& # 39; His hip implant recalled in Australia, the same month Johnson & Johnson received a registration certificate in India & # 39;



Written by Kaunain Sheriff M
| New Delhi

Updated: August 25, 2018 18:23:56 pm


Johnson & Johnson, Johnson & Johnson surgery, Johnson & Johnson hip surgery, hip replacement, Johnson & Johnson hip prosthesis system, Johnson & Johnson research, Indian Express Completely broken: Vijay Vajhala, who had revision surgery. (Express Photo / Kaunain Sheriff M)

On 23 December 2009, the Indian branch of Johnson & Johnson received a new registration certificate for its ASR hip replacement implants from the national medical device supervisor. On 11 January 2010, the company applied for an import license on the basis of that certificate.

However, the company did not inform the authorities at the time the product was recalled in Australia in December 2009, a committee established by the Ministry of Health has noted.

In its report describing the timeline (see box), the Committee also mentions that in the documents submitted during its investigation into the "defective" implants, the global pharmaceutical giant "has itself admitted that the product is failing". The product was recalled worldwide on 24 August 2010.

On Friday, The Indian Express reported on the main findings of the committee that led to the conclusion that the company suppressed the main facts about the damaging aftermath of hip replacement surgery in hundreds of patients using the implanted and sold implants.

The report states that more than 3,600 patients with the implants are not traceable and that at least four deaths have been reported in those who underwent surgery using these devices. J & J imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country until they were recalled worldwide in 2010.

Read also Top official searched for CBI probe: & # 39; Failure of govt & # 39;

When contact was made with The Indian Express, a spokesperson for the company said: "We would like to clarify that DePuy Australia has taken the decision to stop selling the ASR Hip system in Australia due to the declining demand. no recall in Australia, actually the ASR hip system was voluntarily recalled by DePuy around the world in August 2010. "

The governmental committee stated in its report that it had been informed of the recall by the Australian authorities. It states that the company may have violated Indian law by later requesting a new license to sell the devices in the country.

Read also Govt panel: Johnson & Johnson buried important facts about defective operations on hip implants, held regulator in the dark & ​​# 39;

"The company had applied for an import license on the basis of the registration certificate on 11 January 2010. However, the fact that the ASR was already recalled in Australia in December 2009 did not become a license that was licensed at CDSCO at the time of the application for import. committee notes that the company seems to suppress the material facts to the CDSCO, which is considered a serious violation of an approval condition, "states the committee's report.

The Central Drugs Standard Control Organization (CDSCO) is the national regulator for medicines and medical devices. According to the CDSCO rules, when the registration certificate is issued to a medical device, it is mandatory for the manufacturer to inform the regulator of any negative reports about the product worldwide.

J & J's hip implants, manufactured by her daughter DePuy Orthopedics Inc, were first approved by the US Food and Drug Administration in 2005. Australia was one of the first countries to adopt regulatory measures to remove the ASR hip replacement system from the market.

With reference to Australia, the committee said: "The ASR hip replacement was removed from the Australian market after intervention by Therapeutic Goods Administration (TGA) in December 2009. The TGA had acted on the basis of data from the Australian National Joint Replacement Registry (NJRR). ) who had an unacceptable (high number of) revision surgery in patients who received an ASR. "

The report states that the company only informed CDSCO of the Australian findings on 8 March 2010. Five months later – on August 10, 2010 – the company gave its decision to voluntarily recall the ASR, according to the report.

The committee also makes detailed comments in its report on the failure of the product.

"… the commission noted that in an urgent Field Safety Notice (FSN) issued by the company on August 24, 2010, they themselves admitted that the product has not succeeded … the company also stated that the product metal wear dirt caused and increased release of cobalt and chromium over 7 parts per billion, "the report said.

"The committee noted that almost all revision operations were performed within 7 years on average from the date of primary surgery, while the average life span of orthopedic hip implants is 15. This indicates premature revision operations solely because of ASR," it says.

Express Editorial | Failure to follow hip replacement operations is expensive. The national joint registry must closely monitor implants

To support her conclusions, the report said, the committee sent letters to 101 patients on an "arbitrary basis," of which 22 replied. Based on the answers, the Committee found that not only the patients were reviewed after the first operation, but "in some cases more than one revision operation was performed".

"The patients suffered physical injury, physical limitation, conscious pain and suffering, high level of toxic metal, high metal ion levels in the bloodstream, loss of pleasure in life, lack of mobility, metal sensitivity, release of the prosthesis, infection, dislocation , bone fracture and a medical need and need for a surgical revision consisting of removing the implanted device from the firm and replacing an implanted device with a non-defective implant, "the report said.

The committee, chaired by Dr. Arun Agarwal, former dean and professor of ENT, Maulana Azad Medical College, New Delhi, has recommended that J & J be held liable for paying at least Rs 20 lakh to each affected patient, and that the reimbursement program for revision operations should continue until August 2025.

The committee, which was established on 8 February 2017, submitted its report on 19 February 2018. The government still has to implement the recommendations.

