OPENING STATEMENT. I would like to give you a brief overview of the IMB s role and remit specifically in relation to medical devices.

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "OPENING STATEMENT. I would like to give you a brief overview of the IMB s role and remit specifically in relation to medical devices."

Transcription

1 IRISH MEDICINES BOARD OIREACHTAS JOINT COMMITTEE ON HEALTH & CHILDREN DEPUY ASR (TM) ARTICULAR SURFACE REPLACEMENT AND ASR (TM) XL ACETABULAR SYSTEM 19 JULY 2012 OPENING STATEMENT INTRODUCTION Good morning Chairman and Committee members. My name is Pat O Mahony, Chief Executive of the Irish Medicines Board (IMB) and I am joined by my colleague Ms. Andrea Hanson, a Product Manager, involved in the monitoring of medical devices safety. The role of the IMB is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products. I would like to give you a brief overview of the IMB s role and remit specifically in relation to medical devices. The IMB is the Competent Authority for medical devices in Ireland. As I outlined to the Committee when I spoke to you on 29 March 2012 regarding the PIP breast implant issue, the IMB has a post market role where we monitor medical devices that are on the market and are in use in patients and health care settings. The IMB is responsible for monitoring and vigilance of these medical devices and our task is to detect, monitor, assess and act when required on safety issues that are identified. In addition, we designate and monitor the one notified body for medical devices based in Ireland. There are many thousands of products classified as medical devices comprising a diverse array including for example syringes, mobility aids, contact lenses; diagnostic tests kits such as pregnancy test kits; diagnostic equipment such as CT scanners; and the so called invasive devices such as pacemakers, cardiac stents, breast implants and indeed hip implants. Medical devices are widely used in health care and individual devices make a major contribution to the health and wellbeing of patients. Our role is to monitor the safety of these devices on the Irish market and in patient use. We ensure that any safety issue identified, be it through national incident reports or from international data, is acted upon decisively. The IMB has no direct role in approving or certifying medical devices that are marketed in Ireland or any other country. IMB opening statement Oireachtas Joint Committee on Health & Children, 19 July 2012 Page 1 of 6

2 PREMARKET APPROVAL OF MEDICAL DEVICES To place a medical device such as a hip implant on the Irish or EU market, the manufacturer must be authorised to do so following an assessment conducted by a notified body for medical devices. There are currently over eighty such notified bodies based in Europe (one in Ireland) and the manufacturer can choose any designated notified body to which it can apply for assessment and the award of a CE mark. Following its assessment and once satisfied that the device meets the relevant requirements, the notified body will issue a certificate for the medical device. This entitles the manufacturer to affix a CE mark to the device and thereafter market the product throughout Europe (annex 1). Orthopaedic implants, such as the DePuy ASR (TM) Articular Surface Replacement and ASR (TM) XL Acetabular System, are regulated under the medical devices directive 93/42/ EEC which specifies the requirements that must be met before a device can be placed on the market. These requirements cover safety, performance, specification, design, manufacture and packaging of devices and the need for a medical device to be CE marked before it can be placed on the EU market. Medical devices are graded in a system from Class I to Class III, according to risk Class III being the highest risk medical devices. Hip implants are Class III medical devices. For such Class III implants, the manufacturer must seek approval from a notified body. The review by the notified body includes an examination of the design of the product, the pre-clinical and clinical data and the manufacturing site quality system. The DePuy ASR (TM) Articular Surface Replacement and ASR (TM) XL Acetabular System were manufactured at the DePuy Orthopaedics UK facility in Leeds. The products were assessed by a notified body the British Standards Institute (BSI) in the UK prior to the initial launch on the EU market in As mentioned earlier, once a manufacturer has received the CE mark from a notified body, they are free to market their product throughout Europe without further national assessment. The products were also licensed and widely used internationally including in the US (ASR XL only), Australia and Canada. HIP REPLACEMENT SURGERY Hip replacement is most commonly used to treat joint failure or chronic pain and in general is effective in providing pain relief and improving hip function. Hip prostheses are subject to continuous research and development in order to increase their lifespan and reduce the likelihood of complications and revision surgery. This is reflected by the large variety of hip prostheses on the market, and the ongoing innovation in the field. The principles of design of hip replacement products have evolved over the past 50 years. I refer the members to the illustrations on page 3. As illustrated, the devices are modular in nature consisting of multiple components for the femoral head which is the top of the leg bone and the acetabulum which is the hip socket. In hip replacement products, the different components allow for different combinations of bearing (articulating) surfaces including ceramic-on-ceramic, metal-on-plastic, and metal-on-metal. IMB opening statement Oireachtas Joint Committee on Health & Children, 19 July 2012 Page 2 of 6

3 In traditional total hip replacements, whichh you can see in the diagram (left image), the femoral component consists of a metal stem that is placed into the centre of the femur and a metal or ceramic ball thatt is placed on the upper part of the femoral stem, replacing the damagedd bone that has been removed. The acetabulum or hip socket is replaced with a metal cup which may be lined with a plastic, ceramic or metal insert/liner between the head and socket. The alternative hip resurfacing products can be seen in the diagram (right image). The design has a different femoral component that requires replacement of only the upper surface of the head of the femur. As you can see in this surgery, less bone is removed from the femur as compared to traditional total hip replacement surgery. Resurfacing requires stronger bone, so is usually reserved for younger adults who are more active. Only a small number of hip procedures are resurfacing. We know for examplee from the UK national joint registry data in 2009 and 2010 that only 6% and 3% of hip replacement procedures were resurfacing. Every hip implant system has a unique set of benefits and risks. The Orthopaedic surgeon treating the individual patient determines which hip implant will offer the most benefit and least risk for that individual. When making this decision the surgeon will consider several factors such as age, weight, height, activity level and the cause of pain. The recommendedd surgery may involve total hip replacement or hip resurfacing. THE DEPUY HIP REPLACEMENT RECALL DePuy announced a worldwide recall of the DePuy ASR (TM) Articular Surface Replacement and ASR (TM) XL Acetabular System on 26 August 2010 (annex IV). The decision was based on new, unpublished data from the National Joint Registry (NJR) of England and Wales. The data showed the five year revision rates for the ASR Articular Surface Replacemen t was approximately 12% and for the ASR XL Acetabular System was approximately 13%. IMB opening statement Oireachtas Joint Committee on Health & Children, 19 July 2012 Page 3 of 6

