Warnings, And Precautions

[kbattal 0]

Taken from

http://www.fda.gov/cdrh/pdf/P000008b.doc

WARNING: Laparoscopic or laparotomic placement of the LAP-BAND System is major surgery and death can occur

WARNING: Failure to secure the band properly may result in its subsequent displacement and necessitate reoperation.

WARNING: A large hiatal hernia may prevent accurate positioning of the device. Placement of the band should be considered on a case-by-case basis depending on the severity of the hernia.

WARNING: The band should not be sutured to the stomach. Suturing the band directly to the stomach may result in erosion.

WARNING: Patients’ emotional and psychological stability should be evaluated prior to surgery. Gastric banding may be determined to be inappropriate, in the opinion of the surgeon, for select patients.

WARNING: Patients should be advised that the LAP-BAND System is a long-term implant. Explant and replacement surgery may be indicated at any time. Medical management of adverse reactions may include explantation. Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.

WARNING: Esophageal distension or dilatation has been reported to result from stoma obstruction due to over-restriction, due to excessive band inflation. Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in small increments. Deflation of the band is recommended if esophageal dilatation develops.

WARNING: Some types of esophageal dysmotility may result in inadequate weight loss or may result in esophageal dilatation when the band is inflated and require removal of the band. On the basis of each patient's medical history and symptoms, surgeons should determine whether esophageal motility function studies are necessary. If these studies indicate that the patient has esophageal dysmotility, the increased risks associated with band placement must be considered.

WARNING: Patients with Barrett's esophagus may have problems associated with their esophageal pathology that could compromise their post-surgical course. Use of the band in these patients should be considered on the basis of each patient’s medical history and severity of symptoms.

WARNING: Patient self-adjustment of superficially placed access ports has been reported. This can result in inappropriate band tightness, infection and other complications.

Precautions

CAUTION: Laparoscopic band placement is an advanced laparoscopic procedure. Surgeons planning laparoscopic placement must:

Have extensive advanced laparoscopic experience, i.e., fundoplications.

Have previous experience in treating obese patients and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures.

Participate in a training program for the LAP-BAND System authorized by BioEnterics Corporation or an authorized BioEnterics distributor (this is a requirement for use).

Be observed by qualified personnel during their first band placements.

Have the equipment and experience necessary to complete the procedure via laparotomy, if required.

Be willing to report the results of their experience to further improve the surgical treatment of severe obesity.

CAUTION: It is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.

CAUTION: As with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract. Any damage to the stomach during the procedure may result in erosion of the device into the GI tract.

CAUTION: During insertion of the calibration tube, care must be taken to prevent perforation of the esophagus or stomach.

CAUTION: In revision procedures the existing staple line may need to be partially disrupted to avoid having a second point of obstruction below the band. As with any revision procedure, the possibility of complications such as erosion and infection is increased. Any damage to the stomach during the procedure may result in peritonitis and death, or in late erosion of the device into the GI tract.

CAUTION: Care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity, or subsequent surgery. Failure to do so may result in the inability to perform percutaneous band adjustments.

CAUTION: Care must be taken during band adjustment to avoid puncturing the tubing which connects the access port and band, as this will cause leakage and deflation of the inflatable section.

CAUTION: The LAP-BAND System is for single use only. Do not use a band, access port, needle or calibration tube which appears damaged (cut, torn, etc.) in any way. Do not use one of them if the package has been opened or damaged, or if there is any evidence of tampering. If packaging has been damaged, the product may not be sterile and may cause an infection.

Do not attempt to clean, re-sterilize or re-use any part of the LAP-BAND Adjustable Gastric Banding System. The product may be damaged or distorted if re-sterilized.

CAUTION: It is important that special care be used when handling the device because contaminants such as lint, fingerprints and talc may lead to a foreign body reaction.

CAUTION: Care must be taken to avoid damaging the band, its inflatable section or tubing, the access port or the calibration tube. Use only rubber-shod clamps to clamp tubing.

CAUTION: The band, access port and calibration tube may be damaged by sharp objects and manipulation with instruments. A damaged device must not be implanted. For this reason, a stand-by device should be available at the time of surgery.

CAUTION: Failure to use the tubing end plug during placement of the band may result in damage to the band tubing during band placement.

CAUTION: Do not push the tip of any instrument against the stomach wall or use excessive electrocautery. Stomach perforation or damage may result. Stomach perforation may result in peritonitis and death.

