COMPLICATIONS:

Complications which may result from the use of the LAP-BAND System include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body. Gastric banding that is done as a revision procedure has a greater risk of complication. The following are the complications reported in the published literature regarding the LAP-BAND System:

Peri-operative Complications:

Mortality

There are no moralities reported in the literature that are directly attributable to the use of the LAP-BAND System. The literature, however, does contain 5 reports of patients who have died in European countries as a result of complications occurring during or soon after surgery.

 

One patient died two days post-operatively as a result of pulmonary emboli (39). Another patient died of cardiogenic shock 10 hours after surgery (42) and a third is reported to have died three days after surgery due to sudden onset of gastroplegia with necrosis of the pouch without gastric perforation (43). A patient with Prader-Willi syndrome died 45 days after LAP-BAND System placement (35) and another patient died one week post-op from neuroleptic malignant syndrome following gastric perforation (44).

 

Stomach Perforation

The stomach may be perforated during surgery. Most surgeons report one or two stomach perforations, primarily during the learning curve period (30)(35)(36)(45)(46)(47), with gastric perforation rates ranging from 0.6% to 1.1% (35). If a perforation occurs at a distant location from the band, it may still be possible to repair the stomach laparoscopically and place the band successfully. Dr. Forestieri reported one gastric perforation (1.6%, n=62) during laparoscopic placement of the band during the retrogastric dissection. In this one case the gastric wall was repaired and the band successfully placed (48). Good surgical technique with adequate exposure and use of appropriate instruments can reduce the incidence of this serious complication (46).

 

Other Complications

Other complications are common to other forms of obesity surgery. Early postoperative complications of VBG, Gastric Bypass and Gastric Banding include wound infections, and wound dehiscence. However, surgeons report fewer peri-operative complications following LAP-BAND System placement than with other procedure (49).

Long-Term Complications:

Pouch Enlargement Associated with Stomach or Band Slippage

 

The LAP-BAND System literature contains reports of pouch enlargement usually associated with posterior slippage of the gastric wall in the unattached area of the bursa omentalis (36)(35)(30). The incidence of this complication has been dramatically reduced by one of these surgical methods; a posterior gastric stitch or the placement of the band above the bursa omentalis and through the phrenogastric ligament (20)(22)(35)(36)(50)(51)(52). In both methods the band is better secured, reducing the possibility of movement of the stomach through the band. Dr. Paul O’Brien (20) in a study of 302 patients with up to four years follow-up, has demonstrated a reduction in stomach slippage from 30% in his first 50 patients to 2.5% in his last 200 patients. Dr. O’Brien attributes the reduction in slippage rate to the introduction of posterior fixation of the band for those patients where the retrogastric passage was not through the retrogastric ligament but through the bursa omentalis. Dr. O’Brien noted that the clinical presentation of pouch enlargement occurred at a median of 8 (mean 8.5 months, range 2 days to 28 months) post-operatively.

 

Pouch Enlargement without Stomach or Band Slippage

 

 

There are rare reports of pouch enlargement (pouch dilatation) without stomach slippage (36)(35). When this type of pouch enlargement occurs it is attributed to the creation of an oversized pouch during surgery or early food intolerance (36). Creating a small (15mL) upper pouch has been demonstrated to be vital to the success of the surgery. There is a dramatic decrease in pouch enlargement problems when the initial pouch size is no more than 15mL in volume (34). In 1995 , Dr. Desaive published the results of a study comparing the effect of pouch size at surgery with later pouch dilatation. Two pouch sizes were compared; an initial 25mL pouch and an initial 15mL pouch. The re-operation rate for patients with the 25mL pouch was 33% while the re-operation rate for his first patients with the 15mL pouch dropped to 5.1% (53). Dr. Chelala (35) also experienced a reduction in pouch enlargement after changing his initial pouch size from 25mL to 15mL. The size of pouch and the dissection points for the retrogastric passage of the band can be more accurately determined with the use of the Calibration Balloon (46).

 

 

Pouch enlargement has been associated with early food intolerance (insufficient chewing of food, and overeating) which causes vomiting and stress on the new small pouch. In a series of 185 patients , Dr. Chelala noticed that excessive vomiting could lead to pouch dilatation. He also noted that overeating and sparkling drinks (carbonated drinks) may also cause vomiting and subsequent pouch enlargement. To address this situation, Dr. Chelala deflated the band, thus enlarging the stoma. He also decided to place his patients on a restrictive liquid diet in the early post-operative stage (35).

 

To reduce the incidence of early food intolerance, it is recommended that the LAP-BAND System stoma be initially kept large after surgery. A more open stoma may help accommodate any post-operative edema or patient difficulty in compliance while learning new eating habits.

Complications Associated with Pouch Enlargement and Band Slippage

An enlarged pouch caused by pouch dilatation or stomach/band slippage can lead to an obstruction of the stoma outlet and complete food intolerance in the patient. Again, accurate measurement of the initial pouch volume and correct positioning of the band through the retrogastric passage has reduced the incidence of these complications (46)(47).

Resolution of the Enlarged Pouch and or Slipped Band

A patient who is experiencing complications from pouch enlargement or band slippage is first treated by completely removing all saline from the inflatable band to enable the stoma to be as large as possible. The saline is extracted from the band by accessing the intra-muscularly placed access port with a special Huber tipped needle. This procedure is performed in an out-patient setting. In many cases the relaxed stoma allows the slipped stomach to move back to a position below the band. Dr. Alvarez-Cordero reports that out of 8 pouch dilatations, 3 were resolved through deflation of the band (54).

If deflating the band is not effective, there are several ways to laparoscopically treat stomach slippage. The slipped stomach can be reduced through the band, or the band can be opened and a new band placed through a new and higher (towards the esophagus) retrogastric dissection. The band can be removed and the stomach thus returned to its original form.

In many cases, the slipped or dilated stomach has been successfully reduced through an enlarged stoma and the corrective procedure has been completed laparoscopically (55). Dr Abu-Abeid was able to laparoscopically reposition 6 bands. He removed two at the patients’ request. He concluded "that band dislodgment may be treated safely and effectively using a laparoscopic technique" (55).

Erosion

Erosion of the band through the stomach tissue has been reported, resulting in removal of the band. Dr. Dargent reported a gastric erosion at 18 months post-op. The patient had regained weight but had no septic complication. The band was removed and a 2/3 gastrectomy performed (38).

An analysis of data representing 3,800 European subjects showed an erosion rate of 0.6% (36). Dr. Silecchia reported two band erosions at 6 and 8 months (5%) and removed the bands laparoscopically. Of the 40 patients in Silecchia’s study, 34% had had previous abdominal surgery, a situation which may cause the LAP-BAND System to erode if the band is placed over pre-existing sutures, staples or traumatized tissue (57).

Access Port and Tubing Related Complications

Migration or tipping of the access port, port or catheter leakage, as well as infection at the access port site, can occur and may require outpatient surgery to relocate, replace or remove the port. It is recommended that the access port be placed securely in the rectus sheath. This is achieved utilizing non-absorbable sutures in each of the access port’s four suture holes. Dr. Biesheuvel had an access port re-operation rate of 12% (n=87) and he noted that his first 36 patients had no reservoir fixation at the time of surgery ("fixation of the subcutaneous reservoir and higher placement of the band reduces the number of re-operations") (50).

Access ports may also become displaced from their original position as the patient loses weight. Access ports and tubing can be replaced surgically, normally in an outpatient setting using local anesthesia, when it is not possible to correct a problem through medical therapy.