4 DePuy confirmed on 27 August 2010 that the total number of ASR hip implants supplied to the Irish market was approximately 3,500. By that time the IMB had received 12 reports of revision surgeries in Ireland. In the immediate aftermath of the recall announcement DePuy confirmed to the IMB that all unused product had been removed from Irish hospitals. The IMB issued a safety notice to stakeholders including the HSE, private hospitals and the orthopaedic community in relation to this announcement (annex II). An IMB press release was circulated and published on our website (annex III). The IMB worked with the HSE and Irish orthopaedic surgeons regarding the recommendations for patient follow-up. We understand that the HSE and private hospitals continue to manage the review and follow-up of patients who have received ASR hip implants. Further to the 12 revision surgeries that had been reported to the IMB at the time of the recall, we are now aware of an additional 357 patients who have undergone revision surgery with a further 166 revisions scheduled (June 2012 figures as supplied by HSE). PRE-RECALL ACTIVITY By way of background, in line with our post market surveillance remit, the IMB had been monitoring the performance of the ASR hip systems since their introduction to the market. We also had ongoing discussions with the manufacturer and our European and international medical device colleagues. There was regular communication with the Medicines and Healthcare products Regulatory Agency (MRHA) in the UK in particular as it was the lead Competent Authority in Europe on this product. Both the manufacturer and the notified body were located in the UK. The higher than expected revision rates associated with the ASR Hip System highlighted in the DePuy Field Safety Notice issued in March 2010 was a particular focus of discussion. This revision rate data concurred with observations emerging from market surveillance from the national joint registries in UK, Sweden and Australia. At this point it is worth noting that there is at present no national joint registry in Ireland. The IMB ensured that the March 2010 Field Safety Notice was circulated by DePuy to orthopaedic surgeons who used the device in Ireland (annex IV). This notice provided recommendations to the orthopaedic surgeons in relation to surgical technique and patient selection in order to achieve optimal implant performance. In the communication, users were reminded of several key factors including optimal implant positioning (in particular insertion angle) and patient selection and consideration of their bone quality. The importance of appropriate post operative care was also highlighted. There is a copy of this Field Safety Notice in the documentation provided. POST-RECALL ACTIVITY The IMB has remained in close contact with DePuy, the HSE and Irish Orthopaedic surgeons in monitoring the implementation of the recommended patient follow up. The IMB continues to assess the reported incidents that it receives relating to revision procedures. The IMB is monitoring the investigation that continues to be conducted by DePuy. The matter is also under regular on-going consideration at European medical devices experts meetings. IMB opening statement Oireachtas Joint Committee on Health & Children, 19 July 2012 Page 4 of 6

5 DePuy continues to investigate the matter through the analysis of data generated from complaints received, from the Joint Registry data, from its clinical studies and from re-examination of the failure analysis data. Also, independent analysis of explanted devices continues with the aim of identifying the causes of the higher than expected revision rates. This analysis is being conducted at the London Implant Retrieval Centre (LIRC) where returned explanted devices are inspected. To date the root cause of the problem has not yet been clearly identified. Many complex factors can influence a successful outcome for a hip replacement surgery including: a patient s clinical condition and general health, the component or device selection, implantation technique and the post operative recovery and rehabilitation regime. The data from this ASR recall has provided important input to the wider discussions regarding metal on metal (MoM) implants on an international basis. There is emerging evidence of increased revision rates associated with large head metal on metal hip replacements but the clinical evidence available to date is mixed and therefore does not support their removal from the market. Device wear is experienced with all types of hip replacement implants over time as the femoral head and acetabular cup components articulate. With a MoM hip system, this can lead to the production and accumulation of metal ions (e.g., cobalt and chromium) within the area around the implant. The size of the released wear debris is in the range of nanometres. Most patients with conventional MoM prostheses exhibit higher chromium and cobalt ion concentrations in blood, which are however, only very rarely related with pathologies. Individuals react differently to the metal ions. Many patients have no significant reaction to these materials while for some others there may be an inflammatory response which, in time, can lead to local bone and tissue reaction. The effects of long term low-level exposure to such metal ions are under detailed on-going review by scientists and regulators worldwide. The IMB continues to work with our European and international colleagues to better understand the complexities of the performance of these medical devices. In this regard, we welcome the recent news that a national register for orthopaedic surgery is being established under the Governance of the recently established National Office of Clinical Audit. The Irish National Orthopaedic Register has been identified for delivery in This will allow for more comprehensive Irish specific data in the future, which data will be added to that available elsewhere and will allow for timely comparison of trends emerging in Ireland with the experiences elsewhere on an implant by implant basis. The IMB will continue to take appropriate regulatory action as required. THE REVISION OF THE MEDICAL DEVICES LEGISLATION The three primary European Directives relating to medical devices are being substantially revised by the European Commission and it is expected that they will adopt two new Regulations relating to medical devices in September These will then be subject to debate at the European Council and Parliament (annex VI). IMB opening statement Oireachtas Joint Committee on Health & Children, 19 July 2012 Page 5 of 6

6 In early February 2012, Commissioner Dalli (Health & Consumers) wrote to each of the national Ministers for Health across Europe indicating the need to increase control on medical devices to provide an appropriate level of protection to European citizens and to restore trust and confidence in the regulatory system for devices. Commissioner Dalli recognised that legislative revision would take several years to come into effect and identified the need to act immediately to achieve these objectives (annex V). CLOSING REMARKS The IMB, in recognising the great benefits that hip replacement medical devices and surgery provides to many patients, fully appreciates the difficulties this issue has caused for individual patients who are directly affected and for their families. We will continue to provide updates to patients and the orthopaedic community as new data emerges. It is imperative that the issues involved are fully researched and understood. The IMB contribution to this international effort continues and the new European medical devices regulations and the establishment of the Irish register will assist in this effort not only as related to hip replacement devices, but for all medical devices used in patients. Thank you Chairman and we would be pleased to take any questions. IMB opening statement Oireachtas Joint Committee on Health & Children, 19 July 2012 Page 6 of 6

ANNEXES. Medical device approval process. Annex II IMB safety notice, 27 August 2010. Annex III IMB ASR press statement.

