In the United States, metal implants have led to tens of thousands of lawsuits against the medical device companies that manufacture them

Peter Coyle, a resident of Thompson, Connecticut, believes that his osteoarthritis was completely cured when he underwent hip replacement surgery in 2005.

In order to reduce the pain and stiffness of degenerated hip joints, 67-year-old Coyle implanted artificial metal substitutes. He hopes that the implant will accompany him for the rest of his life. Conversely, 15 years later, Coyle experienced more hip pain as the implant released metal fragments into the surrounding tissues and his blood.

"He was poisoned to death by this metal. [After removing the implant] He had to undergo rehabilitation and physical therapy," said Paula Bliss, a product liability lawyer at Easton’s Judicial Cooperation Organization, and Coyle's lawyer said in a lawsuit filed in the Suffolk High Court on October 5. Defendant Domenic Dinardo and his company DJD Medical Inc. (a clinic in Guangzhou) distributed orthopedic products that allegedly caused Coyle injuries. 

Coyle's experience is by no means an isolated case. Metal poisoning or metal poisoning caused by implants used in hip replacement surgery is nothing new and has been widely reported for more than a decade. In the United States, implants have led to tens of thousands of lawsuits against the medical device companies that manufacture them, including DePuy Synthes (a subsidiary of Johnson & Johnson), Zimmer Biomet, and Stryker. 

But the new situation is that almost every day, 100,000 hip replacement recipients still begin to show signs of disease due to implants they received many years ago. Although dangerous metal hip implants are no longer sold to the public, experts say they cannot predict when or how these implants will cause serious damage to the lives of those who own them. This means that patients are like ticking time bombs, and they don't know when the sequelae of the operation will infect them. 

"There is no rhyme or reason. You can never judge how severe these symptoms affect someone," said Michele Stephan, an attorney at the law firm Maglio Christopher & Toale who specializes in defective medical device cases. Say. "There may be different systemic effects such as hair loss, brain fog, itching, rash, and cardiomyopathy."

Dr. Frank Buttacavoli is a plastic surgeon and clinical associate professor of joint replacement at the University of Texas Health Science Center in San Antonio. He emphasized how patients occasionally experience symptoms. 

"I have seen people [symptomatic] one to two years after [their operation], and some people are okay 15 to 20 years after the operation, but their symptoms suddenly worsen," Buttacavoli said. 

The hip replacement system is designed to mimic the function of a natural hip joint in three parts: an artificial ball and socket joint, a pad between balls and sockets that allow movement, and a stem used as a thigh bone. Depending on the needs of patients, medical device companies will sell individual hip joint components or entire hip joint systems.

Buttacavoli explained that when the ball and socket are both made of metal, these operations can have a dangerous effect because the movement can cause the parts to wear together. This can cause wear debris and release of metal ions from the device into the body. Hip replacement surgery using metal balls is called metal-on-metal or MoM, hip replacement surgery.

"Unfortunately, many people have a significant reaction to metal ions," Buttacavoli said. "You will get something called pseudotumor, which is a local tissue destructive reaction. Unfortunately, it will swallow many important muscles around the buttocks and may cause permanent dysfunction. For those with kidney problems, liver For people with problems or even eye problems, metal ions may become a systemic problem."

According to Coyle’s court records regarding damages and a petition for a jury trial, Coyle implanted a DePuy Pinnacle MoM hip replacement system made of cobalt and chromium at St. Vincent’s Hospital in Worcester. Coyle is suing Dinardo and his medical clinics, collectively referred to as "distributors", because his "injury was caused by [Johnson & Johnson] and distributors' fraudulent, deliberate and/or negligent omissions and misrepresentation of clinical risks and benefits The pinnacle of work." 

After DJD Medical Inc. left several phone calls and voice mails, Dinardo did not respond to the interview request, and because of the continuing nature of the Coyle case, Bliss declined the interview request on behalf of Coyle.

Court records indicate that Coyle did not notice symptoms until 15 years after MoM hip surgery. Frances Scott, a 50-year-old mother of three children, suffers from hip dysplasia and served as a news anchor for the Raleigh, North Carolina TV station, but her luck was hardly so lucky. A few weeks after using the Pinnacle hip system for replacement surgery in 2011, Scott suffered a seemingly endless series of symptoms. First, she said that the dermatologist referred to the blood on her face as middle-aged acne. Before long, Scott began to experience hearing loss, hallucinations, severe mood swings, memory loss, depression, sensory problems, kidney pain, and irregular heart rhythms. 

