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 LAP-BAND AP® Adjustable Gastric Banding System with Rapid Port® EZ and Omniform™ Design

DESCRIPTION Ref. No. C-2360

LAP-BAND AP® System Standard w/RapidPort® EZ

Ref. No. C-2365

LAP-BAND AP® System Large w/RapidPort® EZ

The LAP-BAND AP® Adjustable Gastric Banding System is designed to induce weight loss in severely obese patients by limiting food consumption. The band’s slip-through buckle design makes laparoscopic placement around the stomach easier, allowing the formation of a small gastric pouch and stoma. No cutting or stapling of the stomach is required, and there is no bypassing of portions of the stomach or intestines.

The LAP-BAND AP® Adjustable Gastric Banding System with OMNIFORM™ Design is the latest advance in laparoscopic adjustable gastric banding for the treatment of morbid obesity. The initial pouch and stoma sizes are established through the use of the calibration tube. The inner surface of the band is inflatable and connected by kink-resistant tubing to the Access Port, which is included in the LAP-BAND AP® System. This permits post-operative percutaneous, stoma size adjustment. Dietary and behavior modification counseling and frequent, long-term follow-up are required for all patients after weight- loss surgery.

Surgeons planning laparoscopic placement must have extensive advanced laparoscopic experience, i.e., fundoplications as well as previous experience in treating obese patients, and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures. They should comply with the American Society for Metabolic & Bariatric Surgeons (ASMBS) and the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) joint “Guidelines for Surgical Treatment of Morbid Obesity” and the SAGES “Guidelines for Framework for Post-Residency Surgical Education and Training”. Surgeon participation in a training program authorized by ReShape Lifesciences, Inc. or by an authorized ReShape Lifesciences, Inc. distributor is required prior to use of the LAP-BAND AP® System. Please see the last page for directions on obtaining additional information.

Brief Description of Procedure

During the surgical procedure, the inflatable band is flushed with sterile saline. The band is placed around the stomach and inflated with sterile saline to create the proper stoma diameter and pouch size using the calibration tube. The tubing is connected to the Access Port placed on the rectus muscle or fixed in an accessible subcutaneous space. Arrows pointing in the direction of the Access Port are printed on the tubing.  These arrows assist the surgeon in identifying the correct tubing orientation. The tubing may be shortened to tailor the position of the port to the patient. The two components (tubing and Access Port) are joined with the stainless steel tubing connector. Ligatures may be placed on both tubing ends over the connector. The Access Port may then be secured in place utilizing the suture holes in the port base, stainless steel anchors using the RapidPort® EZ Applier Tool, or other fixation methods. Postoperatively, the surgeon may adjust the stoma size percutaneously by injecting or aspirating saline with the Access Port needle.

Please refer to the Surgical Procedure section for more information.

INTENDED USE / INDICATIONS

The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

CONTRAINDICATIONS

The LAP-BAND AP® System is contraindicated in:

  1. Patients with inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn’s disease.
  2. Patients with severe cardiopulmonary diseases or other serious organic disease which may make them poor surgical candidates.
  3. Patients with potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices or congenital or acquired intestinal telangiectases.
  4. Patients with portal hypertension.
  5. Patients with congenital or acquired anomalies of the GI tract such as atresias or stenoses.
  6. Patients who have/experience an intra-operative gastric injury during the implantation procedure, such as a gastric perforation at or near the location of the intended band placement.
  7. Patients with cirrhosis.
  8. Patients with chronic pancreatitis.
  9. Patients who are addicted to alcohol and/or drugs.
  10. Non-adult patients (patients under 18 years of age).
  11. Patients who have an infection anywhere in their body or where the possibility of contamination prior to or during the surgery exists.
  12. Patients on chronic, long-term steroid treatment.
  13. Patients who are unable or unwilling to comply with dietary restrictions that are required by this procedure.
  14. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system or who have exhibited pain intolerance to implanted devices.
  15. Patients or family members with a known diagnosis or pre-existing symptoms of autoimmune connective-tissue disease such as systemic lupus erythematosus or scleroderma.
  16. Pregnancy: Placement of the LAP-BAND AP® System is contraindicated for patients who currently are or may be pregnant. Patients who become pregnant after band placement may require deflation of their bands.

