Medical Devices | Association for Medical Ethics

Articles: Medical Devices

The FDA regulates as “medical devices” things that are used internally or externally in patient care, but aren’t exactly drugs – this includes injectibles (like Botox), devices inserted into the body during surgery (like pacemakers) and things that are used outside of the body (like neonatal bassinets). If you have or need one of these devices, you should find out all the relevant information that there is about them. You can start by reading an article about it.

What your doctor may not be telling you about Botox

Over the past 20 years Botox has become a familiar name. Made popular by celebrity usage and apparently amazing results, a Botox injection can be seen as a quick and economical (although temporary) alternative to a face lift. But is Botox right for you? Take the time now to educate yourself about this drug labeled a “liquid facelift” and decide for yourself. A bit of research can not only save your wallet, but could also save your life.

What your doctor may not be telling you about Restylane

Restylane™ is a transparent gel form of hyaluronic acid that has been approved by the FDA for injection into a patient’s lips to increase their size, or into facial tissue around the nose and mouth to reduce wrinkles and folds.¹

What your doctor may not be telling you about Juvederm

JUVÉDERM® is an injectable gel used for the smoothing or filling of wrinkles and lines. Juvederm is the trademark name for a cosmetic filler containing hyaluronic acid.¹

What your doctor may not be telling you about Lap-Bands

The lap band is a silicone band that is placed around the upper part of the stomach.¹ This band restricts the amount of food that enters the stomach. The mechanics are simple and consist of an inflatable gastric band, tubing, and an access port.

What your doctor may not be telling you about Lasik

A basic grasp of how the eye works will assist in understanding the LASIK process. Much like a camera, the shape of the eye, and power of the lens determines how well the eye will bend light, and produce a sharp, clear image.

What your doctor may not be telling you about Synthes Synex II Central Body Spine Implants

Synex II Vertebral Body Implant is a device used in the thoracic and lumbar spine (T1-L5) to replace a damaged, collapsed, or unstable bone in the spinal column body.¹ Simply put, this device is intended to assist the physician in repairing spinal columns that have been damaged due to the removal of tumors, or injury to the vertebrae such as fracture. The purpose of this device is to stabilize the spinal column, while providing the patient with an acceptable range of motion.²

What your doctor may not be telling you about DePuy ASR Metal on Metal Hip Replacement System

The DePuy ASR is a total hip replacement system, where your existing hip joint is removed and replaced with an artificial ball and socket system designed to mimic a natural hip joint. A metal socket is placed in the pelvis where the original hip socket was, and the femur is implanted with a ball attached to a stem. In most current hip replacement products, the lining of the socket is made of plastic or ceramic. The ball is usually made of metal or ceramic. There is some wearing down of the lining that is expected to occur over many years as with the friction of the joint moving with these “metal on poly (plastic) or ceramic” joints. In nature, your hip has cartilage to perform this function.¹ However, a new product of “metal on metal” where BOTH the ball AND socket were metal was marketed and implanted in thousands of patients. This was called the DePuy ASR system.

What your doctor may not be telling you about CooperVision AVAIRA Toric and Sphere Soft Contact Lenses

These soft contact lenses were prescribed for the correction of myopia (nearsightedness) or hyperopia (farsightedness) with astigmatism. The lenses are indicated for patients who may or may not have had their natural lens of their eye altered through Lasik or similar surgery. They are not recommended for patients who have had previous eye diseases.¹

What your doctor may not be telling you about Trans-vaginal Pelvic Mesh

Trans-Vaginal Surgical mesh is a permanently implanted synthetic mesh. It used to strengthen the deteriorated vaginal wall to restore pelvic organ prolapse. In the case of urinary incontinence, it is used to support the urethra.¹