ANNEXES. Medical device approval process. Annex II IMB safety notice, 27 August 2010. Annex III IMB ASR press statement. IRISH MEDICINES BOARD OIREACHTAS JOINT COMMITTEE ON HEALTH & CHILDREN DEPUY ASR (TM) ARTICULAR SURFACE REPLACEMENT AND ASR (TM) XL ACETABULAR SYSTEM 19 JULY 2012 ANNEXES Annex I Medical device approval

More information

Answers to commonly asked questions from patients with metal-on-metal hip replacements / resurfacings. Contents

Answers to commonly asked questions from patients with metal-on-metal hip replacements / resurfacings. Contents Answers to commonly asked questions from patients with metal-on-metal hip replacements / resurfacings John Skinner 1 and Alister Hart 2, Consultant Orthopaedic Surgeons and Directors of the London Implant

More information

Metal-on-metal hip replacement implants

Metal-on-metal hip replacement implants Metal-on-metal hip replacement implants Information for general practitioners, orthopaedic surgeons and other health professionals 20 September 2012 Key points Metal-on-metal (MoM) hip implants (in which

More information

Information for Our Patients Regarding Metal-on-Metal (MoM) Hip Replacements

Information for Our Patients Regarding Metal-on-Metal (MoM) Hip Replacements Information for Our Patients Regarding Metal-on-Metal (MoM) Hip Replacements The American Association of Hip and Knee Surgeons, The Hip Society and the American Academy of Orthopaedic Surgeons Concerns

More information

We have carefully reviewed your questions and the recent promotion for your program on the ABC website.

We have carefully reviewed your questions and the recent promotion for your program on the ABC website. 23 May 2014 Mr P Cronau Senior Producer, Four Corners, The ABC, GPO Box 9994, Sydney NSW 2001. Dear Mr Cronau, We have carefully reviewed your questions and the recent promotion for your program on the

More information

Medical Device Alert. Device All metal-on-metal (MoM) hip replacements. Action by. CAS deadlines. Ref: MDA/2012/036 Issued: 25 June 2012 at 11:00

Medical Device Alert. Device All metal-on-metal (MoM) hip replacements. Action by. CAS deadlines. Ref: MDA/2012/036 Issued: 25 June 2012 at 11:00 Medical Device Alert Issued: 25 June 2012 at 11:00 Device All metal-on-metal (MoM) hip replacements Problem The MHRA is issuing updated information and advice about the follow-up of implanted with metal-on-metal

More information

making informed choices high performance hip replacement

making informed choices high performance hip replacement high performance hip replacement Is Hip Replacement Surgery Right For You? If you have gradually stopped doing the things you enjoy or are adapting your life to cope with reduced mobility, hip replacement

More information

Randal S. Ford. ATTORNEY AT LAW (205) 752-4440 attorney@randalsford.com. DePuy ASR Hip Implant Recall Fact Sheet

Randal S. Ford. ATTORNEY AT LAW (205) 752-4440 attorney@randalsford.com. DePuy ASR Hip Implant Recall Fact Sheet DePuy ASR Hip Implant Recall Fact Sheet Recalled Devices: ASR XL Acetabular System on the market since 2004, and sold worldwide. Dates of Implant: July 2003 to 2010 ASR Hip Resurfacing System on the market

More information

Appendix B: FDA Safety Communication (Website) for MoM Hip Systems

Appendix B: FDA Safety Communication (Website) for MoM Hip Systems Appendix B: FDA Safety Communication (Website) for MoM Hip Systems. 1 Metal on Metal Hip Implant Systems Home Page The Hip Joint Hip Implant Systems Metal-on-Metal Hip Implant Systems Total Hip Replacement

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Total hip replacement and resurfacing arthroplasty for the treatment of pain or disability resulting from end stage arthritis

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Total hip replacement and resurfacing arthroplasty for the treatment of pain or disability resulting from end stage arthritis

More information

DePuy Orthopaedics ASR Recall Reference Guide for U.S. Healthcare Professionals

DePuy Orthopaedics ASR Recall Reference Guide for U.S. Healthcare Professionals DePuy Orthopaedics ASR Recall Reference Guide for U.S. Healthcare Professionals DPYUS 46 (Version 2) 1 October 18, 2010 Contents 1. Available Resources... 3 Surgeon-to-Patient Communications Support...

More information

Hip replacements: Getting it right first time

Hip replacements: Getting it right first time Report by the Comptroller and Auditor General NHS Executive Hip replacements: Getting it right first time Ordered by the House of Commons to be printed 17 April 2000 LONDON: The Stationery Office 0.00

More information

Total Hip Joint Replacement. A Patient s Guide

Total Hip Joint Replacement. A Patient s Guide Total Hip Joint Replacement A Patient s Guide Don t Let Hip Pain Slow You Down What is a Hip Joint? Your joints are involved in almost every activity you do. Simple movements such as walking, bending,

More information

Metal-on-metal hip implants

Metal-on-metal hip implants Metal-on-metal hip implants The performance of the medical device quality assurance chain needs to be improved Utrecht, May 2013 Metal-on-metal hip implants May 2013 Contents Summary 5 1 Introduction

More information

Choice of Bearing Surface for Total Hip Replacement Affects Need for Repeat Surgery: A Canadian Perspective