CAUTION: Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.

CAUTION: Failure to use an appropriate atraumatic instrument such as the LAP-BAND Closure Tool to lock the band may result in damage to the band or injury to surrounding tissues.

CAUTION: The band is not intended to be opened laparoscopically with surgical instruments. Unrecognized damage to the band may result in subsequent breakage or failure of the device.

CAUTION: When adjusting band volume take care to ensure that the radiographic screen is perpendicular to the needle shaft (the needle will appear as a dot on the screen). This will facilitate adjustment of needle position as needed while moving through the tissue to the port.

CAUTION: When adjusting band volume use of an inappropriate needle may cause access port leakage and require re-operation to replace the port. Use only LAP-BAND System Access Port Needles. Do not use standard hypodermic needles, as these may cause leaks.

CAUTION: When adjusting band volume never enter the access port with a “syringeless ” needle. The Fluid in the device is under pressure and will be released through the needle.

CAUTION: When adjusting band volume once the septum is punctured, do not tilt or rock the needle, as this may cause Fluid leakage or damage to the septum.

CAUTION: When adjusting band volume if fluid has been added to decrease the stoma size, it is important to establish, before discharge, that the stoma is not too small. Care must be taken during band adjustments not to add too much saline, thereby closing the gastric stoma. Check the adjustment by having the patient drink Water. If the patient is unable to swallow, remove some fluid from the port, then recheck. A physician familiar with the adjustment procedure must be available for several days post-adjustment to deflate the band in case of an obstruction.

CAUTION: It is the responsibility of the surgeon to advise the patient of the dietary restrictions which follow this procedure and to provide diet and behavior modification support. Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.

CAUTION: Patients must be carefully counseled on the need for proper dietary habits. They should be evaluated for nutritional (including caloric) needs and advised on the proper diet selection. If necessary to avoid any nutritional deficiencies, the physician may choose to prescribe appropriate dietary supplements. The appropriate physical monitoring and dietary counseling should take place regularly.

CAUTION: Patients must be cautioned to chew their food thoroughly. Patients with dentures must be cautioned to be particularly careful to cut their food into small pieces. Failure to follow these precautions may result in vomiting, stomal irritation and edema, possibly even obstruction.

CAUTION: Patients must be seen regularly during periods of rapid weight loss for signs of malnutrition, anemia or other related complications.

CAUTION: Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution. The use of such medications may be associated with an increased risk of erosion.

CAUTION: Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands.

CAUTION: All patients should have their reproductive areas shielded during radiography.

CAUTION: Insufficient weight loss may be caused by pouch enlargement or more infrequently band erosion, in which case further inflation of the band would not be appropriate.

CAUTION: Elevated homocysteine levels have been found in patients actively losing weight after obesity surgery. Supplemental folate and Vitamin B12 may be necessary to maintain normal homocysteine levels. Elevated homocysteine levels may increase cardiovascular risk and the risk of neural tube abnormalities.

CAUTION: Although there have been no reports of autoimmune disease with the use of the LAP-BAND System autoimmune diseases, connective tissue disorders (i.e., systemic lupus erythematosus, scleroderma) have been reported following long-term implantation of other silicone devices. These conditions have primarily been hypothesized to be associated with silicone breast implants. There is currently no conclusive clinical evidence to substantiate a relationship between connective-tissue disorders and silicone implants. Definitive long-term epidemiological studies to further evaluate this possible association are currently underway. However, the surgeon should be aware that if autoimmune symptoms develop following implantation, definitive treatment and/or band removal may be indicated. Likewise, patients who exhibit preexisting autoimmune symptoms should be carefully evaluated prior to implantation of the LAP-BAND System and may not be appropriate candidates (see Contraindications).

[enterprise01 0]

I found this same publication a couple of weeks ago and am puzzled by a couple of the warnings.

Taken from

http://www.fda.gov/cdrh/pdf/P000008b.doc

WARNING: The band should not be sutured to the stomach. Suturing the band directly to the stomach may result in erosion.

CAUTION: Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution. The use of such medications may be associated with an increased risk of erosion.

Isn't the lower stomach sutured to the band to help prevent slippage?

Many docs prescribe ibuprofen based pain-killers for post-op care, so are NSAIDs really that bad for the band?

[ousooner 1]

I am confused, you are reckless enough to give YOURSELF a fill, then you post this message to scare people. If your so concerned about safety, your previous actions make no sense.

