The DePuy ASR case. Not everyone has been warned.
The register on the ministry's interventions has not yet started
It shouldn't have caused alarmism, but obviously something didn't work. The withdrawal from the market of DePuy ASR hip prostheses, which began a year and a half ago, is still causing alarm among patients. A report by Striscia la Notizia, aired on January 13, brought the story back to the attention of the public. So much so that even our editorial staff received requests for information from some concerned readers. So we tried to clarify the situation.
WITHDRAWAL FROM THE MARKET ¬ On 24 August 2010, DePuy, a US company of the giant Johnson & Johnson, decided to voluntarily withdraw from the market all the products of the model identified with the initials ASR: that is, the ASR resurfacing prostheses and the ASR acetabular system XL. Resurfacing prostheses and the acetabular system have been implanted in Italian patients since March 2004. As DePuy herself explains, the company has a surveillance system for its products that checks for any problems five years after surgery. In this case, the company received data from the UK National Joint Registry, which reported surgical revision rates for approximately 12% of patients who had the resurfacing system implanted. hip ASR and approximately 13% of patients with the ASR XL acetabular system. “The company therefore decided that the voluntary recall was in the best interest of patients, whose safety is and has always been a priority for DePuy,” DePuy spokespersons in Italy know.
WHAT HAPPENED TO THE PROSTHESES? - In based on a Field Safety Notice from DePuy dated August 24, 2010 sent to the Ministry of Health, which published it on its website on 31 August 2010, and at the same time as the orthopedic surgeons, Italian public, private accredited and private hospitals) there would be "detachment of the components, pockets of liquid, dislocation, awareness to metal and pain ». Worn metal debris from dentures could also end up in soft tissue and cause damage. For this reason, doctors are advised to submit patients to blood tests for the measurement of cobalt and chromium ions, which can highlight the presence of the metal and therefore the malfunction of the prosthesis itself. On November 7, 2011, the Ministry of Health has sent a recommendation to all the structures concerned, in which the attention of all healthcare professionals performing DePuy ASR and ASR XL implants is drawn to the importance of inviting patients to undergo the verification program. This is because, obviously, it has not yet been possible to reach all the people who have implanted the model withdrawn from the market.
HOW MANY PATIENTS ARE INVOLVED? - Worldwide, DePuy has sold approximately 93 ASR systems. In Italy, more than 4.500 to over 200 hospitals. “Many ASR patients have called the toll-free number set up by DePuy and participated in the reimbursement program - underline the company spokespersons-. The company is not aware of the exact number of surgical reviews, as it does not have access to this type of information.
WHAT TO DO? - Since the recall decision was made, the company has provided recommendations on actions to be taken in relation to ASR products and patient management. A first simple check concerns the dates and the prosthesis model. The recall only concerns the ASR model. The company in Italy sold the first device in March 2004, so if patients underwent surgery before 2004 they are definitely not involved in this recall. "However, we realize that various types and brands of hip prostheses are on the market and patients may not be aware of what they have been implanted - the spokesmen say -. DePuy therefore encourages patients to check with their doctor or hospital what type of prosthesis they have. If the patient has undergone surgery after March 2004, they should contact their doctor or hospital and check if the prosthesis is of the DePuy ASR model. ' In addition to this information, based on what we have been told by the officials of the Higher Institute of Health, we add that the data on the prosthesis is in the medical record. If the patient does not already have a copy in hand, he can ask for it at the hospital or private facility where he was operated on. DePuy has also prepared Guidelines for the recall and the clinical and diagnostic pathway of the patient, as well as Guidelines for obtaining reimbursement of expenses both those incurred by hospitals, including administrative expenses, and those faced by patients who will have to be subjected to checks and / or surgical treatments. «The reimbursement program for patients implanted with ASR products is well defined and DePuy has provided information and support to all doctors who are following patients with an ASR implant - add company spokespersons ¬-. A telephone line was also activated exclusively for patients implanted with the ASR XL acetabular system and the DePuy ASR hip resurfacing system: the toll-free number is 800 14 60 60 active from Monday to Friday from 8 to 17 ". Others information, but in English can be found on the site