Choice of Bearing Surface for Total Hip Replacement Affects Need for Repeat Surgery: A Canadian Perspective Choice of Bearing Surface for Total Hip Replacement Affects Need for Repeat Surgery: A Canadian Perspective Nicole de Guia, Manager, Joint Replacement & MS Registries CAHSPR Conference 2014, Toronto, Ontario

More information

RECALLS in EUROPE. Past, present, near & further future. Gert Bos BSI Medcon May 2012

RECALLS in EUROPE. Past, present, near & further future. Gert Bos BSI Medcon May 2012 RECALLS in EUROPE Past, present, near & further future Gert Bos BSI Medcon May 2012 A C P D Vigilance, vigilant: Continually watchful or on guard; always prepared for possible danger Content 2 Current

More information

TOTAL HIP REPLACEMENT FOR A LIFETIME: THE CEMENTLESS METAL ON METAL RECONSTRUCTION

TOTAL HIP REPLACEMENT FOR A LIFETIME: THE CEMENTLESS METAL ON METAL RECONSTRUCTION Richard A. Sweet, M.D. Louisville Orthopaedic Clinic Louisville, KY TOTAL HIP REPLACEMENT FOR A LIFETIME: THE CEMENTLESS METAL ON METAL RECONSTRUCTION INTRODUCTION Total hip replacement surgery (THR) has

More information

Y O U R S U R G E O N S. choice of. implants F O R Y O U R S U R G E R Y

Y O U R S U R G E O N S. choice of. implants F O R Y O U R S U R G E R Y Y O U R S U R G E O N S choice of implants F O R Y O U R S U R G E R Y Y O U R S U R G E O N S choice of implants F O R Y O U R S U R G E R Y Your Surgeon Has Chosen the C 2 a-taper Acetabular System The

More information

P REPLACEMENT SURGERY

P REPLACEMENT SURGERY P REPLACEMENT SURGERY DIRECT ANTERIOR APPROACH M I N I M I Z I N G R E C O V E R Y. M A X I M I Z I N G R E S U L T S. CENTER FOR MINIMAL INVASIVE JOINT SURGERY 2301 25TH STREET SOUTH FARGO ND 58103 701-241-9300

More information

Total Hip Replacement Hip replacement surgery, or arthroplasty, uses implants to resurface and replace the bones in the joint, re-creating the smooth gliding surfaces that were once intact. Hip replacement

More information

Clinical Testing for Metal-on-Metal Prosthetic Wear and Tear

Clinical Testing for Metal-on-Metal Prosthetic Wear and Tear Clinical Testing for Metal-on-Metal Prosthetic Wear and Tear Frederick G. Strathmann, PhD, DABCC (CC, TC) February 8 th, 2013 Disclosures None Objectives Compare heavy metal analysis in synovial fluid

More information

Hip, knee, ankle, elbow and shoulder anatomy and joint replacement procedures

Hip, knee, ankle, elbow and shoulder anatomy and joint replacement procedures Hip, knee, ankle, elbow and shoulder anatomy and joint replacement procedures Quick links, go to: Hips > Knees > Ankles > Elbows > Shoulders > Version 2 December 2013 1 HIPS Hip anatomy There are two main

More information

Metal-on-Metal Hip Systems

Metal-on-Metal Hip Systems Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems Center for Devices and Radiological Health U.S. Food and Drug Administration Meeting of

More information

Why an Exactech Hip is Right for You

Why an Exactech Hip is Right for You Why an Exactech Hip is Right for You Why do I need a total hip replacement? Which surgical approach is best for me? How long will it last? Which implant is right for me? Founded in 1985 by an orthopaedic

More information

References: 0086 Tel: +44 (113) Fax: +44 (113) Issued: 04/05. Cat No: Version 1

References: 0086 Tel: +44 (113) Fax: +44 (113) Issued: 04/05. Cat No: Version 1 References: 1. Data on File, DePuy International Ltd, 2003. 2. Report on the Second International Conference on Metal-metal Hip Prostheses: Past Performance and Future Directions. Montreal, 21-22 June,

More information

Patient Labeling Information System Description

Patient Labeling Information System Description Patient Labeling Information System Description The Trident Ceramic Acetabular System is an artificial hip replacement device that features a new, state-of-the-art ceramic-on-ceramic bearing couple. The

More information

Total Hip Replacement

Total Hip Replacement Total Hip Replacement Frequently Asked Questions What Is Arthritis? The bone ends in a joint are covered with a smooth glistening material called cartilage. This material cushions the underlying bone from

More information

Anterior Hip Replacement

Anterior Hip Replacement Disclaimer This movie is an educational resource only and should not be used to manage Orthopaedic health. All decisions about the management of hip replacement and arthritis management must be made in

More information

Are You Living with. Hip Pain? MAKOplasty may be the right treatment option for you.

Are You Living with. Hip Pain? MAKOplasty may be the right treatment option for you. Are You Living with Hip Pain? MAKOplasty may be the right treatment option for you. Hip pain shouldn t keep you from doing the things you love. Understanding Common Causes of Hip Pain If you are one of

More information

Want to know more about the Notified Body?

Want to know more about the Notified Body? NBG/V 2/07/14 BSI Notified Body (0086) Kitemark Court Davy Avenue Knowlhill Milton Keynes MK5 8PP United Kingdom T: +44 845 080 9000 E: eu.medicaldevices@bsigroup.com W: medicaldevices.bsigroup.com Want

More information

.URGENT DEVICE CORRECTION

.URGENT DEVICE CORRECTION zimmer.urgent DEVICE CORRECTION Zimmer, Inc. P.O. Box 706 Warsaw, IN 46561-0706 574.267.6131 www.zimmer.com July 22, 2008 Dear Surgeon: Since we last wrote to you in May 2008 regarding the Durom Acetabular

More information

A Magazine Dedicated to Mass Torts Law. The Dangers of Metal-on-Metal Hips. Details of DePuy ASR Settlement Announced. www.langdonemison.

