Defective Medical Device Victims Speak Out

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Article Link: https://www.icij.org/investigations/implant-files/patients-fight-for-answers-as-broken-implants-cause-unseen-agony/

Article title: Patients Fight For Answers as Broken Implants Cause Unseen Agony.

By: Spencer Woodman

This article highlights the heartbreaking stories of patients around the world who received faulty medical device implants.

In doing so, they interviewed Jeong Sang-Ho, a 47-year-old from Seoul, South Korea, who is currently embroiled in a years-long lawsuit against Johnson & Johnson over a faulty implant he received in 2008. Jeong originally received Johnson & Johnson’s ASR metal-on-metal hip system in 2008.

Jeong experienced great suffering as a result of his defective DePuy ASR hip implant. The implant dissolved inside of his body, which led to a number of devastating consequences, each one worse than the other. Jeong recalls that, as the implant began to disintegrate inside of him, “the device [pierced] into [his] thigh, which caused [him] to bleed a lot, and it felt like there were a thousand needles poking into [his] leg.”

In 2010, Jeong went in for a hip revision surgery, where his broken implant was replaced with a new ASR implant. Two months after his surgery, Jeong’s new implant was recalled, but he did not find out about the recall until 2013.

As a result of the ASR implants, Jeong is disabled and lost his job. He has spent the last few years fighting Johnson & Johnson in court, but he has only received a meager $600 of compensation from the company through Johnson & Johnson’s ASR Reimbursement Program.

In 2016, a United States federal judge ruled that Johnson & Johnson had to pay $1 billion to Americans who received one of Johnson & Johnson’s other faulty metal-on-metal implants. However, being in South Korea, Jeong is not entitled to the same compensation as Americans.

To this day, Jeong still has the ASR system in his body. Johnson & Johnson has also appealed the 2016 ruling requiring it to pay $1 billion to patients injured by the ASR system.

In a video embedded in the article, Jeong states, “This device ruined my life. I lost my job. I have great limits in exercising every day. I can’t lift up heavy things or even hold up my baby.”

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The article also tells the story of Connie Hill, a 72-year-old American woman who received a Zimmer Biomet metal-on-metal hip implant.

In 2015, Biomet issued a safety warning for the implant in Australia and later published similar warnings in countries throughout Europe. Biomet issued the warning after doctors found it was causing “an array of disabling complications.” However, Biomet never published a safety warning in the United States, so Connie and her doctor were never notified of the Biomet device’s hazards.

Connie had no idea there was anything wrong with her implant until late 2017 when her doctor noticed that the bone around her implant was starting to dissolve, and she had very high levels of cobalt and chromium in her blood.

The authors of the article point out that the FDA published a “generalized safety communication” about Biomet hip implants in 2011, but the FDA never directly reached out to doctors and patients who had worked with or received the implants.

Connie’s implant had to be replaced. Before she went into surgery, the doctors warned her that she could suffer a variety of debilitating complications, including death. Thankfully, Connie’s revision surgery went smoothly.

The authors of the article suggest that Connie’s experience was a result of a larger problem in the medical device industry: medical device companies sometimes send out safety alerts in some countries, but not others.

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A video embedded in the article also tells the story of Vijay Vojhala. Vojhala lives in India, and he received metal-on-metal hip implant in 2008. His implant was recalled in 2010 after it “poison[ed] thousands of patients.”

As a result of the implant, Vojhala had to remove all of his dentures, is deaf in one ear, and has a myalgia problem. He states that, when he tried to talk to the surgeon who gave him the faulty implant, the doctor had no idea the product had been recalled.

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