Injured Because Of A Defective Medical Device?
Medical devices are implanted in the patient usually by way of invasive, painful surgery or injection. Some such as hip implants, knee implants, or transvaginal mesh products become a part of the patient’s body. When the medical devices stop working as expected or causes harm, it is not a simple matter to repair or heal. In most cases, another invasive, painful revision surgery is required. This can result in extended recovery time and additional costly therapy. In certain cases, the defective device might cause permanent damage either to the patient’s organs or bones which may make recovery difficult if not impossible. Their quality of life may be less than they experienced prior to having the medical device implanted initially. Manufacturers of medical devices are expected to test all devices before releasing them to the public, but sometimes the premarket studies do not include enough participants to adequately judge the results among the general public.
If you have been injured by a defective hip replacement or other medical device, you may have a financial claim against the manufacturer!
You are urged to contact us immediately as there may be a time limit for which you can file for your case. We offer free confidential consultations and will work with you through every step of the process. Call now toll-free – 855-776-5299 or fill out the easy contact form on this page and a member of our legal team will be in touch.
Medical devices for which we are currently filing claims:
AlloDerm Hernia Mesh -Claims are being filed for patients implanted with AlloDerm after 2005 for hernia repair (ventral, abdominal, inguinal, incisional, etc.) or abdominal reconstruction surgery such as TRAMS flap surgery and have experienced failure or corrective surgery. Patients treated with AlloDerm have reported abscesses, infection, inflammation and swelling which in some cases, have resulted in removal of the graft.
Transvaginal Mesh – Transvaginal mesh may not be more effective in certain situations than non-mesh repairs and that is may expose patients to a greater risk of adverse side effects, including persistent vaginal bleeding, discharge, pelvic pain, or pain during sex.
GranuFlo Dialysate Concentrate – GranuFlo is prescribed for use in the treatment of acute and chronic renal failure during dialysis. GranuFlo is manufactured by German manufacturer, Fresenius (FMC). There have been reports of kidney patients suffering from cardioplumonary arrest and death shortly after undergoing dialysis treatment due to the incorrect dialysate concentration.
Power Morcellator – J & J has suspended sales of the Ethicon Laparoscopic Power Morcellator after finding that they may spread cancer when used in uterine fibroid surgery. Men may also be at risk if used during a kidney or spleen procedure.
DePuy ASR Hip Replacement and DePuy ASR XL Acetabular Hip Replacement Systems – Manufactured by DePuy, these metal-on-metal implants were recalled due to a flaw in the design which can cause excessive friction between the metal parts.
Stryker Rejuvenate and ABG II modular-neck hip stems – These metal-on-metal pieces by Stryker can corrode and deteriorate releasing metal toxins into the bloodstream and surrounding tissue.
Stryker Trident Acetabular PSL Cup and Stryker Trident Hemispherical Cup – Stryker recalled these hip implant components due to complaints that they failed to function, and have poor fixation.
Zimmer Hip Replacement System – Zimmer’s hip replacement implants may require a second surgery due to the high risk of loosening or metal poisoning.
Mirena – Mirena is an intrauterine device (IUD) consisting of a T-shaped plastic body with a removal thread. If you have had this birth control product removed or are scheduled for removal of the device due to migration, you are advised to contact us now as you may have a claim against the manufacturer. Also investigating claims for patients with Mirena that have been diagnosed with breast cancer.
Unsafe Medical Devices
You may have need for a defective medical device lawsuit lawyer if you have been injured after treatment with certain implants, mesh products, or IUD’s. Thanks to modern scientific advancements, there are now many approved medical devices available to treat injuries and diseases.
Patients suffering with heart problems, joint trouble, and many other medical complaints have had their lives vastly improved as a result of the time and dollars spent on research. Medical devices such as hip and knee replacements, transvaginal mesh products, pacemakers, stents, are becoming commonplace treatment options. While most are relatively safe and effective, sometimes the same medical devices we rely on to improve our quality of life may cause serious and even deadly complications. They may have been inadequately tested before being released or simply defective. These unsafe medical devices might have been rushed to consumers in hopes of satisfying a need in the medical community or maybe to increase profits for the manufacturer. While most medical devices are safe and effective for their intended uses, a few have resulted in injuries or even death. In recent years, several medical devices have been pulled from the market after reports were sent to the US Food and Drug Administration (FDA) complaining about serious injury or death for thousands of Americans. The same patients that expect a reasonable assurance of safety and effectiveness for their treatment are now suffering as a result of unsafe or defective medical devices.
Medical Devices and the FDA
Medical devices for use and sale in the United States are governed by the FDA. Most manufacturers are careful to correctly identify all medical devices presented to the FDA for approval. However, it is possible for the medical devices to be classified in such a manner as to decrease the FDA’s scrutiny. By doing so, it may become easier for the manufacturer to achieve FDA approval without undergoing costly, time consuming research and clinical trials. Just because a product has FDA approval does not guarantee that the medical devices are safe and also does not protect the medical device manufacturer from liability. Devices are classified by the FDA into Class I, II, or III. The regulatory control increases from Class I to Class III which means most Class I devices do not require premarket approval. In addition, if a device is considered to be substantially equivalent to another item that has already received FDA approval, it only needs to demonstrate that it is as safe and effective as the previously approved device. If a device is found to be not as safe or effective as indicated, the FDA may issue a warning or ask for a recall. A recall means that the products are in violation of the laws administered by the FDA. Most manufacturers will voluntarily initiate a recall if needed as it is their responsibility to protect the public from defective products.
What You Should do if You are Injured by Medical Devices Most patients rely on their doctor’s judgment and advice for medical treatments. When using medical devices, it falls upon the doctor or healthcare provider to inform the patient of all the possible risks if they choose the recommended treatment. This in turn means that the medical profession relies on updated, reliable information from the medical device manufacturers. Manufacturers of medical devices therefore hold positions of trust. If a patient suffers harm as a result of a defective product, they should be held responsible. If you or a loved one has been injured as a result of implanted medical devices which have been recalled or are in anyway defective, please contact our medical devices attorneys as soon as possible. The legal team at D. Miller & Associates, PLLC has experience in the complex legal and scientific aspects of medical devices litigation and we will work to uncover aggressive product development and marketing practices that may have caused patient harm. If you have used or been exposed to any of these medical devices, we can help. There may be statutes of limitations involved in your case, so contact us as soon as possible to protect your rights! Medical devices cases are extremely complex. You need the experience and “know how” of the medical devices lawyers at D. Miller & Associates, PLLC.