A Magazine Dedicated to Mass Torts Law. The Dangers of Metal-on-Metal Hips. Details of DePuy ASR Settlement Announced. www.langdonemison. d3 Dangerous Drugs and Devices A Magazine Dedicated to Mass Torts Law The Dangers of Metal-on-Metal Hips Details of DePuy ASR Settlement Announced www.langdonemison.com Johnson & Johnson Agrees to Pay

More information

YOUR GUIDE TO TOTAL HIP REPLACEMENT

YOUR GUIDE TO TOTAL HIP REPLACEMENT A Partnership for Better Healthcare A Partnership for Better Healthcare YOUR GUIDE TO TOTAL HIP REPLACEMENT PEI Limited M50 Business Park Ballymount Road Upper Ballymount Dublin 12 Tel: 01-419 6900 Fax:

More information

Cormet Hip Resurfacing System

Cormet Hip Resurfacing System Cormet Hip Resurfacing System Patient Product Information 325 Corporate Drive Mahwah, NJ 07430 t: 1-888-STRYKER www.aboutstryker.com The information presented in this brochure is for educational purposes

More information

Total Hip Replacement

Total Hip Replacement Please contactmethroughthegoldcoasthospitaswityouhaveanyproblemsafteryoursurgery. Dr. Benjamin Hewitt Orthopaedic Surgeon Total Hip Replacement The hip joint is a ball and socket joint that connects the

More information

BRIEFING PAPER ON ACTIONS BEING UNDERTAKEN ASSOCIATED WITH AN MRHA ALERT NOTICE ON METAL ON METAL HIP PROSTHESES

BRIEFING PAPER ON ACTIONS BEING UNDERTAKEN ASSOCIATED WITH AN MRHA ALERT NOTICE ON METAL ON METAL HIP PROSTHESES AGENDA ITEM 2.7 21 December BRIEFING PAPER ON ACTIONS BEING UNDERTAKEN ASSOCIATED WITH AN MRHA ALERT NOTICE ON METAL ON METAL HIP PROSTHESES Report of Paper prepared by Medical Director Divisional Manager,

More information

MHRA: Metal hip implant patients need lifelong

MHRA: Metal hip implant patients need lifelong Page 1 of 5 HEALTH 28 February 2012 Last updated at 11:49 ET MHRA: Metal hip implant patients need lifelong checks The government's health regulator has advised that patients who have undergone large head

More information

Hip Resurfacing 2011 ORIGINAL ARTICLE. James W. Pritchett MD. Introduction. Abstract

Hip Resurfacing 2011 ORIGINAL ARTICLE. James W. Pritchett MD. Introduction. Abstract 1 ORIGINAL ARTICLE Hip Resurfacing 2011 James W. Pritchett MD Abstract In 1938 Marion Smith-Peterson placed a cobalt chromium cup on a reshaped femoral head to perform the first hip resurfacing. 15 Also,

More information

Changes to Medical Device Regulations

Changes to Medical Device Regulations Changes to Medical Device Regulations How these will affect distributors? IMSTA Breakfast Briefing, 24 October 2013 Niall MacAleenan Medical Device Lead, IMB. Slide 1 Content Revision of the medical device

More information

In this brochure you will: Keep in mind:

In this brochure you will: Keep in mind: Hip Implant Options Bearing Basics Today s hip implant patients are fortunate. Doctors can now choose from advanced implant materials. One choice doctors make when selecting the implant for you is called

More information

TOTAL HIP REPLACEMENT

TOTAL HIP REPLACEMENT TOTAL HIP REPLACEMENT 2 Causes of Hip Pain Arthritis is the leading cause of disability in the United States, and the most frequent cause of discomfort and chronic hip pain. In fact, it s estimated that

More information

Chapter 3. High revision rates: the consumer experience

Chapter 3. High revision rates: the consumer experience Introduction Chapter 3 High revision rates: the consumer experience 3.1 The previous chapter focussed on the role of the TGA in regulating the quality of medical devices in Australia. This examined both

More information

How medical devices are approved in Canada

How medical devices are approved in Canada How medical devices are approved in Canada In Canada, the system of approval for medical devices is governed by the Medical Device Regulations of the Department of Justice (http://laws.justice.gc.ca/eng/sor-98-282/20091229/).

More information

Your Practice Online

Your Practice Online P R E S E N T S Your Practice Online Disclaimer This information is an educational resource only and should not be used to make a decision on Revision Hip Replacement or arthritis management. All decisions

More information

The M2a-Taper metal-on-metal hip replacement People facing joint replacement of the hip often wonder if they will be able to resume a more active life

The M2a-Taper metal-on-metal hip replacement People facing joint replacement of the hip often wonder if they will be able to resume a more active life The M2a-Taper metal-on-metal hip replacement People facing joint replacement of the hip often wonder if they will be able to resume a more active lifestyle after surgery. An additional concern is whether

More information

BIRMINGHAM HIP Resurfacing (BHR ) System PATIENT INFORMATION

BIRMINGHAM HIP Resurfacing (BHR ) System PATIENT INFORMATION BIRMINGHAM HIP Resurfacing (BHR ) System PATIENT INFORMATION Table of Contents 1.0 What is the BHR Device? 2.0 What is the Purpose of the BHR Device? 3.0 When Should the BHR Device Not Be Used? (Contraindications)

More information

THE POST-MARKET PRIORITY Understanding and Meeting Demand for Effective Post-Market Clinical Follow-Up

THE POST-MARKET PRIORITY Understanding and Meeting Demand for Effective Post-Market Clinical Follow-Up Healthcare THE POST-MARKET PRIORITY Understanding and Meeting Demand for Effective Post-Market Clinical Follow-Up Introduction In his recent paper, Basic Anatomy of a Design Dossier, Dr. Hamish Forster,

