Hip Replacement Complications and Implant Failure

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Hip replacement surgery (hip arthroplasty) has been heralded as one of the greatest medical advancements of the past forty years. It has improved the quality of life for millions of people by helping them overcome painful arthritis and recover from hip fractures. Yet, a growing number of implant recipients have experienced implant failure and other complications associated with their hip replacements.

Advances in hip replacement technology have made hip arthroplasty one of the most common orthopedic procedures today, even in patients younger than 55.

The design limitations of hip replacements were pushed as they began to be used on younger, more active patients. Stronger materials have been utilized to simulate the natural motion of the hip joint. Now that these new designs have made implants available to a broader patient base, complications are increasingly more commonplace and sometimes more severe.

Particle Debris from Hip Implants

In total hip replacement/resurfacing, the new cup and the new ball/covering can lead to complications and implant failure. With every step, the surfaces of these two components rub together and the friction causes debris to be produced-as much as 100,000 to 1 million particles of debris with every movement. The type of debris depends on the materials used, and affects the type of complications suffered by a recipient.

Metallosis occurs when metallic debris builds up in the soft tissue surrounding the hip joint. Metallosis can lead to metal poisoning in patients with metal sensitivity and has been linked to several hip replacement complications, including:

  • Severe joint pain
  • Implant loosening or failure
  • Local tissue necrosis
  • Deterioration of bone around the implant
  • Formation of cysts or pseudotumors
  • Osteolysis

Cognitive problems, severe headaches, nervous system issues and emotional imbalance can occur if blood metal ion levels become too elevated.

Periprosthetic osteolysis is the loss of bone around the hip replacement. It is the most common long-term hip replacement complication and the cause of nearly 75 percent of implant failures. Osteolysis occurs when the body recognizes the implant as foreign and attempts to clean up particle debris by releasing enzymes and causing a chronic inflammatory condition.

Hip arthroplasty is viewed as a routine procedure and is performed over 450,000 times a year in the U.S. However, the side effects and complications associated with hip replacement can be very dangerous-even deadly. In addition to metallosis and osteolysis, others complications include;

  • Dislocation
  • Heterotopic ossification
  • Infection
  • Avascular necrosis
  • Component loosening
  • Periprosthetic fractures
  • Mortality rate of up to 2.5 percent for patients undergoing a revision surgery

Hip Replacement Lawsuit Attorneys

If you or someone you love has been harmed after receiving a metal-on-metal hip replacement, it is important to act quickly. The national hip replacement lawsuit attorneys at Phillips Law Firm can help. We represent patients across the United States who have been injured or hurt from a hip replacement.

If you are interested in learning more about your legal options, call us at 1-800-708-6000. Our hip replacement lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation. Remember our no fee promise. If we do not recover anything for you, you do not owe us an attorney fee.

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Implantable Pacemakers Recalled by Medtronic

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According to a June 10 Medtronic field safety notice, there is a low likelihood of malfunction in certain cardiac resynchronization therapy pacemakers (CRT-Ps). Medtronic is asking hospitals to return certain lots of the Consulta and Syncra devices manufactured between April 1 and May 13, 2013, after discovering a manufacturing problem that could prevent the device from functioning properly.

An “out-of-specification” weld on the devices could indicate that the devices aren’t properly hermetically sealed, allowing body fluids into the device and causing malfunction. “If this happens, it may cause loss of pacing output, which could potentially result in return of symptoms, including: fainting, or lightheadedness, dyspnea (shortness of breath), fatigue, edema (swelling),” according to an Australian Therapeutics Good Administration warning.

Medtronic says that the probable rate of malfunction is very low, affecting only about 1-2% of the devices, and as of June 21, the company has not received any reports of device failure due to the defect.

The company states that the manufacturing defects are confined to the two models specified and does not affect any other model or device. Initially, Medtronic had estimated that fewer than 700 patients had been implanted with the potentially defective devices, and later lowered that number to about 265. According to a company spokesperson, only about forty-four of those devices are in the U.S.

Medtronic released an updated notice on July 1, issuing new recommendations for patient care, telling doctors to warn their patients to seek immediate medical attention if they experience any of the symptoms of device failure. Medtronic also recommends that healthcare providers make case-by-case decisions when considering prophylactic replacement of any implanted devices and that they continue with routine follow-ups for these patients.

According to the U.S. Food and Drug Administration, there are about 1900 of the affected devices “in commerce.” The FDA considers this a Class II recall, defined as a measure reserved for “products that might cause a temporary health problem, or pose only a slight threat of a serious nature.”

Unfortunately, this recall does not sit well with consumer advocates who can’t help but notice how often Medtronic has been in the news as of late. The medical device giant has been battling lawsuits over their Infuse bone grafts and defibrillator leads in the past few years alone.

If you or someone you love has suffered a major medical complication because of a Medtronic product, it is important to know that you are not alone. The litigation process will require a competent and aggressive attorney to secure your rights and get you the compensation you deserve. To learn more about filing a Medtronic lawsuit call the experienced Medtronic lawsuit lawyers at Phillips Law Firm today. Call us at 1-800-708-6000. Our national Medtronic lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation.

