Faulty hip implants: regulatory failure

Reports about the problems related to a hip replacement system availed by a large number of patients over several years expose the failure of the medical regulatory system and the callousness of the company which marketed the product in the country. The prosthetic hip implant manufactured by a subsidiary of Johnson & Johnson was found to be defective and the company recalled it globally in 2010. Though the company said the recall was voluntary, it was because of complaints from users. The use of the defective implants caused pain and other difficulties for many and some even died of complications from it. It was found that the high levels of chemical debris of the implant caused the problems and many recipients had to undergo corrective surgeries. In countries like the US and the UK, the company had to pay hefty compensation to those who had used the device. 

The situation is much worse in India. The information provided by an expert committee set up by the Union health ministry on the matter is cause for serious concern. In the first place, the details were made public only last week, six months after the report was submitted. No action has been taken on it till now. The details are alarming. About 4,700 patients received the faulty implants in India but over 3,600 of them remain untraceable. The company has said that only the hospitals would have this data. There is no national joint replacement registry in the country, though such a body was mooted many years ago. The Central Drugs Standard Control Organisation (CDSCO) did not take any action in the matter though the problem with the implants has been known since at least 2010. This is gross regulatory failure. Hospitals and doctors should also share the blame for not following up the complaints effectively. 

The major issues to be addressed now are corrective surgeries and the compensation to be paid to the patients. The patients should be traced and remedial action taken without delay. The committee has recommended a base amount of Rs 20 lakh as compensation for each patient. But the company has been ordered to pay up to $1 billion to patients in the US. It should be noted that the Drugs and Cosmetics Act, which covers devices also, does not have a specific provision for compensation in case of malfunctioning, reaction, etc. But the company, which has major business in India, should be forced to pay exemplary compensation to patients. The legal and regulatory inadequacies and failings should also be addressed in the interest of patient safety and to ensure that fair practices are followed by medical companies and others. 

Liked the story?

  • 0

    Happy
  • 0

    Amused
  • 0

    Sad
  • 0

    Frustrated
  • 0

    Angry

Comments:

Faulty hip implants: regulatory failure

0 comments

Write the first review for this !