Implants and Explants

April 10, 2019 | Healthcare Risk, Quality, & Safety Guidance

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A medical implant is a device that is placed permanently or temporarily inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts, while others perform important functions such as delivering medication, monitoring bodily functions, or providing support to organs and tissues. (FDA "Implants") Medical implants range from mechanical devices, such as intraocular lenses, cosmetic implants, orthopedic hardware, stents, and joint replacements, to highly complex devices such as retinal implants, artificial hearts, implantable cardioverter-defibrillators (ICDs), and cochlear implants.

In the United States, an estimated 370,000 cardiac pacemakers (CDC) and more than one million artificial joints and knees (Scutti) are implanted each year. In 2011, implantable device sales totaled around $43 billion, an amount that was projected to grow to $74 billion in 2018 (Parmar). As the aging population grows, increasing numbers of patients will require implants such as replacement hips and knees, and healthcare providers will rely on implants to prolong their patients' lives and to treat their clinical conditions.

Medical device implants can save or prolong lives or improve quality of life, but they may also be sources of significant risk to patients. Several risk, regulatory, and patient safety issues illustrate the need for providers and healthcare organizations to adopt risk management strategies for managing implanted and explanted medical devices (i.e., explants). Nearly all implants are prone to quality problems as well as material or design defects that may result in their failure or malfunction, potentially causing serious or fatal consequences to patients. For example, consider the following cases:

FDA: Implantable Cardiac Devices Are Vulnerable to Cybersecurity Threats

Lessons Learned from FDA's Recall of a Pacemaker That Was Susceptible to Hacking

In many cases, the physician—not the facility where the implant procedures are performed—has control over which devices to implant, and the hospital pays for the devices. Although this type of arrangement has many benefits (e.g., it suits physician preference and allows physicians to implant devices with which they are familiar and comfortable), disadvantages exist both for the facility and for patients (Lind "Understanding").

Physicians are often not aware of the cost of the devices they implant. A 2014 survey of orthopedic physicians found that just 21% correctly estimated the cost of orthopedic devices within 20% of their actual costs—despite the...

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