Medical Implants

The MVP of the Medical Market

Close up of doctor's hand holding a medical implant device

Medical implants are man-made devices that are meant to replace missing biological structures, support damaged biological structures, have therapeutic purposes, collect diagnostics, and help maintain daily body functions.

Implants can be used within the human body or on the surface of the body either temporarily or permanently. There is a vast number of implants that aid with sensory issues, neurological disorders, cardiovascular disorders, contraception, pain-relief, alleviation of bone or joint issues, and a variety of organ dysfunctions.

So why are implants a game-changer? A huge reason is because medical implants are equipped with unique responsive polymers that are used to facilitate deployment and ensure the removal of devices with minimal damage to tissue. These unique polymers support important functions such as treating ailments, delivering drugs, controlling infections and monitoring physiological factors. Typically, the application of these polymers is divided by application areas that include:

Xray of human chest showing medical implant device
  • Cardiovascular Devices
  • Respiratory Devices
  • Surgical Devices
  • Dental Devices
  • Orthopedic Devices
  • Ophthalmic Devices
  • Gastrointestinal Devices
  • Drug Delivery Devices
  • Implantable Biosensors
  • Urogenital Devices

Since the first pacemaker implant in 1958 there has been a drastic advancement in all areas such as battery power, functionality, power consumption, and system delivery. One of the most beneficial advancements in the improvement of surgical implant devices and how they operate has to do with whole body donation. This is because body donation allows surgeons and medical professionals hands-on access to cadavers where they are given the opportunity to not only perfect surgical techniques but get an early introduction to new devices. This gives medical professionals a firsthand look with implants as they are created and introduced into the industry.

Another huge step forward for surgical implants was introducing different types of material that are tailor made for different necessities that help reach desired results. As implants improve, materials have become more lightweight, hypoallergenic, and biocompatible. Introducing new materials help ensure desired results with minimum discomfort, or risk of second surgeries, for patients. Current common materials for implants are:

Surgical Mesh – made from inorganic or biological materials that are woven to form a sheet. Surgical mesh can be used permanently or temporary to help support organs or other tissues.

Polyethylene – a common plastic that is often used for medical implants because it does not degrade in the body. Polyethylene is typically used for knee or hip replacement implants.

Titanium – a light, extremely strong, non-allergenic and biocompatible metal that is often used to make implants for dental surgeries. Lately, it has also been used for other medical uses such as hip implants, heart valves and bone screws.

Close up of doctor in operating room holding surgical mesh with a clamp

Polyurethane Foam – a fairly new addition to surgical implant materials, this foam is created by combining memory polyurethane foam with the bone tissue mineral “hydroxyapatite” and specifically encourages the regeneration of bone. They are most common in short term implants such as catheter tubing, wound dressing and injection molded devices.

Polylactic Acid – Often patients with titanium screws need to have a second operation to get them removed to combat this, surgeons opt for polylactic screws due to them being biocompatible and biodegradable.

3-D Printed Biomaterials – this technology uses a microfluidic approach and a device filled with stem cell “ink” that allows repair of damaged bone and cartilage offering precise replications of human tissue.

As advancements are made, the variety of available implants continues to grow rapidly. In just 2021 alone, there have been an impressive forty-one medical devices cleared and approved by the FDA that range from stent systems, standard implants, catheters, and gel implants. Annually some of the most common implantable devices remain to be:

1. Implantable Cardioverter Defibrillators

a. 800,000 people currently have ICDs
b. 100,000 are implanted annually

2. Artificial Hips

a. 2.5 million currently have artificial hips
b. 450,000 hip replacements are performed annually

3. Heart Pacemakers

a. Three million people currently have pacemakers
b. 200,000 pacemakers are implanted annually

4. Spine Screws, Rods and Artificial Disks

a. 500,00 spinal fusion surgeries are performed annually

5. Artificial Knees

a. 4.7 million people had knee replacements
b. Almost one million procedures are performed annually

