However, three months after Lu’s report, Birbas told staff in another email that the “jury had not decided” what caused the fractures. The company would only recommend a replacement if a patient was heavy or led an active lifestyle. Others would keep the part.
Another internal email says it was easier to remove the bicones before they broke.
The Therapeutic Goods Administration (TGA), which regulates medical devices, became aware of the above-average number of fractures in 2018 and approved the company’s action. A spokesman said this week the part remained “fit for use” but urged the company to send additional information to patients.
Attorneys for Al Muderis told Age and The Sydney Morning Herald in a statement that all complaints had been investigated and dismissed by regulators. Lawyers said bicones need to be replaced regularly and that patients are responsible for the maintenance of their parts.
“Some amputees resume very active lifestyles after osseointegration surgery. Some patients break their bicones due to excessive activity. Some patients are resuming horseback riding, hiking, jogging and swimming, and there have been patients who have even taken up skydiving,” the statement said. “Professor Al Muderis cannot restrict patients’ activities, even though he advises them not to engage in high-impact activities.”
However, the selective replacement approach has been privately criticized within the company’s medical team, including by US surgeon Solon Rosenblatt, who in a private correspondence with colleague Fred Hernandez accused the company of putting profits ahead of patients.
“[Their] THE ONLY loyalty is to MONEY,” Rosenblatt said in a text message.
In an October 2018 email, he wrote: “For a time, ALL patients who received a Type B implant were sent a new reinforced double cone from Bres Medical with instructions on how to replace the old one… But it was too expensive.” become, so [the company] decided to only replace these bicones when they broke!”
When asked if there were negative findings against the part, Al Muderis said Age, The Sydney Morning Herald and 60 minutes: “Not to my knowledge.” He said he insisted the company replace the faulty cones and “there have been no failures since.”
US patient Chris Bruha received the defective part in July 2017. The company sent him a replacement part six months after his operation. The following year, that too broke.
“It just snapped and I went down,” Bruha said. “I’m a retired firefighter, so getting beat up isn’t a big deal. But it’s just annoying when you take a step and there’s nothing there.”
Bruha paid $150,000 for his osseointegration surgery but said he received limited support when the bicone broke. His friend, who had no medical experience, replaced the parts in a painstaking process that took more than five hours. Later Bruha received a bill.
“They sent me a bill for the bicones, both of which I just left and ignored,” he said.
Rosenblatt filed an official complaint with the medical regulator, the Australian Health Practitioner Regulation Agency (AHPRA), in December 2018. The complaint said Al Muderis had “put the public at risk of harm” by practicing in a manner that “represents a material departure from accepted medical standards.”
Rosenblatt claimed the implant was not tested adequately before being used in more than 100 patients from Australia, the UK and the US.
“Some of the implants broke. The own research advisor of Dr. Al Muderis suggested that the part of the implant that could be changed should be changed as soon as possible,” Rosenblatt wrote to the regulator. “Fortunately, none of the patients who experienced a ruptured implant were seriously injured.”
AHPRA was contacted for comment.
A TGA spokeswoman said after receiving the 2018 complaint, the regulator launched an investigation and later issued a safety alert, “reminding patients of the two-year lifespan of the prosthesis and the need to regularly inspect all components.”
The Osseointegration Group of Australia told TGA that it stopped using the failed part in February 2019 – 10 months after Lu’s report called for immediate action.
Rosenblatt confirmed this Age, the herald and 60 minutes The defective bicone was used in patients until a replacement was constructed.
“We have told patients that we are working on a new design; we do not have any yet. We don’t have anything better, but of course you want to keep running,” he said. “I [didn’t] have no choice but to reinstall another type B double cone.”
Al Muderis said he was not responsible for the fractures. “I’m a clinician. i am a surgeon We need to separate here between the design side and the manufacturing side… I own the patent. I designed the parts, but I wasn’t the engineer.”
Patients who received the faulty part were given a replacement part made by Bresmedical, which Birbas says was “made with extra strength for patients who are at risk of having their bicone damaged”. Some patients expressed concerns about the replacement parts.
In an open letter to patients, Birbas criticized those who questioned the process.
“Ultimately, a surgeon would use clinical judgment to determine which implant would be best for a patient,” he said in a memo to patients.
“Typically, a patient has neither the clinical knowledge nor the experience to ask a doctor which medical device is right for them.”
Christopher Rudge, a health law expert at the University of Sydney, criticized Birbas’ response, saying it violated patients’ right to transparent and informed treatment. “That’s a big red flag,” he said.
Al Muderis rose to fame as an Iraqi refugee turned high-profile surgeon. He was named 2020 NSW Australian of the Year and GQ Man of the Year for his contribution to medicine and refugee advocacy.
The Morning Edition Newsletter is our guide to the day’s most important and interesting stories, analysis and insights. Sign up here.