Use of implantable medical devices has been increasing the chances of survival from several serious ailments. Sometimes, the devices are the only treatment available for a certain condition. The U.S. Food and Drug Administration (FDA) is the Federal agency charged with approving drugs and medical devices. The agency will not approve a medical device unless it has evidence that its use will be safe and effective. The approval system has a variable level of scrutiny based on the degree of possible harm. One category of medical devices can be approved if they are substantially equivalent to an already approved device. These devices do not require clinical testing before being approved.
The FDA-approval process does not prevent all possible harm to patients. The FDA also has post-market safety monitoring in place once products have been made available for use by the public. Device failures reported to the agency can result in a recall of the device. Despite these precautions, patients are injured by medical devices every day.
There are a number of reasons why a medical device is defective. A flawed design, a low-quality component, or a flawed manufacturing process can all result in a defective product. Other medical device failures can occur post-manufacture. Errors in handling, such as exposing the device to temperature extremes or tampering with the packaging, can also compromise the device.
It can be difficult to detect a failed or failing device, especially if the failure is close in time to implantation surgery. The normal healing process can have symptoms that mirror those of a failed or failing device. All signs of failure should be investigated to minimize risk of devastating injury. Although many medical devices can be defective, there are several that commonly fail. These include hip replacements, knee replacements, transvaginal meshes, and birth control implants. Symptoms often associated with these types of medical devices include:
The most important thing to do when experiencing any of these symptoms is to seek medical attention immediately. You may want to consider getting a second opinion if you have any concerns about the doctor who performed the initial surgery. It is also vital to preserve evidence. If your symptoms require you to pursue a subsequent surgery, then obtaining copies of diagnostic tests before the second surgery is important. Although not a common practice, getting the actual medical device that has been removed could be very helpful in defending your case. Whether you can obtain this device will depend on the hospital, which may ban release of the device or require you to obtain a court order for its release.
If you received medical device treatment and are experiencing symptoms of failure, then reach out to one of our experienced Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler today. Call us at 215-569-4000 or contact us online to schedule a free initial consultation. Our office is conveniently located in Philadelphia, where we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.