Johnson & Johnson replies:

& # 39; Actions related to product were appropriate, responsible & # 39;

DePuy has the highest priority and has always been patient safety. We understand that the voluntary recall of the ASR ™ hip system from August 2010 is important for patients, their relatives and surgeons. Since the voluntary recall decision was taken, DePuy has worked to provide patients and surgeons with the information and support they need, including a reimbursement program to address recall-related costs that were the first of its kind worldwide.

After years of testing, ASR was imported and marketed in India and in various countries around the world, with all the regulatory approval and permissions applicable at that time. After it was on the market, DePuy continued studying and keeping a close eye on how the device was performing and in August 2010 DePuy made a voluntary recall of the ASR hip system after receiving new information from the British national joint register.

DePuy & # 39; s actions related to the product were appropriate and responsible. We immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall. Since then, we have kept the DCGI informed of all important actions and provided the Indian patients and surgeons with the information and support they need, in accordance with government requirements.

DePuy fully cooperated with the committee of experts in their investigation into the ASR issue. However, the expert committee report has not yet been submitted to the company for assessment, so it would be inappropriate to comment on it. We would like to reiterate that we have made complete facts and data available to the expert committee.

In addition to the above statement, we also want to give you a background on some important actions taken by the company in India to maximize the reach of the patient:

ASR Help Line: In September 2010, DePuy set up an unprecedented reimbursement process and ASR Helpline for ASR patients in India through Puri Crawford. ASR website specifically for India: DePuy provided detailed information about the recall for both patients and surgeons, including online access for surgeons to the ASR source guide available at http://asrrecall.depuy.com/india Newspaper advertising: DePuy also published ads in leading newspapers about the ASR helpline and the compensation program to reach the general public. Surgery resources: DePuy provided an ASR resource guide with information about the recall and reimbursement program sent to all surgeons in India who implanted the ASR Hip System. The guide outlined the comprehensive process for patient reimbursement and how patients had to register on the ASR helpline. Seconded independent external companies to assist surgeons in outreach: DePuy hired two external firms to help surgeons and hospitals in India reach ASR patients and encouraged them to register via the ASR helpline. Strengthening communication: DePuy sent multiple reminders to surgeons and hospitals about the recall and reimbursement program to encourage them to further reach their patients. Regarding your question about Australia, we would like to clarify that DePuy Australia has taken the decision to stop selling the ASR hip system in Australia due to decreasing demand. In 2009 there was no recall in Australia. Actually, the ASR hip system was voluntarily recalled by DePuy in August 2010.

Note: ASR continues to function well for many patients in India and the rest of the world.

Start your day in the best way with the Express Morning Briefing

Download the Indian Express app for all the latest India news


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& # 39; His hip implant recalled in Australia, the same month Johnson & Johnson received a registration certificate in India & # 39;



Written by Kaunain Sheriff M
| New Delhi

Updated: August 25, 2018 18:23:56 pm


Johnson & Johnson, Johnson & Johnson surgery, Johnson & Johnson hip surgery, hip replacement, Johnson & Johnson hip prosthesis system, Johnson & Johnson research, Indian Express Completely broken: Vijay Vajhala, who had revision surgery. (Express Photo / Kaunain Sheriff M)

On 23 December 2009, the Indian branch of Johnson & Johnson received a new registration certificate for its ASR hip replacement implants from the national medical device supervisor. On 11 January 2010, the company applied for an import license on the basis of that certificate.

However, the company did not inform the authorities at the time the product was recalled in Australia in December 2009, a committee established by the Ministry of Health has noted.

In its report describing the timeline (see box), the Committee also mentions that in the documents submitted during its investigation into the "defective" implants, the global pharmaceutical giant "has itself admitted that the product is failing". The product was recalled worldwide on 24 August 2010.

On Friday, The Indian Express reported on the main findings of the committee that led to the conclusion that the company suppressed the main facts about the damaging aftermath of hip replacement surgery in hundreds of patients using the implanted and sold implants.

The report states that more than 3,600 patients with the implants are not traceable and that at least four deaths have been reported in those who underwent surgery using these devices. J & J imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country until they were recalled worldwide in 2010.

Read also Top official searched for CBI probe: & # 39; Failure of govt & # 39;

When contact was made with The Indian Express, a spokesperson for the company said: "We would like to clarify that DePuy Australia has taken the decision to stop selling the ASR Hip system in Australia due to the declining demand. no recall in Australia, actually the ASR hip system was voluntarily recalled by DePuy around the world in August 2010. "

The governmental committee stated in its report that it had been informed of the recall by the Australian authorities. It states that the company may have violated Indian law by later requesting a new license to sell the devices in the country.

Read also Govt panel: Johnson & Johnson buried important facts about defective operations on hip implants, held regulator in the dark & ​​# 39;

"The company had applied for an import license on the basis of the registration certificate on 11 January 2010. However, the fact that the ASR was already recalled in Australia in December 2009 did not become a license that was licensed at CDSCO at the time of the application for import. committee notes that the company seems to suppress the material facts to the CDSCO, which is considered a serious violation of an approval condition, "states the committee's report.

The Central Drugs Standard Control Organization (CDSCO) is the national regulator for medicines and medical devices. According to the CDSCO rules, when the registration certificate is issued to a medical device, it is mandatory for the manufacturer to inform the regulator of any negative reports about the product worldwide.

