Women Possibly At Higher Risk for Medical Device Failures?

“Are women more likely to be harmed by medical device failures?”

By: Ben Hallman https://www.icij.org/blog/2018/12/are-women-more-likely-to-be-harmed-by-medical-device-failures/ For the last year, the International Consortium of Investigative Journalists has been investigating the medical device industry around the world. They found that there are very relaxed regulations in the implant industry, which allows dangerous products, like metal on metal hip replacements, to be implanted into millions of patients. The investigators were particularly shocked at the number of dangerous devices that were marketed towards women. After their extensive investigation into the implant world, they found that  “women were disproportionately harmed in many of the scandals that have plagued the industry.” Women are now banding together into interest groups and demanding that regulators do more to protect them from dangerous devices because women are more likely to experience complications from medical devices than men. The authors discuss the shockingly high failure rates of female-specific implants. However, the authors found that women face more complications than men using the same exact implants. This is especially true for hip replacements. For instance, the failure rate for hip implants in women is 29% higher than that of men. Additionally, women are more likely to suffer from hypersensitivity to metal used in hip implants. This, according to the authors, happens for many reasons. First, clinical trials don’t include enough women. Second, doctors don’t always believe women who claim their devices are harming them. The authors discuss several stories where women expressed that they believed their implants were causing them problems, but their doctors did not believe them.
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Victims & Medical Professionals Not Warned of Product Failures

Article link: https://www.icij.org/investigations/implant-files/hidden-dangers-patients-doctors-not-informed-of-defective-implants/

Article title: Hidden Dangers: patients, doctors not informed of defective implants

By Spencer Woodman

This article begins with the story of Vijay Vojhala, an Indian man who received a Johnson & Johnson metal-on-metal hip in 2008. Vojhala’s implant was the DePuy Orthopaedics ASR hip system.

In 2011, Vojhala went to a medical product conference and found out that his hip replacement had been recalled in a handful of countries, including the U.S., over a year ago.

Soon after, Vojhala found out that his implant had shed metal particles that infiltrated his bloodstream. Vojhala now has a limp and cannot work. His implant has a failure rate over 50 percent.

The article explains that the problem Vojhala had was due to the fact that, in many cases, medical implants are recalled or even banned in some countries, but they remain on the market in other countries. Additionally, it is very difficult for hospitals to locate patients who have received recalled implants.

After Vojhala’s hip was recalled around the world, it took India’s health authorities over three years to notify hospitals. By that point, Johnson & Johnson and India’s hospitals had lost track of who had received the hazardous implant.

Johnson & Johnson claimed that patient privacy laws prevented them from directly reaching out to patients who received their metal-on-metal hips.

Johnson & Johnson also claimed that they posted recall information on their website and hired third-party companies to tell patients that their implant had been recalled.

The article then goes on to explain that, when medical products are recalled, the process for notifying the public is not always effective. Sometimes a recall only requires labeling changes, and other times, a recall might require a product to be completely removed from the shelves. In other cases, manufacturers will stop sales after a recall but won’t admit any wrongdoing. Governments can also ban the sale of certain devices without even recalling them.

The author’s investigation found that there was no global database to search for device recalls, so the journalists of the ICIJ made one. ICIJ’s database shows any implant that has been recalled or deemed dangerous in any country. They hope this resource will make it easier for patients to find out when their medical devices have been recalled in other places around the world.

A major problem the ICIJ found is that sometimes a product will be recalled in some countries but not others. One example of this is a metal-on-metal hip produced by Biomet. After studies found that Biomet’s implant was causing metallosis – a type of metal poisoning that affects internal tissue – Biomet notified doctors in Australia, the UK, and other countries in Europe. But they did not notify any doctors in Canada or the US. The authors state that if the FDA had tried to recall the implant, American doctors would have known about the recall too.

The investigators interviewed a 43-year-old American man named Andrew Chappell, who had a Biomet metal-on-metal hip implant. At a doctor’s appointment, Andrew found out that his implant was injuring his bones. The implant eroded his bones so much that his femur cracked during a surgery he received in 2018, three years after Biomet’s implant was recalled in other countries.

Zimmer Biomet (the new official name for Biomet) did not respond to the journalist’s questions about the global recalls. The company simply stated that they “adhere to strict regulatory standards” and are “commit[ted] to operating a first-rate quality management system” around the world. They also stated that they work closely with the FDA.

When the journalists asked the FDA why they hadn’t recalled the Biomet hip even though other countries recalled it, the FDA said that they posted a general safety notification about metal-on-metal hips on their website in 2011. They said that, because they posted that notice online, they didn’t have to recall the Biomet hip.

Could we somehow fix the worldwide gaps in medical device recalls? It turns out there are efforts around the world to streamline and improve how patients are notified of implant recalls.