Scott didn't know what caused her pain. She considered everything. She even thinks she suffers from bipolar disorder. After the symptoms appeared, Scott embarked on a six-year intensive research and investigation journey. In 2018, she finally connected the dots: Just like Coyle, Scott was poisoned. Later, she removed the metal hip implant during a revision operation, and most of her health problems were resolved.

"I still suffer," Scott told The Scope at her home in Austin, Texas. "But the main thing I appreciate most from the revision is that I no longer have mental or neurological problems. I don't feel like a mentally ill person."

Scott made many allegations against DePuy Synthes, implying that the company is responsible for her suffering. These allegations are supported by court records filed in the U.S. District Court for the Northern District of Texas in Dallas on October 3, 2016, where Scott participated in the multi-district litigation trial (MDL) filed against DePuy Synthes. Involving the Pinnacle hip system. Bliss explained that MDL is a way to resolve hundreds or thousands of similar cases in small groups, so plaintiffs like Scott waiting to hear their own cases can understand how it might develop. In this trial, the six plaintiffs received a total of $1 billion in verdicts. 

"The truth is, [DePuy Synthes] knew from the beginning that metal to metal would not work," said Mark Lanier, one of the plaintiff's lawyers in the 2016 MDL trial. "In 1995... Graham Isaac was the development manager of the hip. He issued a memo... in it, he talked about metal-to-metal. He said that it was clear from the literature Out, this is far from satisfactory...a large amount of wear debris is released."

Scott felt that she had finally solved the case. Obviously, the metal ions released by the hip implants into her system are responsible for her physical and mental pain.

But it was too late. The damage has been done. 

The unbearable physical pain combined with the weird and abnormal behavior caused Scott to lose precious time with the children and her job as a news anchor at WTVD in Raleigh, North Carolina. Long after removing the implant, Scott continued to face the consequences of her fatal surgery.

"It ruined my career. Everyone thought I was either crazy or drugged, and I have been suffering," said Scott, who is now a video content creator and patient advocate. "I can't get my previous job because as a 50-year-old news anchor, I don't have the same market as when I was 30."

Scott's metal-on-metal hip replacement surgery destroyed the life she knew. But for Carol Mayer, a 75-year-old former physical education teacher from Englewood Cliffs, New Jersey, hip replacement surgery has been-and will continue to be-an aspect of her life for more than 30 years. .

Mayer has performed a total of 3 hip replacement surgeries in her life, and she plans to perform two more. The first surgery she completed in 1991 was a metal-to-metal hip replacement. In 2015, Mayer needed revision surgery because blood tests showed that the metal ions in her blood reached toxic levels.

"I started to limp, and I started to show signs that I had never had an operation," Meyer said. "My gait is not what it used to be, I am absolutely uncomfortable."

Unlike Coyle and Scott, Mayer believes that there is no need to take legal action for the pain she faced due to metal-to-metal surgery. Mayer said that when she started the operation, she knew that the implant would not last forever and might need to be removed. With the threat of revision surgery looming, Meyer maintained an optimistic attitude to deal with the uncertainty.

Meyer admitted that despite her optimism, she is no longer the same person before the operation. In order to curb the need for more revision surgeries in the future, Meyer sacrificed some meaningful hobbies, namely squash.

"[Playing a ball] is not a good idea, because lateral movement is bad for the hip joint, it can perform a hip replacement and take it out of the joint socket," Meyer said. 

In most cases, patients like Mayer, Coyle, and Scott only realize that they need to remove the metal implant when they develop symptoms. Stephan said that patients can be proactive by checking the level of metal ions in the blood every year.

"The longer the metal is stored, the more susceptible the plaintiff is to damage," Stephen said. "The plaintiff's future depends entirely on the severity of the injury. If they are lucky enough to find it early, the patient can recover."

Buttacavoli said that even regular testing is not a foolproof method to detect metal diseases, which actually puts the patient's fate in the balance. 

"[Patients] can often get to the laboratory. But laboratory research is usually not completely related to the formation of pseudotumors," he said.

Experts explained that the implants currently sold by medical device companies like DePuy Synthes use a combination of metal, plastic, and ceramic components, rather than pure metal substitutes. Therefore, metal-to-metal hip replacement systems almost no longer exist in the medical device market. 

However, the shadow of metal implants looms over the lives of patients, and these patients are always likely to undergo metal degeneration and require revision surgery. The patient can never be sure when the symptoms will appear, and the patient can only deal with the potentially devastating consequences on their own.

"[Johnson & Johnson] made billions of dollars," Scott said. “At the same time, we are watching our liquidity decline, watching our health decline, watching our families need funds and we can’t take care of them.”

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