viernes, 8 de febrero de 2013

Gastric Banding

Gastric banding is a surgical procedure to reduce the size of the stomach for weight loss. In this procedure, a silicone band is placed around the upper portion of the stomach to create a small pouch. Afterwards, the stomach is smaller, so people feel full faster, eat less and lose weight.

A gastric band is intended to be a long-term implant. Most people lose weight with the gastric band but one should not assume that a gastric band is a permanent device. A good number of people require another operation to reposition, replace or remove the gastric band sometime during their life due to complications or because they have not lost weight.

However, if you have any complications or you do not lose weight you may need to have additional surgery to reposition, replace or remove the gastric band.

The FDA has approved two gastric banding devices:

Lap-Band by Allergan, Inc. and
Realize Adjustable Gastric Band by Ethicon Endo-Surgery, Inc.

Patient Eligibility

Gastric banding is a weight loss option for people who have not been successful using non-surgical weight loss methods, such as supervised diet, exercise or behavior modification.

Both FDA-approved gastric banding devices are approved for patients who are 18 and older. The FDA has not approved any gastric band for use in patients under 18., because the agency has not reviewed the safety and effectiveness of gastric bands in patients of this age.

The FDA approved Allergan’s Lap-Band for use in obese patients with a Body Mass Index (BMI) of at least 40. It is also approved for patients with a BMI of 30-40 with one or more obesity-related (comorbid) conditions, such as high blood pressure, heart disease, diabetes or sleep apnea.

The FDA approved Ethicon’s Realize Adjustable Gastric Band for patients who are morbidly obese, with a BMI of at least 40. It is also approved for patients with a BMI of at least 35 with one or more related (comorbid) conditions.

People with certain stomach or intestinal disorders, who must take aspirin frequently or are addicted to alcohol or drugs should not have gastric banding.

Gastric banding requires a lifelong commitment to eating less and following doctor recommendations. People who are not able to do this may experience severe complications.

Surgical Procedure

Before deciding to have gastric banding surgery, you should discuss your medical conditions and any medications you are currently taking with your surgeon. You should also read the patient labeling, which provides information about the risks. If your surgeon does not provide you with a copy of the patient labeling, ask for it. If you have any questions, make sure to ask your surgeon before you agree to the procedure.

Gastric banding is usually performed using laparoscopic surgery. The surgery is performed while the patient is asleep (general anesthesia). The surgeon makes one to five small cuts (incisions) in the abdomen. A small camera and surgical instruments are placed through the cuts into the abdominal cavity.

During the surgery, the surgeon places an adjustable silicone band around the upper part of the stomach to create a small pouch. The band is connected with tubing to a port near the skin. Later, this port can be used to adjust the band without surgery. Once everything is in place, the camera and surgical instruments are removed and the cuts are closed with stitches.

The surgery usually takes about an hour to complete. Patients are usually sent home the same day as the procedure and are able to return to their normal activities, including returning to work, a few days later.

Following surgery, the doctor can adjust the band, without surgery, by adding or removing fluid through the implanted port. These adjustments tighten or loosen the band, allowing less or more or food to fit in the stomach.

Risks of Gastric Banding

It is important that you know and understand all the risks with gastric banding before deciding to have the procedure. Advertisements for a device or procedure may not include all of the risks, so it is important for you to read the patient labeling and talk to your doctor.

Any surgery involves risks, including death. There are risks from the surgical procedure and the medications or anesthesia used during surgery. Risks from surgery are greater when a patient is obese or has other serious health conditions.

In addition to the risks of surgery, you could experience any of the following complications after gastric banding surgery:

Nausea
vomiting or spitting-up food you just ate
difficulty swallowing
gastroesophageal reflux disease (GERD)
indigestion or upset stomach
abdominal pain
leaking of the gastric band
stretching of the new stomach pouch, so it no longer restricts the amount of food you can eat
moving of the gastric band from its original position, requiring another surgery to reposition it
erosion of the band through the stomach wall, and into the stomach, requiring additional surgery
stretching of the esophagus.

If you experience any of these complications, you should talk to your doctor right away. Some complications may lead to more operations or removal of the device.

Lifestyle Changes after Gastric Banding Surgery

Gastric banding is not a “quick fix.”

In order to be successful you must make major, long-term changes to your eating habits. The smaller pouch that is created at the top of your stomach will only be able to hold about a quarter cup of food at a time. If you eat too much, you may have complications such as nausea and vomiting.

For the first month or two after surgery you will be able to eat very little and will have to slowly add foods to your diet. Your surgeon and/or dietician will work with you to:

make smart food choices
teach you about changing how you chew and swallow your food
advise you on what foods to avoid
help you recognize when you are full
increase your physical activity

In addition to making changes to your diet, you will need to make regular follow-up visits to your doctor to monitor your progress and make any adjustments to your band.

It is important to remember that each person will have an individual experience. You may not lose weight or be able to keep lost weight off.

Warning Letters

The FDA issued warning letters to several California-based surgical centers and a marketing company for failing to include appropriate use and risk information, such as warnings, precautions, side effects, and contraindications that are required in advertising certain devices.