FDA Medical Device Bans
The FDA website contains information on medical device bans. According to that site, a medical device ban is a total prohibition on the current and future sales, distribution, and manufacturing of a medical device. The FDA has the authority to ban a medical device intended for human use if it finds, on the basis of all available data and information, that the device presents a substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling.
This authority has been used only rarely by the FDA. The FDA has banned prosthetic hair fibers. The FDA found there was no public health benefit to this device. This device presented a substantial deception to patients or users about the benefits of the device. The prosthetic hair fibers did not stimulate hair growth nor conceal baldness, but could actually cause serious infections, illness, and injuries from their implantation.
The FDA has also banned powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications.
The FDA has proposed a ban on electrical stimulation devices (ESDs), intended to reduce aggressive or self-injurious behaviors, because they present an unreasonable and substantial risk of illness or injury to the public. ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behaviors. Many people getting exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. A number of significant psychological and physical risks associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, and tissue damage. In addition, there is a risk of errant shocks from a device malfunction.
The FDA website says that “The FDA makes the determination to ban a device by analyzing and weighing the risks and benefits the device poses to individuals. This analysis may include: • Identifying and studying the device, including assessing adverse events,
• Analyzing the risks and benefits posed by alternative devices and treatments being used in current medical practice,
• Analyzing whether a change in labeling on the device mitigates the risk,
• Evaluating the medical literature,
• Conducting a panel meeting with outside experts,
• Discussing concerns with professional societies, and
• Reviewing information from health care professionals and patients.
The FDA can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required degree of risk based on all available data and information.
The FDA may initiate proceedings to ban the device if:
• the device presents substantial deception in the labeling or an unreasonable and substantial risk of illness or injury, and
• such deception or risk cannot be, or has not been, corrected or eliminated by labeling or a change in labeling.
If the FDA decides to initiate proceedings to ban a device, a notice of proposed rulemaking is published in the Federal Register.
A proposed ban is the FDA's statement of intent to ban a device. In a proposed ban, the FDA outlines its assessment of the benefit-risk profile of the device. Specifically, a proposal to ban a device requires a summary of the:
• Agency's findings regarding substantial deception or the unreasonable and substantial risk of illness or injury;
• Reasons why the FDA initiated the proceeding;
• Evaluation of the data and information the FDA obtained under provisions (other than section 516) of the FD&C Act, as well as information submitted by the device manufacturer, distributer, or importer, or any other interested party;
• Consultation with a panel of experts that classify a device, if conducted (see the Advisory Committee webpage for more information about FDA Panel Meetings);
• Determination that labeling, or a change in labeling, cannot correct or eliminate the deception or risk;
• Determination of whether, and the reasons why, the ban should apply to devices already in commercial distribution, sold to ultimate users, or both; and
• Other data and information the FDA believes are pertinent to the proceeding.”
Although it is tempting to trust your doctor, and avoid the individual research, our experience has shown that neither doctors, the FDA or the pharmaceutical industry can be fully trusted with your health. Please contact us at 1(855) 464-0808 or for a free legal evaluation of your claims today!
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