6. Coronary Stents

a. More than eight million people currently have stents
b. Two million stents are inserted yearly

7. Ear Tubes

a. One in fifteen kids get ear tubes before age three
b. 500,000 ear tubes are implanted annually

8. Artificial Eye Lenses

a. Six million lenses are implanted annually

Medical implants are a thriving sector of medical technology with new implants emerging regularly in the market. It is currently dominating the market at an impressive $89 million in 2021. With versatility and innovation directly meeting patient needs, implants are proving to be a safe, effective, and prevalent option for a variety of conditions and patients.

Doctor getting ready to perform a surgical procedure on a woman's eyes
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Research For Life - Understanding Whole Body Donor Consent

Hello, my name is Garland Shreves, CEO of Research For Life. I want to take a moment to discuss some very basic information with you regarding consent forms, in general, that you may encounter when considering to donate to a whole body donor organization.

First and foremost, you need to understand and read the consent form, also known as the authorization form or document of gift, so you know what you are consenting to.  Ask questions of the organization if you don’t understand something. 

 All states require, under the Uniform Anatomical Gift Act, that consent be granted by an authorized agent of the donor or self-authorization before death.

Each state defines who in the consenting class has the most authority to direct donation. Such as the medical power of attorney, spouse, children, grandchildren, siblings, etc. and differs slightly in each state. 

Consent may be given by means of a verbal recorded consent or by a written document of gift.

Research For Life uses a written consent form which can be found on our website.

Understand that the donor or authorizing agent is giving the body to an organization. Once given it belongs to the organization to use in accordance with the consent form.

In other words, the donor organization is free to use the donor provided it does so within the terms

of the consent, it may not use the donor in a manner not consented too.  

The consent may state how the body may be used.  Educational and/or research purposes or some other purpose may be stated or in the discretion of the donor organization.

Research For Life provides cadavers and/or anatomical specimens for education and research purposes and does not do ballistic testing.

The consent may state that the body will be used in whole or in parts. It may also state that the anatomical parts may be used domestically and or internationally.

And most consents will cover some basic things like consent to test the donor for diseases and order medical records to help best determine the medical suitability for the donation.

The consent may also touch on issues like for profit or nonprofit status and if the donor or anatomical specimens will be used by one or more or both types of entities.  Remember that regardless of an organizations tax status they all charge fees to end users who order anatomical specimens and offer those specimens to both for profit and nonprofit entities.

From the very start of the donation process costs to the donor organization begin. 24-hour answering service, transport team to respond 24/7, qualified trained staff paid a livable wage with benefits and retirement, electric, gas, phone, insurances, building payments, maintenance, medical director, and regulatory requirements, and cremation fees. And these are just some of the expenses that an organization may have to cover.

Another item you may see on most authorization forms is a release of liability, a hold harmless agreement, excluding misconduct of course.  

Research For Life states clearly it will not and donor or agent agrees that Research For Life will not be held responsible for acts of third parties in connection with the donation.

Another item that reduces a donor organizations liability is the Anatomical Gift Act prohibits criminal, civil or administrative actions provided there is no intentional misconduct on the part of the donor organization. In other words, if the donor organization acted in good faith it is immune and provided some protection from lawsuits.

Another important part on a consent form is the person signing the authorization attests (affirms) that they have the authority to direct the donation. The donor organization accepts the authorizing agent’s authority in good faith barring any information known to it at the time of donation that would contradict the authority of the person authorizing donation.    

Remember, should you decide to register, tell your family and friends about your decision.

Also, the donation authorization form is not valid until notarized or signed by two witnesses; one witness must be non-family or disinterested party. 

Consent forms contain other important information that you need to read and understand.

All documents of gift or authorizations can be cancelled prior to death.

I want to thank you for taking the time to watch this video and I hope it helped provide you with some basic information regarding whole body donation consent forms.  Thank you.