If you received an implant that may be defective, such as a hip or knee implant, or mesh, the best way to identify your implant is to check medical records. Drugwatch can help walk you through the process.
Tens of thousands of patients are stuck in the difficult situation of hearing about a defective medical device — such as a total hip implant, knee implant or transvaginal mesh implant — but not knowing which product they had implanted during a recent surgery. When a medical device is recalled, how should patients react? And how can they find out which implant is inside of them?
Beginning in 2014, some medical devices used in the United States now carry a unique device identifier (UDI) that allows patients, health care providers, manufacturers and federal regulators to track each device. With the new program, problems could be identified more quickly and recalled products could be tracked down and handled efficiently. Patients could rest more securely because they would be able to identify which product was used in their surgery. Patient information would not be attached to the UDI. By 2018 or thereafter, every medical device could be required to carry a UDI.
For now, patients who have a problematic implant should first try to secure their medical records. If that doesn’t work, a qualified attorney can provide counsel.
How to Identify Your Hip Implant, Knee Implant or Mesh Implant
The best way to identify your implant is to request your medical records, including the operative report and implant record, by contacting your doctor or the hospital where the surgery was performed. You’re looking for the manufacturer name, product name, model number and lot number. Retaining these records can take time and may be costly and troublesome, but retrieving this information is important.
If you suspect you have a recalled implant, or if you’re experiencing complications and don’t know which product you have, consider contacting a medical devices attorney. These trained professionals can determine whether you have a legal case, and often can access medical records at a much faster pace.
Your billing information from the insurance company may also indicate the type of implant you were given. If you lost your billing information, contact your insurance company and ask for another copy.
Some patients receive medical device ID cards that enable them to get through airport security in the event their hip or knee implant sets off the metal detector. Unfortunately, these identification cards don’t always provide information about the device or manufacturer.
If you have suffered complications from a defective hip or knee implant, and you are facing revision surgery, talk to your doctor about keeping the defective implant so you can clearly identify it. You have a right to keep the implant, and the surgical team can clean it and save it for you.
If you wish to pursue legal action against the manufacturer of the implant, having possession of the product may be beneficial to any claim you may file. You may want to find a good lawyer before undergoing revision surgery. Your attorney will tell you if and when the defective implant is needed.
For complications following transvaginal mesh surgery, talk to your doctor as well as a qualified attorney. You likely won’t be able to save any part of the mesh product, but it’s important to know your rights before undergoing revision surgery.
Medical Device Recalls and Litigation
In addition to identifying your implant, it’s important to become familiar with any recalls of medical devices. One of the largest hip recalls occurred in 2010, when DePuy Orthopaedics pulled its ASR XL Acetabulum System and ASR Hip Resurfacing System from the market. If you received an ASR hip product or a different defective product, it’s best to talk to a qualified attorney before contacting the manufacturer directly. If you’re not experiencing pain or any other symptoms but know you received a recalled hip implant, you also may have legal options.
|Other hip recalls that you need to be aware of:|
|Stryker Orthopaedics recalled its Rejuvenate and ABG II modular-neck hip stems.|
|Zimmer Holdings briefly recalled its Durom Acetabular Component (Durom Cup).|
|Smith & Nephew recalled the metal liner component of its R3 Acetabular System.|
Many other cases alleging patients were harmed by hip replacements are still pending across the U.S. A federal jury in March awarded a record $502 million to five Texas residents who blamed their severe injuries on defective implants. Meanwhile, if you had knee-replacement surgery, you need to be aware that in 2010, Zimmer recalled some of its NexGen MIS Tibial Components.
|Halts of transvaginal mesh products include the following:|
|Johnson & Johnson’s Ethicon unit stopped selling its Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secure and Gynecare Prosima Pelvic Floor Repair System Kit.|
|C.R. Bard Inc. has stopped selling its Avaulta Plus mesh product.|