More information

Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day

Medical Devices. Notified Bodies and the CE certification Process for Medical Devices. European Surgical Robotics Demonstration Day Medical Devices Notified Bodies and the CE certification Process for Medical Devices European Surgical Robotics Demonstration Day 27 th March 2014, Leuven, Belgium 1 Bart Mersseman Product Manager Medical

More information

GUIDELINES ON MEDICAL DEVICES

GUIDELINES ON MEDICAL DEVICES EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Health technology and Cosmetics MEDDEV 2.12/2 rev2 January 2012 GUIDELINES ON MEDICAL DEVICES POST MARKET CLINICAL FOLLOW-UP

More information

Hip Resurfacing (Re-Review)

Hip Resurfacing (Re-Review) 20, 2012 Health Technology Assessment Hip Resurfacing (Re-Review) Final Evidence Report October 14, 2013 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia,

More information

it s time for rubber to meet the road

it s time for rubber to meet the road your total knee replacement surgery Steps to returning to a Lifestyle You Deserve it s time for rubber to meet the road AGAIN The knee is the largest joint in the body. The knee is made up of the lower

More information

Metal on Metal Hips. Total Hip Replacement. Total Hip Replacement

Metal on Metal Hips. Total Hip Replacement. Total Hip Replacement Metal on metal hips: Questions Metal on Metal Hips Jim Sullivan Why were metal on metal hips popular? Are all metal on metal hips the same? What are the problems with the ASR hip? What are the issues with

More information

Freedom of Information Act 2000 (FOIA) Decision notice

Freedom of Information Act 2000 (FOIA) Decision notice Freedom of Information Act 2000 (FOIA) Decision notice Date: 5 March 2015 Public Authority: Address: NHS England 8E02 Quarry House Quarry Hill Leeds LS2 7UE Decision (including any steps ordered) 1. The

More information

on-metal Hips: Device Mechanics and Failure Modes

on-metal Hips: Device Mechanics and Failure Modes 1 Metal-on on-metal Hips: Device Mechanics and Failure Modes Steven M. Kurtz, Ph.D., and Richard Underwood, Ph.D. Exponent, Inc., and Drexel University NIH R01 AR47904 2 Contracts: DePuy Orthopaedics,

More information

J&J Said to Offer Implant Pact That May Reach $2 Billion

J&J Said to Offer Implant Pact That May Reach $2 Billion J&J Said to Offer Implant Pact That May Reach $2 Billion By Jef Feeley and David Voreacos - Jan 19, 2013 Johnson & Johnson (JNJ), which is fighting more than 10,000 lawsuits over its recalled hip implants,

More information

By BARRY MEIER. implant, maker of. warnings. like an patients. if a device,

By BARRY MEIER. implant, maker of. warnings. like an patients. if a device, The Implants Loophole By BARRY MEIER Published: December 16, 20100 A recently recalled artificial hip made by a unit of Johnson & Johnson, designed to last 15 years or more, is failing worldwide at unusually

More information

Technology appraisal guidance Published: 26 February 2014 nice.org.uk/guidance/ta304

Technology appraisal guidance Published: 26 February 2014 nice.org.uk/guidance/ta304 Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip Technology appraisal guidance Published: 26 February 2014 nice.org.uk/guidance/ta304 NICE 2014. All rights reserved.

More information

Anterior Approach. to Hip Replacement Surgery

Anterior Approach. to Hip Replacement Surgery Anterior Approach to Hip Replacement Surgery Introduction When debilitating pain and stiffness in your hip limits your daily activities, you may need a total hip replacement. The development of total hip

More information

ADVISING THE PROFESSIONALS: THE ROLE OF MHRA

ADVISING THE PROFESSIONALS: THE ROLE OF MHRA Safeguarding public health ADVISING THE PROFESSIONALS: THE ROLE OF DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory Agency, UK Name Date WHAT IS? Medicines and Healthcare

More information

Metal On Metal Hip Replacement and Hip Resurfacing Arthroplasty : What does the MHRA Medical Device Alert mean?

Metal On Metal Hip Replacement and Hip Resurfacing Arthroplasty : What does the MHRA Medical Device Alert mean? Metal On Metal Hip Replacement and Hip Resurfacing Arthroplasty : What does the MHRA Medical Device Alert mean? You will be aware that the MHRA (Medical and Healthcare Related Devices Agency) has been

More information

Legal Implications of Defective Hip Implants. Carolien van Weering and Antoinette Collignon 1. Introduction

Legal Implications of Defective Hip Implants. Carolien van Weering and Antoinette Collignon 1. Introduction Legal Implications of Defective Hip Implants Carolien van Weering and Antoinette Collignon 1 Introduction Over the past years the media have reported repeatedly on defective prostheses such as DePuy replacement

More information

Safeguarding public health The Regulation of Software as a Medical Device

Safeguarding public health The Regulation of Software as a Medical Device Safeguarding public health The Regulation of Software as a Medical Device Dr Head of New and Emerging Technologies Medicines and Healthcare Products Regulatory Agency (MHRA) Crown Copyright 2013 About

More information

IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA

IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA GENERAL DIVISION No: NSD213/2011 NOTICE OF FILING This document was filed electronically in the FEDERAL COURT

More information

ANTERIOR APPROACH TO HIP REPLACEMENT SURGERY

ANTERIOR APPROACH TO HIP REPLACEMENT SURGERY ANTERIOR APPROACH TO HIP REPLACEMENT SURGERY 2 Take action against your hip pain If you have experienced hip pain, chances are you have probably told yourself it is just part of getting older. If other

More information

Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC

Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC Guidance on the In Vitro Diagnostic Medical Devices Directive 98/79/EC August 2013 Contents 1 Introduction...3 2 Scope of the directive...3 2.1 What is an in vitro diagnostic medical device?... 3 2.2 Specimen

More information

The Right Choice. Exeter. total hip system

The Right Choice. Exeter. total hip system The Right Choice Exeter total hip system Exeter The Right Choice Anatomic Reconstruction Offset The objectives of total hip replacement are to: relieve pain increase mobility and function Achieving a correct

