All-Metal Hip Replacements: Not All Patients Informed of Recall

British orthopedics officials have written surgeons, fearing not all patients who got “metal-on-metal” hip replacements know they were recalled.

The British Orthopaedic Association has notified surgeons because they are concerned some of the 40,000 patients who got “metal-on-metal” hip replacements never got the recall notice.

Professor Joe Dias, the association’s president, told The Sunday Telegraph the letters said the records held by DePuy — a subsidiary of Johnson & Johnson — show that just over one-third of the patients with the devices were recorded as having participated in the recall.

Dias said it was possible other patients had been contracted by hospitals and undergone checks, without their details being centrally logged but that he was concerned some patients were never contacted.

The surgeon said private hospitals and large National Health Service units seemed to have been thorough in contacting patients, it was less clear if small NHS units had.

“My worry would be about cases where surgeons have retired, and no-one is following up on the patients they treated,” Dias told the Telegraph.

The implants’ manufacturers cannot contact patients directly, because they do not have access to their records.

The metal-on-metal implants were considered stronger and were often given to younger patients, but friction between the metal ball and cup causes minuscule metal filings to chip off and seep into the blood causing inflammation, destroying muscle and bone, Dias said.

There are concerns fragments containing cobalt and chromium could put the kidneys and other organs at risk. In 2010, patients were told to be checked annually for at least five years.

Copyright 2012 United Press International, Inc. (UPI). Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI’s prior written consent.

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By AKSHAYA B S: Subscribe to Akshaya‘s RSS feed

January 30, 2012 6:02 AM EST

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It now has to be revised because of AVAL damage.

Is there a firm of solicitors acting for a group claim for Birmingham hip revision surgery because of AVAL damage?

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in this article the medical “authority says only DePuy metal on metal hips are a problem (abridged)” – BUT AS ALL readers of this blog will know – Smith & Nephew BHR and other Metal on Metal devices have the same problems – the FDA has had over 500 complaints for faulty Smith & Nephew BHR’s according to the FDA website.

This is a metal on metal problem whether hip resurfacing or total hip replacement (as I had).

Time for the other big companies to recall their devices and face the music as J&J’s DePuy has had to – albeit belatedly.

Kiwis told of implant poison risk

JODY O’CALLAGHAN

About 500 Kiwis have been told their metal hip replacements may be poisoning them.

The “metal-on-metal” implants were withdrawn from the worldwide market in September 2010 after they recorded a higher than expected failure rate.

Tiny metal fragments were found to be breaking off and leaking into the blood, poisoning it.

Muscle and bone became destroyed, leaving patients in pain and sometimes making further surgery more difficult.

However, in more than a year since the recall, only about 20 out of 507 New Zealand patients who received the device have had a partial or complete replacement.

A new report from British senior surgeons has described the situation regarding all metal-on-metal hip replacements as “frightening”, given the number of patients now suffering tissue reactions amid “component failure of catastrophic proportions”, London’s Daily Telegraph reported.

One New Zealand patient who has had his implant replaced is now calling for a parliamentary select committee investigation into the problem.

James Elliott had his hip replaced with a metal-on-metal joint when he was 43, he told TV3. It was replaced in 2010 after problems with the metal components were first reported.

He said there should be a “high-level” government inquiry into how the parts came to be used in New Zealand.

But Orthopaedics Association president Bryan Thorn said the problems lay only with one particular product, made by Johnson & Johnson subsidiary DePuy, and that metal-on-metal replacements were still suitable for some patients.

In the five years to June 2011, 507 patients received a DePuy device and 18 of those were recalled for partial or complete replacement, he said. He was aware that more had been redone since, but the numbers were low.

A national joint registry, established in 1999, gave detailed information about each replacement carried out and allowed easy contact in the event of a recall.

The association ensured all orthopaedic surgeons were well informed of the DePuy issue and patients were given the opportunity to have the product replaced, Mr Thorn said.

Meanwhile, a monitoring programme was checking levels of iron in patients’ blood.

He said the cost of a second operation and any compensation claims were a matter between patients and DePuy. Metal-on-metal hip replacements can cost between $30,000 and $40,000.

DePuy spokeswoman Melissa Tyndale-Biscoe said the company regretted the impact the recall had on patients, their families and surgeons.

It was now providing support for more than 4000 patients in New Zealand and Australia.

X-rays and other scans, travel, and temporary home care after surgery were also among the costs that would be covered for patients who needed them.

Health Ministry spokesman Kevin McCarthy said Britain’s Medicines and Healthcare Products Regulatory Agency had not issued a statement about the DePuy product, so the ministry was unaware of any hard data about its risks.

MEDICAL HELPLINE

DePuy is encouraging concerned patients to contact the ASR Helpline on 0800 660 026 to register and have their questions answered, or speak to their surgeons. Further information can be found at asrrecall.depuy.com.

More on those details later, after toxicology tests and and MRI.

Meanwhile, Here’s today’s new from the UK:

http://www.topix.com/health/hip-replacement

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I have a large lump on my buttock full of toxicity.

I have become rather cross at the medical profession’s economical dispensing of the truth.

I have been told that I may wake up minus a hip and that makes me even more angrier because this should have been dealt with two years ago, when a scan showed fluid around the hip.

Thank you for all the info on your blog – it has been a great help.