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Avaulta Transvaginal Mesh Lawsuit Trial Has Begun Again

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On July 8, the first of four bellwether trials for C.R. Bard transvaginal mesh lawsuits began in the U.S. District Court of the Southern District of West Virginia. The plaintiff in the first transvaginal mesh multi-district litigation trial, Donna Cisson, claims to have suffered injuries from a device made of resin-based plastic that was not suitable to be implanted in the human body.

Yet on the second day of the trial, the judge declared a mis-trial. After initial opening statements, an expert in the field of gynecology took the stand. He told the jury that the Bard Avaulta mesh has since been removed from the market after it was implanted into Cisson. This information was in direct conflict with pre-trial rulings that this type of information was to be excluded because it could directly bias the jury. As a result, the judge declared it a mis-trial.

Now earlier this week, the trial for Donna Cisson has begun yet again. Cisson and her attorneys continue to claim that the Avaulta device that was implanted into her in 2002, caused extensive pain, bleeding, and bladder spasms that caused her to undergo two additional surgeries.

The transvaginal mesh devices commonly used to treat urinary incontinence and pelvic organ prolapse are currently under fire for the numerous health problems associated with their implantation in the body. The body’s natural foreign object response causes shrinkage of the device and can ultimately lead to deterioration of nerves, tissue and organs surrounding the transvaginal mesh device.

Women who have been implanted with faulty transvaginal devices made by C.R. Bard and other manufacturers have filed lawsuits against those companies by the thousands. In June 2012, a California jury awarded a woman a $5.5 million verdict for injuries she suffered from an Avaulta transvaginal mesh device.

A plaintiff in Atlantic County, New Jersey was awarded $3.35 million in compensatory damages and $7.76 million in punitive damages when a jury ruled against Johnson & Johnson. The plaintiff was awarded the $11.1 million verdict for injuries she suffered from ProLift, a recalled transvaginal mesh device manufactured by a subsidiary of Johnson & Johnson, Ethicon.

Plaintiffs allege that the manufacturers were aware of the serious health risks but chose not to make this information public. As a result, these injured women have suffered horrific injuries, including inflammatory disease, uncontrolled bleeding, and internal perforation.

Transvaginal Mesh Lawsuit Attorneys

If you or someone you love has experienced transvaginal mesh complications or injuries after a treatment for pelvic organ prolapse or stress urinary incontinence, the transvaginal mesh injury lawyers at Phillips Law Firm can help. Our attorneys understand that transvaginal mesh injuries are often painful and costly for our clients; therefore, if we do not recover anything for you, you do not owe us an attorney fee.

When medical companies are negligent—we hold them accountable. Call Phillips Law Firm at 1-800-708-6000.

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Hip and Knee Implants Should Come with a Warranty

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Thanks, in part, to aggressive advertising geared toward younger consumers and aging baby boomers, the number of Americans receiving hip and knee implants annually is expected to quadruple to 4 million by the year 2030. It is expected that by that time that 50 percent of the patients receiving implants will be under the age of 65.

The fact that most knee and hip replacements are not backed by a manufacturer’s warranty is a huge concern for these younger patients. These patient will need the replacement to last for a longer time if they get the implant at a younger age, and deserve to know how long medical device makers are will stand by their products.

The policy and advocacy arm of Consumer Reports, Consumer Union, has called on medical device manufacturers to provide a warranty that would allow patients to have defective devices replaced at no cost. Warranties would not only encourage manufacturers to produce a safer and more durable implant, but would also give patients a better understanding of how long the device is expected to last and what to do if their implant fails prematurely.

Currently, the cost for additional surgery and replacement of the defective device is predominately paid by patients or their insurance companies, including Medicare. Revision surgeries are more costly, lead to longer hospital stays, and could require additional surgeries. Costs for these procedures are likely in the hundreds of millions of dollars and it is estimated that 8 percent of all knee replacements and 18 percent of hip replacement surgeries in the U.S. are for revisions.

In a review of recalls for hip and knee implants, Consumer Union found that all major manufacturers have recalled a product, or line of products, during the last decade. The Johnson & Johnson ASR XL metal-on-metal hip implant is one of the most worrisome recent examples. Their device was recalled after national registries indicated that one in eight of the implants failed within five years in Australia, England and Wales. Debilitating symptoms from metal debris flaking off the device over time, such as cardiomyopathy and neurological problems, have been reported by some patients.

Unfortunately, under current law, manufacturers need only to prove that their product is “substantially equivalent” to a product already being sold in order to get their device to market. Since most new hip and knee implants are similar to ones already on the market, this fast-track clearance process, called 510(k), allows many new devices to be used without being reviewed for safety and effectiveness by the FDA.

Efforts by Consumer Union to urge Congress to require more premarket testing of hip and knee implants were blocked by the politically powerful medical device industry at last year’s reauthorization of the Medical Device User Fee Act.

Hip Impant Lawsuit Attorneys

If you or someone you love has experienced complications after a metal-on-metal hip implant, it is important to know that you are not alone. The national hip implant lawsuit attorneys at Phillips Law Firm can help. If you are interested in learning more about your legal options, call us at 1-800-708-6000. Our hip implant lawsuit attorneys are waiting to assist you 24/7, offering a free case evaluation. Remember our no fee promise. If we do not recover anything for you, you do not owe us an attorney fee.

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