More information

PRESENTATIONS/PAPERS INTERNATIONAL. RAISING STANDARDS IN JOINT ARTHROPLASTY Course Co-Chairman, The Great Debate - London, June 2013

PRESENTATIONS/PAPERS INTERNATIONAL. RAISING STANDARDS IN JOINT ARTHROPLASTY Course Co-Chairman, The Great Debate - London, June 2013 PRESENTATIONS/PAPERS INTERNATIONAL 1998 2013 RAISING STANDARDS IN JOINT ARTHROPLASTY Course Co-Chairman, The Great Debate - London, June 2013 HOW TO CHOOSE THE RIGHT STEM FOR THE RIGHT PATIENT Corin Symposium

More information

IMPORTANT PRODUCT RECALL UPDATE RA2012-067 EXT_2

IMPORTANT PRODUCT RECALL UPDATE RA2012-067 EXT_2 325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000 Orthopaedics IMPORTANT PRODUCT RECALL UPDATE RA2012-067 EXT_2 Reference: RA 2012-067_EXT_2 (update of the action reference RA2012-067_EXT_1 dated on

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Overview Total hip replacement and resurfacing arthroplasty for treating pain or disability resulting from end stage arthritis of the hip (review of technology

More information

Map 48: Rate of metal-on-metal hip resurfacing procedures undertaken per population by PCT

Map 48: Rate of metal-on-metal hip resurfacing procedures undertaken per population by PCT 162 NHS ATLAS OF VARIATION PROBLEMS OF THE MUSCULO-SKELETAL SYSTEM Map 48: Rate of metal-on-metal hip resurfacing procedures undertaken per population by PCT Directly standardised rate 2009/10 Domain 2:

More information

Hip replacements: Getting it right first time

Hip replacements: Getting it right first time Report by the Comptroller and Auditor General NHS Executive Hip replacements: Getting it right first time HC 417 Session 1999-00 19 April 2000 Report by the Comptroller and Auditor General NHS Executive

More information

Estimating edge-loading risk in patients with metal-onmetal hip resurfacing

Estimating edge-loading risk in patients with metal-onmetal hip resurfacing Estimating edge-loading risk in patients with metal-onmetal hip resurfacing S. J. Mellon 1, G. Grammatopoulos 1, M. Andersen 2, H. Pandit 1, E. C. Pegg 1, H.S. Gill 1,3, D. W. Murray 1 1. NDORMS, University

More information

Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules?

Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? CEMO Congress, Paris, February 3rd, 2011 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs Agenda

More information

DHCPL_RA2014-170-EXT Page 1 of 6

DHCPL_RA2014-170-EXT Page 1 of 6 September 11th 2015 URGENT: Field Safety Notice RA2014-170(EXT) FSCA identifier: Type of Action: Description: Product Field Action RA2014-170(EXT) Field Safety Corrective Action: Return to supplier. LFIT

More information

Design Rationale and Surgical Technique

Design Rationale and Surgical Technique Design Rationale and Surgical Technique Maximizing performance from every angle Saving time in the operating room is one of the most valuable solutions Smith & Nephew can provide surgeons. The TANDEM BIPOLAR

More information

Wear-contact analysis of hip implant coated with functionally graded material

Wear-contact analysis of hip implant coated with functionally graded material 2014; 1(7): 439-443 IJMRD 2014; 1(7): 439-443 www.allsubjectjournal.com Received: 13-12-2014 Accepted: 30-12-2014 e-issn: 2349-4182 p-issn: 2349-5979 Impact Factor: 3.762 Vinod Pallapu M. Tech Student

More information

Total Knee Arthroplasty

Total Knee Arthroplasty Total Knee Arthroplasty Disclaimer: This background information is not intended to be a comprehensive scientific discussion of the topic, but rather an attempt to provide a baseline level of information

More information

IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA

IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA GENERAL DIVISION No: NSD213/2011 NOTICE OF FILING This document was filed electronically in the FEDERAL COURT

More information

Defective Metal on Metal Hip Implant Claims in Federal Multidistrict Litigation: More Than 8,500 Filed Cases By Hadley L.

Defective Metal on Metal Hip Implant Claims in Federal Multidistrict Litigation: More Than 8,500 Filed Cases By Hadley L. Defective Metal on Metal Hip Implant Claims in Federal Multidistrict Litigation: More Than 8,500 Filed Cases By Hadley L. Matarazzo The first artificial hips with metal on metal articulation were introduced

More information

Do your clients actually need you to advise them on health insurance, or could they simply buy online as most of us now do with say motor insurance?

Do your clients actually need you to advise them on health insurance, or could they simply buy online as most of us now do with say motor insurance? Welcome to Simplyhealth s monthly news bulletin. Each month Andy Couchman, a recognised industry expert and publisher of the Protection Review, gives an update on what is going on in the world of health

More information

VERILAST Technology for Hip Replacement Implants

VERILAST Technology for Hip Replacement Implants VERILAST Technology for Hip Replacement Implants Surgeon Name Clinic Name Clinic Address Clinic i Address Phone Number Web Address Total Hip Replacement What Is VERILAST Hip Technology? OXINIUM Oxidized

More information

CPD. Rationalising the Follow up of Patients with Metal on Metal Hip Replacements

CPD. Rationalising the Follow up of Patients with Metal on Metal Hip Replacements Rationalising the Follow up of Patients with Metal on Metal Hip Replacements Meeting Venue The Royal College of Surgeons 35-43 Lincoln s Inn Field London, WC2A 3PE Friday 26th September 2014 REGISTER BEFORE

More information

Regulation of Medical Devices in Australia and New Zealand. By Judy Bingham, MHSc, FSHP, GAICD and Philippe Robertson

Regulation of Medical Devices in Australia and New Zealand. By Judy Bingham, MHSc, FSHP, GAICD and Philippe Robertson Regulation of Medical s in Australia and New Zealand By Judy Bingham, MHSc, FSHP, GAICD and Philippe Robertson 24 Introduction The Therapeutic Goods Administration (TGA) regulates the supply of medical

More information

Defining joint replacement medical devices (hip joint; knee joint and shoulder joint) and ancillary medical devices. Version 1.