[Jachut 487]

Your point being?

I'd say number one precaution is dont mess around with your own band!

[juno610 1]

Many docs prescribe ibuprofen based pain-killers for post-op care, so are NSAIDs really that bad for the band?

It's not that they are bad for the band, it's just that they can irritate the stomach, and that is something you would want to avoid. I've been told something along the lines of the medicines sitting in your stomach ABOVE the band and irritating that part of it before it moves through the stoma to be mixed with stomach acids and such. Hope that makes sense.

[thatgirl 0]

what's this for? I read all of this at my surgeon's....

[Chickie 15]

Precautions are only useful if you intend to heed them.

[Wheetsin 714]

NSAIDS can "ulcerate" tissues if they have prolonged contact. It's not the taking them that's bad, it's the "just sitting there" that restriction encourages. Can they really cause a problem? Absolutely. Then why did your surgeon prescribe them? Good question. Maybe it's one of those subjective things where some people think it's bad and others don't seem that phased by it. But in my personal life, I lost someone close to me because of complications around the tissue erosion that NSAIDS can cause... so I take all advice around them with extreme interest and seriousness.

[lisah25 3]

So, I have a question for the women here. I take Advil for cramps for a day or two every month. Now I'm wondering if I need to look for something else? In 30 years of having periods, nothing else worked, Tylonal, asprin, nothing. Anyone have a suggestion?

[Wheetsin 714]

Lisa - if it were me, I personally would not take them. It pained me greatly to give up my Aleve. :phanvan But ask your surgeon their opinion, or your PCP. I certainly don't want my experience to scare anyone, it's just made me extra cautious.

Have you tried the liquid Tylenol? Tylenol never did squat for me, except Tylenol sinus... but I had to take 3 or 4 of them. Since banding I"ve been faithful to liquid Tylenol and for me, it really works. WAY better than the pills ever did. And it's much faster, to boot.

[enterprise01 0]

I think my doc normally prescribes liquid Lortab, but in my case, he prescribed Darvocet (ibuprofen with a little codeine) because Lortab has caused me to vomit in the past. He did say to crush the Darvocet or cut it into small pieces before taking it. The problem with it "just sitting there" above the band makes sense. His nurse also told me I could take liquid Motrin if the codeine in the Darvocet bothered me. I plan on using the liquid Motrin for my next round of menstrual cramps.

[lisah25 3]

Lisa - if it were me, I personally would not take them. It pained me greatly to give up my Aleve. :phanvan But ask your surgeon their opinion, or your PCP. I certainly don't want my experience to scare anyone, it's just made me extra cautious.

Have you tried the liquid Tylenol? Tylenol never did squat for me, except Tylenol sinus... but I had to take 3 or 4 of them. Since banding I"ve been faithful to liquid Tylenol and for me, it really works. WAY better than the pills ever did. And it's much faster, to boot.

I've got a fill appointment on Feb 5th, and won't need any before then, so I think I'll ask while I'm there. I'm scared of eroding, but man the cramps are bad. My mom kept telling my I'd grow out of them. I didn't realize she meant when I hit menopause...:faint:

[lisah25 3]

I think my doc normally prescribes liquid Lortab, but in my case, he prescribed Darvocet (ibuprofen with a little codeine) because Lortab has caused me to vomit in the past. He did say to crush the Darvocet or cut it into small pieces before taking it. The problem with it "just sitting there" above the band makes sense. His nurse also told me I could take liquid Motrin if the codeine in the Darvocet bothered me. I plan on using the liquid Motrin for my next round of menstrual cramps.

That's a good idea!

[Wheetsin 714]

Oy yes. I have Mittelschmerz, which is a crazy German diagnosis for "it hurts like hell when I ovulate." When it really strikes there's nothing that can be done other than a fetal position. Fortunately it's only that bad once or twice every few years. I relied on Advil to get me through the rest. And Enterprise just reminded me of something. My surgeon did prescribe Lortab for post-op, but I didn't use even half of it, and I have taken it when I've had significant pain (e.g. gallbladder acting up) and it has done wonders.

You think I could have thrown in a paragraph break somewhere?

Poiint being that I have now completely forgotten my point. I guess the memories of mittelschmerz and post-op bliss blew my lobes way out of synch. *sigh*

[Shannon Craft 0]

I was just banded on Jan 26th... My docotor said only to take Tylenol products for pain...