Taking forward the process of reimbursing patients who were implanted with the metal-on-metal ASR XL Acetabular Hip Replacement System (ASR) in India and require revision surgeries, Johnson & Johnson Pvt Ltd, India (an affiliate of US-based healthcare company Johnson & Johnson) has till date assisted with providing support for around 190 revision surgeries out of 930 patients registered on the ASR helpline. These 930 patients account for 1,120 hip surgeries that were performed between May 2004 and August 2010.

To provide patients and surgeons with the support and information relating to voluntary recall of ASR hip implant, Johnson & Johnson India set up the ASR helpline in September, 2010 following a hip implant recall globally in August 2010. Independent Claims Processor, Puri Crawford Chennai was engaged as the official service provider in India to assist patients in reimbursement of reasonable and customary costs for testing and treatment including revision surgery, if required as well as other out-of-pocket expenses.

"In line with Our Credo, we are committed to addressing patient costs for recall-related testing and treatment, including revision surgery for ASR patients who may require it. Not all ASR patients require the revision surgery. All those who have registered on the ASR helpline are being monitored in a proper manner," said Sushobhan Dasgupta, managing director, Johnson & Johnson Medical India.

From the time of the recall, Johnson & Johnson has supported ASR patients in India with a reimbursement programme for their medical costs, including revision surgery where necessary.

The company encourages all ASR patients in India to register with this programme (0008006501713 for TATA subscribers; 0008006500226 for Airtel subscribers; or +91-44-42144842). It is to make sure as many ASR patients in India as possible are aware of the recall and understand the support available to them.

Patient outreach efforts in India

According to a J&J Spokesperson, "ASR patient data is available only from surgeons and hospitals. DePuy Orthopaedics Inc has been actively requesting that surgeons and hospitals to reach out to their ASR patients and register on the ASR helpline. DePuy is committed to the wellbeing of ASR patients globally." DePuy Orthopaedics Inc is a subsidiary of Johnson & Johnson Medical equipment business and manufacturer of the ASR XL Acetabular Hip Replacement System.

As efforts to support ASR patients and their surgeons remain a priority, DePuy provided ASR website specific to India which provides detailed information regarding the recall for both patients and surgeons, including online access for surgeons to the ASR resource guide available via http://asrrecall.depuy.com/india or http://66.132.135.152/india.html

DePuy also provided an ASR resource guide containing information about the recall and reimbursement programme that was sent to all surgeons in India who implanted the ASR Hip System. The guide outlined the comprehensive patient reimbursement process and how patients should register at the ASR helpline. The company has appointed laboratory partner - Super Religare Laboratories (SRL) to enable “cashless” testing for patients. SRL is an independent healthcare services company in India, to assist patients and surgeons with tests related to the ASR hip implant. Confirmed ASR patients will not be required to pay for pre-qualified tests related to the evaluation of ASR hip implants at SRL.

DePuy has also hired third-party firms twice to help surgeons and hospitals across India to reach out to ASR patients and encourage them to register through the ASR helpline. DePuy has sent reminder letters to surgeons and hospitals about the recall and reimbursement programme, to encourage them to continue to reach out to patients. Communication was also sent to notify surgeons and hospitals on any updates including the third party outreach efforts. The last such communication was sent in June 2015.

As per Maharashtra Food and Drugs Administration Report (FDA), Over 4000 ASR hip implant surgeries were performed in India using ASR implants from May 2004 to August 2010 before the global voluntary product recall. Thousands of people across the US have received the DePuy ASR hip replacement system between 2005 and 2010, when it was finally recalled.

In August 2010, DePuy Orthopaedics Inc - UK based manufacturer issued a worldwide voluntary recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12-13 per cent) who had received the devices had to undergo revision surgery within five years of receiving it.