What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean? Letter to Hip Makers Mean?
The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

Will New FDA Orders Lead to a Recall of All Metal-on-Metal Hip Implants?

Will New FDA Orders Lead to a Recall of All Metal-on-Metal Hip Implants?

U.S. Food and Drug Administration orders 21 hip makers to blood test their patients for metal.

The U.S. Food and Drug Administration, the governmental organization that protects public health, entered the battlefield with the Johnson & Johnson's DePuy recall and ordered 21 manufacturers to collect information from patients - including blood tests for metallic ions. This broad use of the agency's authority will clarify failure rates of metal-on-metal implants and drop the hammer on Johnson & Johnson.

"This is a disaster for J&J," said James Moriarty, senior partner at Moriarty Leyendecker. "It will be a public health nightmare and show how metal-on-metal hip implants can cause metallosis." (the swelling around metal implants as a result of corrosion or an allergic reaction).

Johnson Takes $3 Billion Hit on Hip Recall

Johnson & Johnson took quarterly charges of more than $3 billion, largely related to the recall of artificial hips, and gave a 2012 earnings forecast below analysts’ estimates on Tuesday.

The company’s DePuy Orthopedics unit issued an extensive recall of its “metal-on-metal” hip replacement devices in 2010 after they shed metal fragments, causing disabling injuries.

The fourth-quarter charges will allow money to be set aside for patients and lawyers involved in product liability litigation.

“The hip recalls worry me because their eventual costs are unknown,” said Jeff Jonas, an analyst at Gabelli & Company, who noted that the fourth-quarter charges included $800 million for medical costs of the recall.

The company forecast 2012 earnings of $5.05 to $5.15 a share, compared with the consensus Wall Street view of $5.21.

William Price, a company spokesman, said most analysts had not factored in damage from the stronger dollar.

Johnson & Johnson reported better-than-expected fourth-quarter earnings, helped by favorable taxes and sales of new prescription drugs. The company earned $218 million, or 8 cents a share, in the quarter. That compares with $1.9 billion, or 70 cents a share, a year earlier, when it also took charges for recalls of hip replacement devices.

Excluding special charges, Johnson & Johnson earned $1.13 a share. Analysts had expected $1.09, Thomson Reuters said.

Johnson & Johnson, which is based in New Brunswick, N.J., said global sales rose 3.9 percent in the quarter, to $16.26 billion, slightly below analysts’ target.

Source : nytimes

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New Data from Britain about DePuy ASR Acetabular Hip Replacement Devices

Is Johnson and Johnson Telling the Truth About the Failure Rate?

Johnson and Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson and Johnson started using the device in the United States in 2005 and based its failure rate on five years of research. However, England has a hip registry dating back well before 2005.

This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson and Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.

Here are the real facts:

- August 2010 - Johnson and Johnson recalled the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a revision.

- April 2011 - Johnson and Johnson agreed to pay $70 million in civil and criminal fines for bribing European doctors to induce them to prescribe their drugs or implant medical devices in patients unaware of their doctors' financial incentives, according to The New York Times.

- May 2011 - The British Orthopedic Association and British Hip Society released data that the DePuy ASR XL hip replacement unit fails as often as 49% of the time - four times more than reported by Johnson and Johnson in 2010.

Based on the evidence there are thousands of patients that appear to be healthy now, yet likely will have complications in the next 3-5 years as a result of the ASR XL device.

U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

The U.S. FDA ordered 21 manufacturers to collect information from patients.

The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
The levels of serum and chromium in patients prior to THR.
The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
The number of patients with pain and biological and psychological symptoms associated with the THR.
The quantity of harmful reaction of body tissues in patients who did not have a revision.
How differences in revisions vary over time after the initial implant?
What demographics have higher metal ion concentrations in their blood?
What demographics have higher risks of needing revisions?
What causes the THRs to fail?

Defective DePuy ASR Hip Implants Should Consider The ARP Wave

Patients With Defective DePuy ASR Hip Implants Should Consider The ARP Wave

By Andre Sullo

SULLO & SULLO, LLP

HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.

Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body’s natural recuperative ability.

The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.

To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.

A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”.

These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.

If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

Combating Chromium and Cobalt Blood Toxicity After An ASR Hip Replacement

By Megan Breckenridge, Staff Writer

SULLO & SULLO, LLP

HOUSTON > If you are one of more than 93,000 people worldwide affected by the recent recall of DuPuy, Inc.’s ASR Hip Replacement System, you may be in more danger than you realize. Countless patients have already come forward with horrific stories of pain and suffering as a result of the defective devices; the most common of which are related to metal poisoning, or metallosis, which is a reaction to the chromium and cobalt metal debris that is shed when components of the device rub together.

If you have experienced symptoms of chromium and cobalt toxicity, which include pain, inflammation, tumors and difficulty walking, it is imperative that you seek medical attention immediately. Specialized blood tests can be used to detect levels of these toxic metals in ASR Hip Replacement patients. In some cases, patients with DePuy ASR implants have been found with 100 times the normal levels chromium and cobalt in their bodies.

One method of treating ASR Hip Replacement patients with high levels of chromium and cobalt in their blood is chelation therapy. The process involves the administration of chelating agents—the most common of which is ethylenediaminetetraacetic acid (EDTA)—to remove the poisonous metals from the body.

Chelating agents may be administered intravenously, intramuscularly, or orally, depending on the agent and the type of poisoning. They bind to heavy metals in the body and prevent them from binding to other agents, creating a compound that can then be excreted from the body.

For many patients, intravenous Vitamin C and replacement mineral infusions are also recommended to support the body through the metal removal process. Symptoms will often begin to improve within weeks of commencing treatment, but some may linger, indicating residual organ damage. Therapy may last as long as six months to two years.

At present, the Food and Drug Administration (FDA) has not approved chelation therapy, though both traditional doctors and alternative medicine practitioners do offer this service. A single chelation treatment usually lasts from two to four hours and costs between $50 and $100. In the first month, patients receive between five and 30 treatments (with 30 being most common), and are often advised to continue preventive treatment once a month.

Individuals must pay for the treatment themselves. Because chelation therapy isn’t a medically accepted procedure, standard medical insurance and Medicare do not cover it. It is believed to be safe for patients of all ages, including children and the elderly, but no scientific data currently exists to support this claim.

Side effects of chelation therapy include a burning sensation at the injection site, fever, a sudden drop in blood pressure, headache, nausea, vomiting, inability to create new blood cells, and mineral deficiencies. Some patients have experienced permanent kidney damage or failure, and deaths have occurred in some chelation studies. Because of the known risks and unknown benefits of chelation therapy, talk to your doctor before trying it as a treatment chromium and cobalt poisoning.

Although a full recovery from chromium and cobalt toxicity is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of metallosis for extended periods. Some of the damage, for instance to the liver or brain, may not be fully reversible, and many find that their food intolerances are never completely remedied. Unfortunately for those affected, only time will tell.

If you or someone you love received a defective DePuy ASR device, it is imperative that you obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the full compensation that you deserve. Call us at 800.730.7607 for a free legal consultation today.

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean? Letter to Hip Makers Mean?The U.S. FDA ordered 21 manufacturers to collect information from patients.

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean? Letter to Hip Makers Mean?
The U.S. FDA ordered 21 manufacturers to collect information from patients.