Medical Device Recalls
Though they can be just as dangerous to patients when defective, medical devices are often approved with less scrutiny than prescription drugs. In fact, many high-risk devices never undergo clinical trials nearly as rigorous as those required even for low-risk pharmaceutical products.
Every year the FDA issues hundreds of warnings and recalls for medical devices. Complications from these devices can worsen the condition they intended to treat and lead to life-long injuries or even death.
As soon as a company learns that a medical device they manufacture or distribute is potentially defective (either in its functioning or because it fails to adequately warn of a risk), they are required to notify the Food and Drug Administration, which then determines if it is necessary to issue a warning or recall.
Recalls do not necessarily mean that a device must no longer be used or that a device which has been implanted must be removed. Sometimes the device just requires an adjustment, correction, or to be checked.
The FDA has three classes of recalls:
There is a reasonable chance that the device will cause serious health problems or death.
There is a slight chance the device will cause serious health problems and any issue is likely to be temporary or reversible.
There is little to no chance the device will cause any health problem.
Patients that have used or are actively using a medical device with any class of recall should speak to their doctor regarding its safety, and regardless of the severity of the risk, no medical device is appropriate for FDA approval if the risk to public health outweighs the therapeutic effect of using the product or if the risks are not appropriately explained to both healthcare providers and patients.
Devices With Current FDA Warnings or Recalls
Also known as Yasmin or Ocella, this implantable intrauterine device (IUD) for birth control can potentially cause blood clots, which can lead to life-threatening conditions like deep vein thrombosis and pulmonary embolism.
An IUD from Teva Pharmaceuticals called Paragard was recalled because it has been linked to cases where it broke upon removal and caused injuries which required surgery and risked the patient’s future fertility.
Used to treat pelvic organ prolapse, stress urinary incontinence, and hernias, surgical mesh products, like transvaginal mesh, can erode through organs and soft tissues, leading to problems sitting, walking, or engaging in sexual intercourse.
Hip replacement is a safe and common procedure, but not all artificial hips are equally safe. Warnings have been issues for products manufactured by Johnson & Johnson, DePuY, Stryker, Biomet, Zimmer, Wright, and Smith & Nephew due to potential complications such as high metal toxicity in the blood, severe pain in the hip and groin, swelling, tissue damage, and/or muscle damage.
Like artificial hips, metal-on-metal knee replacement devices have been implicated in complications where small particles of metal escape into surrounding tissues causing toxicity and severe adverse effects. Additionally, the cement products used to install artificial knees can potentially deteriorate over time, causing the device to come loose.
Alaris Infusion Pump
Pacific Medical Group recalled the Alaris Infusion Pump module model 8100, a device that delivers fluids, such as drugs or nutrients, into a patient’s body. The device may be prone to cracking, leading to too much or too few of a vital fluid being delivered during critical procedures.
FiberCel Surgical Bone Product
Aziyo Biologics’ FiberCel is used in bone-grafting procedures to induce the growth of new bone. However, a contaminated lot of FiberCel has been linked to post-surgical tuberculosis infections.
Cordis Carotid Artery Device
The Precise PRO Rx US Carotid System from device manufacturer Cordis is used to treat narrowed carotid arteries (blood vessels in the neck which supply blood to the brain). It was recalled because of the potential for the delivery system to malfunction, which could cause a stroke.
A mechanical failure can result in an endcap separating on the NuVasive MAGEC, a magnetic device prescribed to treat early-onset scoliosis (curvature of the spine), which can lead to increasing levels of back pain.
BD (Becton, Dickinson and Co.) recalled its ChloraPrep applicator, a device which preps a patient’s skin prior to surgery to prevent infection, due to a manufacturing defect that may result in broken glass and solution escaping from the applicator.
Philips CPAP Machines
Continuous positive airway pressure machines from Philips, which treat sleep apnea and other breathing issues — as well as other Philips Respironics products, such as ventilators and bilevel positive airway pressure (BiPAP) machines — were recalled due to the discovery that there was an unreasonable risk of a patient inhaling particles of the sound abatement foam used in them.
Medtronic recalled its HeartWare Ventricular Assist Device (VAD), a mechanical circulatory support device which uses both implanted and external devices to assist in the circulation of blood throughout the body. A connector plug can become damaged due to normal wear and tear and cause the device to stop functioning.
Devices from several manufacturers, including Medtronic and Johnson & Johnson subsidiary Ethicon, used to close wounds with staples instead of sutures have been recalled due to an elevated risk of malfunction which can lead to fistulas (abnormal connections between two body parts), excessive bleeding, and other avoidable harms.
Get Compensation for an Injury Caused by a Defective Medical Device
The companies that manufacture and distribute medical devices have a duty to prevent defects and keep patients safe.
An experienced product liability lawyer can assist patients who have been affected by a recalled medical device in determining if they have a valid legal claim; gathering evidence for their case, including expert medical testimony; and pursuing fair compensation from the medical device manufacturers through settlement negotiations and courtroom verdicts.
If you were injured by a medical device or other medical product, Pond Lehocky Giordano offers a completely free and confidential consultation to discuss your case. For more information, call 1-800-568-7500 or fill out the contact form on this page.
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