Regards

Pauline

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Hi Earl I have just been to my hospital for an x ray as they have told me that they are recalling all their birmingham hip patients to test chromium and cobalt levels in the blood. I am still waiting for my results. I had my BHR Smith& Nephew fitted in November 2007 and have been doing some research and have found that S&N have recalled some patients and they have recalled certain acetabular cups and sent out this following letter to the hospitals:

Dear Customer,
Smith & Nephew have been informed that the above devices may have been miss – labelled. The product packaging for the notified complaint was for a 54 mm BHR Acetabular Cup, however inside was a 50mm Acetabular Cup. One more device has also been positively identified as being the reverse of this.
An evaluation has been performed in -house and has determined that the devices are likely to cause a risk of adverse health consequences to the patient through the necessity for revision surgery. Due to the mismatch in size of the Femora l and Acetabular devices this may lead to elevated metal ion levels and or metallosis. Smith & Nephew are therefore recalling the above mentioned pro ducts to physically verify their status.
A number of the devices in the table below have been identified as being implanted. Smith & Nephew have contacted all of the surgeons and Hospitals which are affected by this recall. This will enable Smith & Nephew and the surgeons involved to review the patient X- rays and verify the status of the se devices.

The Medicines and Healthcare Products Regulatory Agency have been informed of this recall.

This is particularly alarming as this letter was dated June 2007 yet my hip resurfacing was performed in November 2007 and yes I was fitted with a 74120150 faulty labeled acetabular cup. I am now looking at having a revision and do not even know the best thing to replace it with. Also I am actively still playing netball and have been told if you have a full hip replacement they are normally only expected to last about 10-12 years and if you continue to do sport it can reduce the longevity of your hip replacement by many years and that you can only have a maximum of two revisions not that I can face having even one.

I am really fed up and want to also know how I find out if there are any class actions already against Smith & Nephew?

Alison (age 50) from the UK

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I personally had a Birmingham hip implant (Smith & Nephew) in February 2008 and started with extreme pain after a short time due to the pseudo tumour from the metal on metal unit.

I am male 64 and the reason for the initial operation was Perth’s disease from the age of 8 Years old. The NHS performed many tests including MRI,X-rays,CT scans, Ultasonic scans and even a ultrasonic guided injection over the next three years and finally the consultant agreed to give me a revision operation in October 2010.

After a prolonged wait and increasing pain I rang the PCT NHS after 23 weeks and told them that under article 56 of the EU Convention I had the right to go to another country and that they would have to pay.

I found a hospital and surgeon in Lille, France who specialised in metal on metal replacements and also is an expert in bone restructuring who was also doing tests on the prostheses recovered during his operations. I elected to go to his hospital and pay up front allowing the doctor to rid me of the pain.

He told me that the tumour was 150mm on the old prostheses and it was a very difficult operation. He also told me that the tumour was attached to many blood vessels and had the tumour burst while I was on the operating table the contents of the tumour would have gone around the whole body and if it was not benign I would have died within 48 hours and he would not have been able to save my life.

It is time that Smith & Nephew were responsible enough like the American Depuy company to accept that the metal on metal is wrong and should be prepared to accept the consequences.

If they can not, then the British Government should make them take responsibility.

I had the revision operation in April 2011 and am still in pain but it is decreasing very slowly or if not I am getting used to the level of pain still.

Harold

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• View Video

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Download Complimentary Source PDF 

Prominent researchers who allow themselves to be listed as authors of ghostwritten journal articles could find themselves in a world of legal hurt, an essay in PLoS Medicine argued.

If the articles include false or manipulated data on marketed products, “guest authors” could face litigation under several federal statutes, according to Xavier Bosch, MD, PhD, of the University of Barcelona in Spain, and two U.S.-based colleagues.

They suggested that such lawsuits may be the last hope for putting a stop to ghostwriting in medical journals.

“Stakeholders, including universities, journals, pharmaceutical companies, and academic key opinion leaders, have largely failed to heed public calls for honesty in reporting clinical research. Since these complaints have fallen on deaf ears, we believe the courts now have the task of restoring the integrity of the medical literature,” Bosch and colleagues wrote.

Three types of litigation could be pursued against the nominal authors of ghostwritten articles, they indicated — although, in each case, the articles must contain false or misleading information for lawsuits or prosecution to succeed.

One type of litigation involves individuals suffering adverse effects from medical treatments described favorably in such articles suing for personal injury — or when outcomes are fatal, families could sue for wrongful death.

According to Bosch and colleagues, such cases could be winnable if, for example, the ghostwritten article describes a study in terms that omit primary endpoints showing poor efficacy or safety and instead emphasize more favorable post-hoc outcome measures.

“We argue that when an injured patient’s physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then … the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants,” Bosch and colleagues wrote.

A second form of vulnerability relates to the federal False Claims Act, if — as has typically been the case — the misleading ghostwritten article was funded by a pharmaceutical company.

To the extent that such articles are used to support payment of insurance claims, off-label prescribing, or inclusion in drug formularies, the False Claims Act comes into play, Bosch and colleagues argued.

A guest author could be considered a conspirator under the law, they noted.

And if the guest author receives payment for allowing his or her name to be used on such an article, then the Anti-Kickback Statute could apply.

This law makes it a crime for prescribing physicians to take payments for “induc[ing] … the prescribing, purchasing, or recommending of goods or services reimbursable by any federal health care program,” according to Bosch and colleagues.

They contended that the same law could also be used against authors of misleading journal papers, including guest authors.

Neither these authors nor the drug-company sponsors can hide behind the First Amendment, Bosch and colleagues added.

“The U.S. Supreme Court has firmly held that ‘the First Amendment does not shield fraud’ and courts have consistently rejected such First Amendment arguments in cases in which drug companies have been sued for fraudulent or off-label promotion,” they wrote.

Although most of the documented cases of pharma-sponsored ghostwriting occurred in the 1990s and early 2000s — brought to light in the course of product liability litigation — Bosch and colleagues asserted that they had created a “crisis of credibility” that persists to this day.

“The situation is so dire that the public is forced to seek judicial intervention to curb dangerous, unethical medical ghostwriting,” they concluded.

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