Surgery: Procedures and Options : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Patients should alert their physicians or nurses who are providing them care, or hospital administrators, if they have concerns about their health-care workers' practices. All states have licensing and oversight bodies in their state health departments that respond to concerns and complaints brought by patients.

Patients should always provide their doctors with a complete health history, including:

• other medications (some drugs may increase the risk for infection)
• infections
• recent exposure to people or animals who might have infectious diseases
• travel to areas with high rates of infectious diseases.

If you become more ill after arriving home from a hospital stay and develop unexpected symptoms such as pain, chills, fever, discharge, or increased inflammation of a surgical wound, you should alert your doctor.

What's New in the Operating Room?

The following is a list of some of the latest advances available in surgical patient care:

Bispectral Index (BIS)

The BIS monitoring system was first cleared by FDA in October 1996 to monitor the state of the brain in the intensive-care unit, the operating room, and for clinical research. The system, which includes an enhanced electroencephalogram (EEG) monitor, analyzes a patient's brain wave pattern and converts it into a "depth of sedation" number between 0 (indicating no brain activity) and 100 (fully awake).

It's a popular belief that anesthesiologists use the device to reduce or prevent "awareness" during surgery. But FDA's Center for Devices and Radiological Health says the device has not been approved or labeled for monitoring to reduce awareness. It is intended only to monitor the state of the brain.

Scopolamine Patch

FDA initially approved the scopolamine patch, distributed under the brand name Transderm Scop by Novartis Consumer Health in New Jersey and manufactured by ALZA Corporation of Palo Alto, Calif., in December 1979 as a prescription drug to prevent nausea and vomiting associated with motion sickness. Following the manufacturer's removal of the product from the marketplace in 1994 due to manufacturing problems, FDA approved the drug again on Oct. 27, 1997, for the additional indication of preventing nausea and vomiting during or after surgery.

The small, Band-aid-like patch is placed behind the ear the night before surgery, or an hour before a Caesarean section. The medication in the patch goes through the skin directly into the bloodstream. It is not to be worn for more than three days, and is intended for a single use only.

Remifentanil

Approved by FDA in July 1996, remifentanil, marketed as Ultiva and manufactured by Glaxo Wellcome of North Carolina, is an analgesic for inducing and maintaining general anesthesia for surgery. It safely breaks down in the bloodstream and body tissues within minutes. Unlike other drugs that must be metabolized or broken down by the liver and kidneys, remifentanil gets broken down by enzymes in the blood and muscles. This means that the drug has a half-life of three to six minutes in the body, compared to 90 minutes or more for other drugs. That, in turn, results in the patient waking up and having the breathing tube removed considerably sooner.

Fibrin Sealants

A new class of blood-derived fibrin sealants, distributed by Baxter Healthcare Corporation, can stop oozing from small, sometimes inaccessible, blood vessels during surgery when conventional surgical techniques are not feasible. FDA approved the first of these sealants in May. The main active ingredient of fibrin sealants is fibrinogen, a protein from human blood that forms a clot when combined with thrombin — another blood protein that helps blood clot. The sealants, which form a flexible material over the oozing blood vessel, can often control bleeding within five minutes.

Questions to Ask Your Doctor Before You Have Surgery

The Agency for Health Care Policy and Research recommends you ask your physician the following types of questions before having surgery. The answers to these questions will help you be informed and make the best decision about whether to have surgery, by whom, where, and when. Patients who are well-informed about their treatment, according to the agency, are usually more satisfied with the outcome and results.

Why do I need the operation?

There are many reasons to have surgery. Some operations can relieve or prevent pain, others can reduce the symptom of a problem or improve some body function, and some surgeries are performed to diagnose a problem. Surgery can also save your life. When your surgeon tells you the purpose of the procedure, make certain you understand how the recommended operation fits in with the diagnosis of your medical condition.

Are there alternatives to surgery?

Sometimes surgery is not the only answer to a medical problem. Medicines or other nonsurgical treatments might help you just as well or more. Always ask your doctor or surgeon about other possible choices.

What are the benefits of having the operation?

Ask your surgeon what you will gain by having the operation. For example, hip replacement may mean that you can walk again with ease. Ask how long the benefits are likely to last. For some procedures, it is not unusual for the benefits to last for a short time only. There might be a need for a second operation at a later date. For other procedures, the benefits may last a lifetime. Be realistic. Some patients expect too much and are disappointed with the results.

What are the risks of having the operation?

All surgery carries some risk. This is why you need to weigh the benefits of having the operation against the risk of complications or side effects. There is almost always some pain with surgery. Ask how much you can expect and what the health-care providers will do to reduce pain.

What if I don't have this operation?

Based on what you learn about the benefits and risks of the operation, you might decide not to have it. But you must also decide what the likely outcome will be for the condition — it could stay the same, continuing to cause pain, it could get worse, or it could clear up on its own — if you choose not to have the surgery.

What is your experience in performing this surgery?

One way to reduce the risks of surgery is to choose a surgeon who has been thoroughly trained in the procedure you are considering. Besides asking the surgeon directly, you can also ask your primary-care physician about the surgeon's qualifications.

What kind of anesthesia will I need?

Your surgeon can tell you whether the operation calls for local anesthesia (a numbing of only a part of the body for a short time), regional anesthesia (a numbing of a larger portion of the body for a few hours), or general anesthesia (a numbing of the entire body for the entire time of the surgery) and why this form of anesthesia is recommended for your procedure. Ask what the side effects and risks of having anesthesia are in your case. Be sure to mention any medical problems you have, including allergies, and any medications you have been taking, since they may affect your response to the anesthesia.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.