Wednesday, 22 of November of 2017

Category » Hip implants

Update on the DePuy Hip Replacement Lawsuit

 

 

DePuy ASR

An Articular Surface Replacement, removed from a patient.
Photo Credit: The New York Times

Metal on metal implants for hip replacement surgery have been the subject of intense scrutiny and media attention for some time now. Bloomberg Business News and the New York Times recently reported that Johnson & Johnson has “tentatively agreed” to an estimated $4 billion settlement to settle some 7,500 lawsuits against its DePuy Articular Surface Replacement (ASR) hip implant device.

Metal-on-metal implants were initially thought to be a breakthrough product that would last longer, offer greater stability and improve bone conservation, but unfortunately that is not turned out to be the case. In January of this year, the FDA issued a safety bulletin, citing growing clinical evidence that shows a failure rate two to three times that of non-metal-on-metal devices.

In addition, the impact of metal rubbing on metal can cause tiny metal particles to flake off, causing damage to muscle and bone, as well as a high level of metal ions in the blood. Many patients have been forced to undergo hip revision surgery to remove the flawed implant and replace it with a different design.

Thousands of patients have filed lawsuits against DePuy and other manufacturers of metal implants, claiming the devices were defective and have harmed their health. When formal announcement in the DePuy ASR case is released some time this week, it is expected to be one of the largest product liability claims to be paid involving a medical device. The New York Times reports that only patients who have undergone revision surgery to replace the defective ASR implant will be included in the current settlement.

If you are dealing with chronic hip pain from osteoarthritis or are concerned about a hip replacement that you had in the past, please feel free to call our office at 239-936-6778 to schedule a consolation. For more information about joint replacement or other orthopedic-related conditions, go to www.kaganortho.com.


What You Need To Know About Metal on Metal Hip Implants

There have been many media reports lately about metal-on-metal hip implants and the potential risk they pose. It can be confusing for patients and families to sort through the information and to know what action, if any, should be taken.

First, it’s important to understand how safe and successful hip implants have been for many years. Second, not every patient who has undergone hip replacement received a metal-on-metal implant. Implants may be made of plastic, ceramic or metal.

When metal-on-metal implants were first introduced, it was originally thought they were a superior technology due to their durability and other factors. Now we know they can cause serious complications. When the two metal implants rub against each other, tiny metal particles can flake off and lodge in the tissue or even enter the bloodstream and travel to the organs.

Metal on metal implants also have a higher than normal failure rate, possibly due to a build-up of metal particles in the tissue or an allergic reaction to the metal in the implants.

What’s being done? The FDA called a meeting this summer to discuss these concerns with experts from around the country. Final recommendations have not yet been made, but use of metal on metal implants has declined significantly.

What can patients expect? Only a very small percentage of patients are experiencing symptoms, but physicians are monitoring everyone who received a metal on metal implant to check for signs of adverse reactions. If you are experiencing new or significantly worse symptoms – swelling, pain, numbness or change in ability to walk, call your doctor. Blood tests can check levels of metal ions in the blood and X-ray or MRI may be useful.

To discuss your concerns with an experienced orthopedic surgeon who has performed thousands of joint replacement surgery procedures, please call 239-936-6778 or for more information go to www.kaganortho.com.


Metal-on-metal hip implants: What patients need to know

While surgery is not always the first or best option for every patient, hip replacement surgery to replace the diseased hip joint with an artificial joint may be advised to help relieve pain, increase motion, and get you back to enjoying many normal, everyday activities.

For patients contemplating hip replacement, there are several options for implants. Replacement joints are made of many different materials including plastic, ceramic and metal. Sometimes the ball and socket are made with the same materials and other times, the two are made of different materials. When I determine that hip replacement surgery is the next best step for my patients, I will select an implant based on the patient’s body structure, medical history, and lifestyle.

Recent recalls of metal-on-metal hip implants have prompted more discussions and concerns between surgeons and patients about the types of products available and materials used. About a year ago, the U.S. Food and Drug Administration (FDA) issued a public health communication about hip replacement components that have both a metal ball and a metal socket (metal-on-metal hip devices), due to the number of patients who required a second hip replacement procedure, called a revision surgery.

Symptoms of implant failure may include hip/groin pain, local swelling, numbness or changes in your ability to walk. However, there are many reasons a patient with a metal-on-metal hip implant may experience such symptoms and it does not mean your implant must be replaced but it is important that you contact your surgeon to help determine the cause.

There have also been cases where metal particles from the implant caused a reaction around the joint, leading to deterioration of the tissue surrounding it, loosening of the implant, and failure of the device. In addition, some metal ions from the implant may enter into the blood stream. There have been a few recent case reports of patients with metal-on-metal hip implants developing a reaction to these ions and experiencing medical problems that might have been related to their implants, including effects on the nervous system, heart, and thyroid gland.

Most recently, the FDA issued orders to hip manufacturers requiring post-market surveillance studies to monitor adverse events after a device has been approved by the FDA. Information for patients on the recall and a list of frequently asked questions can be found on the FDA website.

If you are uncertain about which type of implant you have or if you experience pain or other medical concerns following joint replacement surgery, you should contact the orthopaedic surgeon who performed your procedure.

When discussing your options for hip surgery with your surgeon, some questions you should ask include:

  • What are the risks and benefits of each type of hip implant system (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, and ceramic-on-ceramic devices)?
  • What is the surgeon’s personal experience and outcomes with metal-on-metal hip systems?

If you are not satisfied with the surgeon’s responses or have concerns about the surgery, consider seeking a second opinion. Ultimately, it is the “joint” decision of the surgeon and patient on which course of treatment and type of implant is best.

If I can be of assistance, please call my office at 239-936-6778 or visit www.kaganortho.com/.


Questions and Answers About Metal-on-Metal Hip Implants

Do you have questions about metal-on-metal hip implants and recent recalls?  The American Academy of Orthopaedic Surgeons has put together some frequently asked questions to help: http://www.orthoinfo.org/topic.cfm?topic=A00625.

 If you are concerned or have questions, please call and make an appointment at 239-936-6778 or visit http://www.kaganortho.com/.



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