J & J's hip implants, manufactured by her daughter DePuy Orthopedics Inc, were first approved by the US Food and Drug Administration in 2005. Australia was one of the first countries to adopt regulatory measures to remove the ASR hip replacement system from the market.

With reference to Australia, the committee said: "The ASR hip replacement was removed from the Australian market after intervention by Therapeutic Goods Administration (TGA) in December 2009. The TGA had acted on the basis of data from the Australian National Joint Replacement Registry (NJRR). ) who had an unacceptable (high number of) revision surgery in patients who received an ASR. "

The report states that the company only informed CDSCO of the Australian findings on 8 March 2010. Five months later – on August 10, 2010 – the company gave its decision to voluntarily recall the ASR, according to the report.

The committee also makes detailed comments in its report on the failure of the product.

"… the commission noted that in an urgent Field Safety Notice (FSN) issued by the company on August 24, 2010, they themselves admitted that the product has not succeeded … the company also stated that the product metal wear dirt caused and increased release of cobalt and chromium over 7 parts per billion, "the report said.

"The committee noted that almost all revision operations were performed within 7 years on average from the date of primary surgery, while the average life span of orthopedic hip implants is 15. This indicates premature revision operations solely because of ASR," it says.

Express Editorial | Failure to follow hip replacement operations is expensive. The national joint registry must closely monitor implants

To support her conclusions, the report said, the committee sent letters to 101 patients on an "arbitrary basis," of which 22 replied. Based on the answers, the Committee found that not only the patients were reviewed after the first operation, but "in some cases more than one revision operation was performed".

"The patients suffered physical injury, physical limitation, conscious pain and suffering, high level of toxic metal, high metal ion levels in the bloodstream, loss of pleasure in life, lack of mobility, metal sensitivity, release of the prosthesis, infection, dislocation , bone fracture and a medical need and need for a surgical revision consisting of removing the implanted device from the firm and replacing an implanted device with a non-defective implant, "the report said.

The committee, chaired by Dr. Arun Agarwal, former dean and professor of ENT, Maulana Azad Medical College, New Delhi, has recommended that J & J be held liable for paying at least Rs 20 lakh to each affected patient, and that the reimbursement program for revision operations should continue until August 2025.

The committee, which was established on 8 February 2017, submitted its report on 19 February 2018. The government still has to implement the recommendations.

Johnson & Johnson replies:

& # 39; Actions related to product were appropriate, responsible & # 39;

DePuy has the highest priority and has always been patient safety. We understand that the voluntary recall of the ASR ™ hip system from August 2010 is important for patients, their relatives and surgeons. Since the voluntary recall decision was taken, DePuy has worked to provide patients and surgeons with the information and support they need, including a reimbursement program to address recall-related costs that were the first of its kind worldwide.

After years of testing, ASR was imported and marketed in India and in various countries around the world, with all the regulatory approval and permissions applicable at that time. After it was on the market, DePuy continued studying and keeping a close eye on how the device was performing and in August 2010 DePuy made a voluntary recall of the ASR hip system after receiving new information from the British national joint register.

DePuy & # 39; s actions related to the product were appropriate and responsible. We immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall. Since then, we have kept the DCGI informed of all important actions and provided the Indian patients and surgeons with the information and support they need, in accordance with government requirements.

DePuy fully cooperated with the committee of experts in their investigation into the ASR issue. However, the expert committee report has not yet been submitted to the company for assessment, so it would be inappropriate to comment on it. We would like to reiterate that we have made complete facts and data available to the expert committee.

In addition to the above statement, we also want to give you a background on some important actions taken by the company in India to maximize the reach of the patient:

ASR Help Line: In September 2010, DePuy set up an unprecedented reimbursement process and ASR Helpline for ASR patients in India through Puri Crawford. ASR website specifically for India: DePuy provided detailed information about the recall for both patients and surgeons, including online access for surgeons to the ASR source guide available at http://asrrecall.depuy.com/india Newspaper advertising: DePuy also published ads in leading newspapers about the ASR helpline and the compensation program to reach the general public. Surgery resources: DePuy provided an ASR resource guide with information about the recall and reimbursement program sent to all surgeons in India who implanted the ASR Hip System. The guide outlined the comprehensive process for patient reimbursement and how patients had to register on the ASR helpline. Seconded independent external companies to assist surgeons in outreach: DePuy hired two external firms to help surgeons and hospitals in India reach ASR patients and encouraged them to register via the ASR helpline. Strengthening communication: DePuy sent multiple reminders to surgeons and hospitals about the recall and reimbursement program to encourage them to further reach their patients. Regarding your question about Australia, we would like to clarify that DePuy Australia has taken the decision to stop selling the ASR hip system in Australia due to decreasing demand. In 2009 there was no recall in Australia. Actually, the ASR hip system was voluntarily recalled by DePuy in August 2010.

Note: ASR continues to function well for many patients in India and the rest of the world.

Start your day in the best way with the Express Morning Briefing

Download the Indian Express app for all the latest India news


Source link

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