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CONCEPT – FAILURE OF JOHNSON AND JOHNSON METAL PROSTHETICS
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- Hip replacement: The hip joint consists of a ball and a socket, which are covered with cartilage and surrounded by a lubricating membrane to protect against wear. In total hip replacement, all components are replaced with prosthetic components. While a metal stem is placed into the hollow centre of the thighbone (femur), the prosthetic ball, socket and cartilage can be made of strong plastic, metal or ceramics. The commonest hip implants are metal on polythene, and ceramic on polythene.
- Current controversy is regarding metal implants: These are metal on metal, with cobalt, chromium and molybdenum as major constituents. Called ASR (Articular Surface Replacement) XL Acetabular System and ASR Hip Resurfacing System, these were manufactured and sold by Deputy International Limited (DePuy), UK, a subsidiary of Johnson & Johnson.
- Problems with these: When the prosthetic ball and socket rub against each other, it causes wear. If the implant is metal on metal, this can sometimes releases metallic debris into the bloodstream. This can lead to complications, sometimes requiring revision surgery. Of the 93,000 patients implanted with ASR worldwide, many experienced serious adverse reactions, some requiring revision surgery to replace the ASR implant with another kind. Because of this, the company recalled the product on August 24, 2010. But it continued in India, unabated.
- Extent of damage in India: The company got the licence to import the device in 2006. By the time it was recalled worldwide, an estimated 4,700 ASR implants had been done. The Health Ministry set up an expert committee in 2017 to examine it, headed by Dr Arun Kumar Agarwal. The committee reviewed action taken by the company to replace faulty ASR implants, and reviewed compensation provided to those who had suffered.
- The first alert: The first red flag had been raised in 2010, when the Maharashtra Food & Drug Administration (FDA) got an anonymous complaint about a patient suffering a serious adverse reaction, leading to an FDA investigation and an FIR. In 2012, the state FDA asked the regulator CDSCO to cancel the firm’s import licence for not taking proper remedial measures or creating awareness about the “defective”. CDSCO cancelled the product’s import and marketing in 2012, then issued a medical device alert on ASR implants in 2013.
- Recommendations of the Expert Committee:
- Pay at least Rs 20 lakh to each patient with complications, and the reimbursement programme be until August 2025
- A central expert committee and a regional expert committee should be constituted by the Ministry for evaluation of patients’ claims in “respect of disability and suffering caused due to use of faulty ASR”
- With 3,600 patients yet to traced, the “firm has to give due diligence to trace those remaining patients who have received ASR but have not registered with the helpline”
- Health assessment of patients should be reported once a year till 2025 and compliance report periodically, preferably six-monthly, submitted to the Ministry. Follow-up should be done regularly
- An independent registry should be established for tracking usage of high-risk medical devices. Provisions for compensation should be included in Medical Device Rules if any serious adverse event or death is caused due to the sole use of a medical device.
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SHOCKING FINDINGS OF THE EXPERT COMMITTEE
SHOCKING FINDINGS OF THE EXPERT COMMITTEE
- A hip implant is usually considered to last up to 15 years. However, data showed that 32 % of patients, who reported adverse events and underwent revision surgeries were in the age group of 40-50.
- Young and old: 20 % of the patients, who underwent revision surgeries, were under the age of 40 years; and the youngest patients to report adverse reaction were two 32-year-old males.
Silent doctors : In the majority of cases, doctors have remained silent on the revision surgery. But, two doctors explicitly remarked saying they believe that “the event is device related”. - Symptoms: The symptoms reported due to adverse reactions are: severe pain, difficulty in walking, limping, metal debris on both hips, osteolysis (destruction of bone tissue) and hip replacement component loosening.
The reason for revision cited are: revision done due to patients experiencing pain and difficulties in walking; revision has been done due to reaction metal debris in both hips; revision has been done as pain started developing “radiolucent line along the side of an acetabulum”.
27 male patients reported adverse reactions and underwent revision surgeries; six were under the age of forty and all of them underwent revision surgeries in 2014; seven patients were in the 40-50 age group; three underwent revision surgery in 2013 and four in 2014; 12 patients were in the 50-60 age group; six underwent revision surgery in 2014, two in 2016 and three in 2017; and two patients were in the 60-70 age group and had revision surgeries in 2014. - 16 female patient reported adverse reaction and underwent revision surgeries: two patients were under the age of forty; four patients were in the 40-50 age group; two patients had revision surgeries in 2014 and two other patients underwent revision in 2017; four patients were in the 50-60 age group; one patient had revision surgery in 2013, two patients in 2014 and the remaining patient underwent revision in 2017, and six patients were in the 60-70 age group and underwent revision surgery in 2014.
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