The investigators interviewed Harold Paz, the vice president of Aetna, a major US health insurance company. Paz is advocating for a system that would track patients who are implanted with medical devices like metal-on-metal implants. This would make it easier to inform patients when their devices are recalled. Paz believes that if automobile manufacturers can keep track of their owners, then medical providers should be able to keep track of patients who receive medical implants.

They also interviewed Carl Heneghan, a health researcher in the UK. He said that databases to track joint replacements have taken off much faster than databases for other types of medical devices, most likely because of the high failure rate of joint implants like metal-on-metal hips.

However, this is really only true for the UK and Canada. The US and India, for example, have not really taken steps to track joint implants through device registries. However, after the Johnson & Johnson hip implant scandal, the Indian government “is considering implementing its own implant registry.”

On that same note, the authors spoke with Dr. Henrick Malchau, an orthopedic surgeon from Sweden who has been pushing to create worldwide implant registries. He said Australia’s implant database was the reason government health agencies figured out that Johnson & Johnson’s hip implant was dangerous. The information from the database was also instrumental in notifying patients and doctors of the device’s hazards. Because the database tracked all the patients who received implants, it was easy to let them know that the metal-on-metal hip was dangerous.

In closing the article, the authors revisit the story of Vojhala, who received the hazardous Johnson & Johnson hip implant in India. He says that better systems to notify patients about implant problems are “badly needed.” To this day, Vojhala suffers from decreased mobility, vision problems, and heart problems because of his implant. These health complications have left him unemployed. He says that if he had known about the recall when it first happened, he could have avoided the complications and “a lot of pain.”

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European Lobbying Impeded on Safety of Medical Devices

Article Link: https://www.icij.org/investigations/implant-files/how-lobbying-blocked-european-safety-checks-for-dangerous-medical-implants/

Article Title: How lobbying blocked European safety checks for dangerous medical implants

By Simon Bowers

In recent years, there have been two major attempts to increase safety regulations for medical implants in the European Union. However, lobbyists have shot down both of these reform attempts by misleading policymakers about their products.

Public health spokespeople criticize the European Union for its lax regulations and speedy approvals of medical implant devices. As proof of this, they point to the fact that “the EU has borne the brunt of many of the world’s worst implant scandals,” which have caused patients to suffer and even die because of their implants.

The Implant Files is a year-long investigation that involved over 250 journalists around the world. Their extensive investigation found that medical technology has advanced very quickly, but the laws surrounding them have not kept up. As a result, patients with medical implants have suffered from faulty devices entering the market too quickly.

Experts have found that the time it takes to approve medical products in the US has gotten shorter and shorter, which has created massive profits for medical device companies.

It’s even easier and quicker to get products approved in Europe, which has “some of the lightest regulations in the developed world.” Medical device lobbyists based out of Europe have encouraged other countries, including the United States, to adopt Europe’s relaxed policies.

These trends apply to all sorts of medical devices, including metal-on-metal hip implants, which have been some of the most controversial medical products to hit the market in recent decades.

Jurgen’s hip

Because the laws are so relaxed in Europe, medical device manufacturers like to introduce their products in Europe first. Once their products have been approved in Europe — which acts as a stamp of approval for the rest of the world — it is much easier to get them marked as safe for consumption in other countries.

The article tells the story of Jurgen Thoma, who was 48 when he received a metal-on-metal hip implant in Germany. His implant, manufactured by Zimmer Biomet, had not been approved by the FDA when he received it in 2005.

Europe legally classified Zimmer Biomet’s product as “safe for use” two years before Jurgen’s surgery, in 2003, despite not having a single human study testing its product. European laws did not require Biomet to test their implant on humans before marking it safe for consumption.

Thoma said that the hip implant quickly became painful. In 2009, just four years after getting his implant, Thoma had to get a revision surgery to replace his device. The surgeons found that the implant was shedding metal debris. As a result, his bone became spongey, soft, and grey. Thoma said his bone looked like Swiss cheese.

Thoma said that, because of Europe’s poor safety standards, he felt he had become the “guinea pig” for the product.

He decided to sue Zimmer Biomet in 2010. In 2018, a judge in Germany declared that the Zimmer implant “should not have been put on the market,” and Thoma received only $28,600 for his injuries at the end of the eight-year legal battle. Zimmer has since denied any problems with their product and appealed the court’s decision.

That being said, the article states that Thoma is relatively lucky because European laws tend to protect manufacturers over consumers.

Scandals and Loopholes

The article goes on to talk about a 2010 scandal involving metal-on-metal implants. Many metal-on-metal implants were pulled from the market as people began to realize that they were failing at extremely high rates.

As the scandal unraveled, a group of journalists went undercover, posing as metal-on-metal hip device manufacturers, and visited EVPU. EVPU is a Slovakian firm that the government has put in charge of testing whether products are safe for use in the European Union.

The journalists presented the EVPU with a mock-up drawing for a fake metal-on-metal hip implant, which was designed to be identical to a hip implant that had already been recalled. The EVPU approved the fake hip design. The exchange exposed blatant corruption and carelessness in medical device regulation.

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