Smith & Nephew is a multinational, British-based manufacturer of medical devices. The history of the company dates back 160 years to a man who founded the business and worked with his nephew to provide chemicals and pharmaceuticals. The biggest part of the modern business is the development and manufacturing of joint replacement systems. Smith & Nephew makes artificial knees, shoulders, and hips.
With billions of dollars in sales each year, Smith & Nephew is a successful medical device business. Several of its artificial hip systems have caused problems, though. There have been recalls of some of these devices and complications caused to patients including dislocations, fractures, and infections. The company has also faced legal fees in the U.S. over illegal practices involving kickbacks.
Smith & Nephew – Overview
Smith & Nephew is a medical device development and manufacturing company, which was founded in 1856. The headquarters for the modern business are in London, but the devices made are sold in more than 100 countries around the world. Smith & Nephew employs around 15,000 people in various facilities and in 2015 took in $4.6 billion in sales revenues.
The company makes products that fall into six medical categories: wound management, sports medicine, trauma and extremities, ear, nose and throat, gynecology, and orthopedic reconstruction. It is this last category that includes joint replacement systems. The company’s hips have caused complications, especially those with metal-on-metal components.
These metal hip components are made with a proprietary metal alloy, first introduced by Smith & Nephew in 2003. The alloy is called OXINIUM and is made from oxidized zirconium. The company claims that this material is superior because it resists wear like ceramic, but is strong like metal. OXINIUM is used in the company’s VERILAST line of artificial hips.
The history of Smith & Nephew goes back to 1856 when Thomas James Smith opened his first pharmacy in Hull in England. He died in 1896, but his nephew Horatio Nelson Smith had taken over the business, and Smith & Nephew was born. The company’s medical device business really took off at the start of World War I when it was contracted by the British government to provide field dressings and surgical equipment. Over the decades Smith & Nephew acquired a number of smaller companies and grew into the large, multi-national company it is today.
The R3 Acetabular Hip System
Smith & Nephew developed the R3 Acetabular hip system to give surgeons the ability to mix and match artificial hip components. The system has been in use in the U.S. since 2009 and is available with plastic, metal, and ceramic pieces. The different components include the cup, which replaces the acetabulum. This is the hip socket into which the ball or head of the femur fits to create the movable joint. The system also includes an artificial femur head and several different stems that connect the cup and the head.
The R3 system also includes several acetabular liners. These are liners that fit into the cup to allow surgeons to create an artificial joint that best fits individual patients. The cups may be made of plastic, but also carbide cobalt chrome, a metal alloy that Smith & Nephew claims causes less wear and friction as the joint moves.
R3 Acetabular Hip Complications
Smith & Nephew claims that the R3 system is designed to reduce friction, wear, loosening of the joint, and dislocation, and yet there have been numerous reports of problems with the hips. One issue is that the rubbing of a metal femur head against a metal cup or liner causes small pieces of metal to break off and get into the blood stream. This can cause irritation and even metal poisoning.
Another issue has been a high rate of revision with the R3 system. Revision is the surgery needed when a hip fails. The better and more durable a hip is, the lower the revision rate will be. More people than is normal have needed revision surgeries after having an R3 hip system implanted. As a result, Smith & Nephew recalled the metal cup liner in 2012.
The Emperion Hip System
The Emperion hip system created by Smith & Nephew, like the R3 system also includes interchangeable components to allow surgeons to create individual hip joints. In the Emperion system the stem that connects the cup to the femur head is made of titanium and it has caused problems in some patients. Although there are benefits to being able to change out the stem, it also seems to cause more fretting, corrosion, and breaks. Studies have found that the hip stem used in the Emperion system can break causing serious pain and a need for revision surgery in patients.
Faulty hip systems have not been the only problems faced by Smith & Nephew over the years. In 2007 the company had to pay $28.9 million in criminal and civil suits. The alleged crime was using kickbacks to push surgeons and doctors to buy their medical products. According to the criminal case the company violated Medicaid, Medicare, and federal anti-kickback laws by paying surgeons between 2002 and 2006. The company has been found guilty of similar practices in other countries.
Because of the violations Smith & Nephew was required to hire a compliance monitor to review corporate practices and policies and to ensure the company would comply with the terms of the settlement. The federal monitoring lasted for 18 months, but in 2012 the U.S. Department of Justice again required the company to hire a compliance monitor. Being monitored twice in a row is unusual.
Smith & Nephew has faced a lot of legal fees over illegal practices regarding its medical devices, but it may also face lawsuits from individuals harmed by their faulty hip systems. The company made claims about the sturdiness of its hip systems, but too many patients suffered failures that required revision surgeries. If you have been hurt by a Smith & Nephew hip you may have legal options to recover monetary compensation.
- http://www.tga.gov.au/alert/metal-liner-components-r3-acetabular-system-used-hip-replacements - about