Defining joint replacement medical devices (hip joint; knee joint and shoulder joint) and ancillary medical devices. Version 1. Defining joint replacement medical devices (hip joint; knee joint and shoulder joint) and ancillary medical devices Version 1.0, April 2015 About the Therapeutic Goods Administration (TGA) The Therapeutic

More information

National Joint Registry for England and Wales 4th Annual Report

National Joint Registry for England and Wales 4th Annual Report National Joint Registry www.njrcentre.org.uk ISSN 1753-9382 National Joint Registry for England and Wales 4th Annual Report Prepared by The NJR Centre, Hemel Hempstead Peter Drury Julia Morrison Claire

More information

To: All interested organisations 25 June 2014 CONSULTATION ON THE REVOCATION OF THE CLINICAL THERMOMETERS (EEC REQUIREMENTS) REGULATIONS 1993

To: All interested organisations 25 June 2014 CONSULTATION ON THE REVOCATION OF THE CLINICAL THERMOMETERS (EEC REQUIREMENTS) REGULATIONS 1993 To: All interested organisations 25 June 2014 Our reference: DLC 1 CONSULTATION ON THE REVOCATION OF THE CLINICAL THERMOMETERS (EEC REQUIREMENTS) REGULATIONS 1993 Introduction 1. We are writing to consult

More information

Metal on Metal Hip Implant Registry

Metal on Metal Hip Implant Registry Data Collection Metal on Metal Hip Implant Registry Email questions related to data entry to Principal Investigator Jeffrey Brent, M.D., Ph.D. Prosthesis Information Enter prosthesis information Prosthesis

More information

Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices. Response from Cancer Research UK to the Commission August 2010

Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices. Response from Cancer Research UK to the Commission August 2010 Revision of the Directive 98/79/EC on In Vitro Diagnostic Medical Devices Response from Cancer Research UK to the Commission August 2010 1. Cancer Research UK (CR-UK) 1 is leading the world in finding

More information

Femoroacetabular impingement (FAI)

Femoroacetabular impingement (FAI) Femoroacetabular impingement (FAI) - Patient information Femoroacetabular impingement (FAI) What is femoroacetabular impingement? Femoroacetabular impingement (FAI) is a condition in which there is abnormal

More information

Minimally Invasive Hip Replacement through the Direct Lateral Approach

Minimally Invasive Hip Replacement through the Direct Lateral Approach Surgical Technique INNOVATIONS IN MINIMALLY INVASIVE JOINT SURGERY Minimally Invasive Hip Replacement through the Direct Lateral Approach *smith&nephew Introduction Prosthetic replacement of the hip joint

More information

BSI Road Show: September 8 th to 15 th, 2014

BSI Road Show: September 8 th to 15 th, 2014 BSI Road Show: September 8 th to 15 th, 2014 Post Market Surveillance (including PMCF): common non compliances Ibim Tariah Ph.D Technical Director, Healthcare Solutions Itoro Udofia Ph.D Global Head, Orthopaedics

More information

Hip Replacement. Department of Orthopaedic Surgery Tel: 01473 702107

Hip Replacement. Department of Orthopaedic Surgery Tel: 01473 702107 Information for Patients Hip Replacement Department of Orthopaedic Surgery Tel: 01473 702107 DMI ref: 0134-08.indd(RP) Issue 3: February 2008 The Ipswich Hospital NHS Trust, 2005-2008. All rights reserved.

More information

Robotic-Arm Assisted Surgery

Robotic-Arm Assisted Surgery Mako TM Robotic-Arm Assisted Surgery for Total Hip Replacement A Patient s Guide Causes of Your Hip Pain Your joints are involved in almost every activity you do. Movements such as walking, bending and

More information

Vigilance Reporting for Medical Devices in the EU. By Salma Michor, PhD, RAC

Vigilance Reporting for Medical Devices in the EU. By Salma Michor, PhD, RAC Vigilance Reporting for Medical Devices in the EU By Salma Michor, PhD, RAC 24 September 2009 Manufacturers putting medical devices on the market in the European Union (EU) must have a vigilance system

More information

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA ) )

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA ) ) Case3:10-cv-03886-EMC Document4 Filed09/03/10 Page1 of 18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Dana B. Taschner, Esq., SBN 135494 dbt@lanierlawfirm.com Lee A. Cirsch,

More information

Quality Management System Certification. Understanding Quality Management System (QMS) certification

Quality Management System Certification. Understanding Quality Management System (QMS) certification Quality Management System Certification Understanding Quality Management System (QMS) certification The medical device manufacturing sector is one of the most regulated sectors in which significant quality

More information

To the Members of the Senate Standing Committee on Health Inquiry,

To the Members of the Senate Standing Committee on Health Inquiry, 8 Herbert Street, St Leonards NSW 2065 PO Box 970, Artarmon NSW 1570, Australia Ph: 61 2 9467 1000 Fax: 61 2 9467 1010 South Pacific 1 October 2014 Senate Standing Committee on Health Inquiry Parliament

More information

No two knees are alike. That s why we personalize your surgery just for you. Zimmer Patient Specific Instruments. For Knee Replacement Surgery

No two knees are alike. That s why we personalize your surgery just for you. Zimmer Patient Specific Instruments. For Knee Replacement Surgery No two knees are alike. That s why we personalize your surgery just for you. Zimmer Patient Specific Instruments For Knee Replacement Surgery Table of Contents Here s how it works....2 Why does my knee

More information

frequently asked questions Knee and Hip Joint Replacement Technology

frequently asked questions Knee and Hip Joint Replacement Technology frequently asked questions Knee and Hip Joint Replacement Technology frequently asked questions Knee and Hip Joint Replacement Technology Recently, you may have seen advertisements from legal companies

More information