NexGen CR-Flex, exhibited high rates of premature failure because it commonly did not bond with the femur as intended.
One orthopedic surgeon observed NexGen knee failure in 9 percent of 100 patients studied, which caused pain, looseness and often required revision surgery to have the device replaced.
Stryker Corp. Devices
In April 2012, Stryker Corporation issued an “Urgent Safety Alert” regarding two of its hip replacement models — the Rejuvenate and ABG II modular-neck hip stem systems. Stryker developed these systems to offer surgeons an unprecedented range of options as they custom-fit implants for each patient, but post-market surveillance revealed an excessive risk for serious complications after surgery.
The modular aspect of these systems refers to their interchangeable neck stem components. Because each patient’s anatomy is unique, Stryker created several modular-neck stems in varying dimensions. While these systems were intended to vastly improve the implant’s stability and range of motion, some patients instead experienced chronic pain, swelling and damage to nearby tissues.
These complications occur because the metal-on-metal joint between the head and neck stem components can shed tiny metal particles during everyday use. The debris can increase metal ion generation in the area surrounding the implant, which may result in an Adverse Local Tissue Reaction (ALTR). Patients with a high sensitivity to the metal ions may need revision surgery to correct tissue reactions like metal toxicity, bone dissolution, necrosis (premature cell death) and the formation of pseudotumors.
To prevent future issues with the devices, Stryker recalled the Rejuvenate and ABG II hip systems on July 6, 2012. Following the recall, Stryker immediately ceased global production and distribution of the faulty devices. Patients fitted with these modular hip systems are encouraged to contact their surgeon if complications like pain or swelling occur. If ALTR is suspected, medical surveillance in the form of blood work, an MRI or an ultrasound may be required.
Transvaginal Mesh Complications
Alerting the public of yet another scantily-tested medical device, the FDA has warned that surgical mesh, in certain procedures, can cause life-changing health complications. Composed of synthetic materials, surgical mesh is permanently implanted in patients to repair weak or damaged tissue.
From 2005 to 2010, the FDA fielded nearly 4,000 reports of adverse effects related to transvaginal mesh, which is used to treat women suffering from pelvic organ prolapse (POP) or stress urinary incontinence. Surgeons place the mesh transvaginally (through the vagina). To correct pelvic organ prolapse, the mesh supports the uterus, bladder and bowels and prevents them from descending into the vagina. And in stress urinary incontinence, the mesh supports the urethra to prevent involuntary urine leakage.
The FDA issued a Public Health Notification regarding serious complications with transvaginal mesh in 2008, but asserted that adverse events were rare. But by 2011, the FDA reversed its decision. Complications, in fact, were not rare among transvaginal prolapse repairs, as they were found to occur in 10 percent of the 75,000 surgeries performed in 2010.
In the July 2011 update, the FDA went on to say: “The FDA has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk.”
The FDA has ordered 33 mesh manufacturers — including Johnson & Johnson, Bard Medical, American Medical Solutions and Boston Scientific — to conduct safety reviews of their products.
One of the most common issues doctors observe in patients is mesh erosion, which occurs when the device migrates from its point of placement and cuts through the soft tissues of the vagina or pelvic organs. If the mesh protrudes out of the vagina, this is known as vaginal extrusion.
|In addition to erosion and extrusion, complications associated with transvaginal mesh include:|
|Urinary complications||Emotional distress|
These adverse effects often require surgical correction, but success isn’t guaranteed. Sometimes a woman’s life is drastically changed by a high-risk transvaginal procedure that her doctor recommended.
Mirena Intrauterine Device (IUD) Complications
Women searching for long-term birth control will find that the Mirena intrauterine device (IUD) is convenient and effective, but the possible side effects, like organ perforation and device expulsion, make the device risky. Mirena is a T-shaped device that is implanted into the uterus to prevent pregnancy for up to five years. The FDA approved it in 2000 and has received more than 45,000 reports of adverse events.
In December 2009, the FDA wrote Bayer, Mirena’s manufacturer, alerting the company that it was advertising false or misleading information about Mirena, claiming that women would feel great, even though reports show women experienced back pain, breast pain, acne and weight gain. The FDA also communicated to Bayer that it did not fully inform Mirena users of the extent of possible complications.
Despite these dangers, Bayer continues to sell Mirena. Women suffering from Mirena injuries have filed lawsuits against Bayer.
Risks of NuvaRing Birth Control
NuvaRing is a flexible ring that is inserted into the vagina once a month to prevent pregnancy. It was introduced in 2001. Since then, 5.5 million prescriptions have been written. The popular device reached international sales of $623 million in 2011. NuvaRing provides effective birth control, but it poses a serious risk of life-threatening blood clots. The blood clots can lead to heart attack, stroke and death.
In 2008, the FDA made safety label changes to NuvaRing after Public Citizen, a nonprofit consumer safety awareness group, submitted a petition representing more than 100,000 consumers seeking to ban NuvaRing. The FDA took action again in 2011, when it released a drug safety report referencing a study of 800,000 women using NuvaRing. The study showed that the risk of venous thrombosis — blood clots that can form in the veins and travel to the lungs — increased substantially for NuvaRing users compared with non-users of hormonal contraception.
More than 1,000 women have sued Organon and Merck after suffering serious side effects from NuvaRing.
INFUSE Bone Graft Side Effects
INFUSE bone grafts are used in spinal fusions for people with arthritis or other types of degenerative bone disease. The grafts, which are used about 100,000 times a year in the United States, are intended to relieve discomfort. However, they sometimes lead to side effects like severe back pain, difficulty breathing, leg pain and implant failure.
The U.S. Senate has scrutinized trials by Medtronic, the manufacturer of the grafts, showing that the approved uses come with hazards that were withheld from the public. Medtronic was accused of paying researchers millions in consultation fees and providing vacations in order to sway their opinion and entice them to conceal side effects. The company paid $40 million in 2006 to settle a civil case regarding these issues, and then was investigated again in 2011.
In 2008, the FDA alerted health care providers that using the INFUSE bone grafts for unapproved purposes could result in life-threatening complications. The alert noted that unapproved use might cause swelling of the neck and throat, resulting in problems with speaking, swallowing and breathing.
Hundreds of people have sent reports of adverse events to the FDA concerning INFUSE grafts. People suffering from graft injuries have filed lawsuits against Medtronic, accusing it of intentionally withholding reports of adverse events.