WARNINGS

  1. Laparoscopic or laparotomic placement of the LAP-BAND AP® System is major surgery and death can occur.
  2. Failure to secure the band properly may result in its subsequent displacement and necessitate a second operation.
  3. 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.
  4. The band should not be sutured to the stomach. Suturing the band directly to the stomach may result in erosion.
  5. Patients’ emotional and psychological stability should be evaluated prior to surgery. Gastric banding may be determined by physician to be inappropriate for select patients.
  6. Patients should be advised that the LAP-BAND AP® System is a long-term implant. Explant (removal) 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.
  7. Esophageal distension or dilatation has been reported to result from stoma obstruction from over-restriction by 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.
  8. Some types of esophageal dysmotility may result in inadequate weight loss or may result in esophageal dilatation when the band is inflated and may 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.
  9. 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.
  10. Patient self-adjustment of superficially placed access ports has been reported. This can result in inappropriate band tightness, infection and other complications.
  11. Cases of device erosion into the stomach as well as extra-gastric organs and tissues such as the colon (with gastro-colic fistula) and the aorta (with pseudoaneurysm and/or fistula formation) have been reported. These may result in serious injury with the need for prompt surgical intervention or death.
  12. Cases of gastric and colonic volvulus as well as small bowel entanglement and obstruction have been reported with device use. These may occur in association with band migration, slippage or twisting with/around the tubing. Such events may result in ischemia, organ necrosis, and further tissue damage, including infection and perforation. These events should be considered in implanted patients presenting with signs or symptoms of obstruction or an acute abdomen. Immediate intervention may be required.

PRECAUTIONS

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

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

    b. 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.

    c. Participate in a training program for the LAP-BAND® System authorized by ReShape Lifesciences, Inc. or an authorized ReShape Lifesciences, Inc. distributor (this is a requirement).

    d. Be observed by qualified personnel during their first band placements.

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

    f. Be willing to report the results of their experience to further improve the surgical treatment of severe obesity.
  2. It is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.
  3. As with 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.
  4. During insertion of the calibration tube, care must be taken to prevent perforation of the esophagus or stomach.
  5. Revision procedures may require the existing staple line 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.
  6. 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.
  7. Care must be taken during band adjustment to avoid puncturing the tubing that connects the Access Port and band, as this will cause leakage and deflation of the inflatable section.
  8. Failure to create a stable, smooth path for the Access Port tubing, without sharp turns or bends, can result in tubing breaks and leakage. In order to avoid incorrect placement, the port should be placed lateral to the trocar opening. A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing. The tubing path should point in the direction of the Access Port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen. (See Figure 1. Port Placement Options).
Port Placement Options

 Figure 1. Port Placement Options

  1. The LAP-BAND AP® System is for single use only. Do not use a band, Access Port, needle or calibration tube that appears damaged (cut, torn, etc.) in any way. Do not use any of the above components 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.
  2. Do not attempt to clean or re-sterilize any part of the LAP-BAND AP® System. The product may be damaged or distorted if re-sterilized.
  3. Special care must be used when handling the device because contaminants such as lint, fingerprints and talc may lead to a foreign body reaction.
  4. 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.
  5. 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.
  6. Failure to use the tubing end plug during placement of the band may result in damage to the band tubing during band placement.
  7. Do not push the tip of any instrument against the stomach wall or use excessive electrocautery. Stomach perforation or damage may result in peritonitis and death.
  8. Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.
  9. Failure to use an appropriate atraumatic instrument to lock the band may result in damage to the band or injury to surrounding tissues.
  10. When adjusting band volume, take care to ensure 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.
  11. When adjusting band volume, use of an inappropriate needle may cause Access Port leakage and require reoperation to replace the port. Use only LAP-BAND AP® System Access Port Needles. Do not use standard hypodermic needles, as these may cause leaks.
  12. When adjusting band volume, the needle must be inserted perpendicular to the Access Port septum. Failure to do so may cause damage to the port and result in leaks.
  13. 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.
  14. When adjusting band volume after the septum is punctured, do not tilt or rock the needle, as this may cause fluid leakage or damage to the septum.
  15. If fluid has been added, it is important to establish that the stoma is not too small before discharge. Care must be taken to not 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 re-check. A physician familiar with the adjustment procedure must be available for several days post-adjustment to deflate the band in case of an obstruction.
  16. It is the responsibility of the surgeon to advise the patient of the dietary restrictions that 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.
  17. 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. The physician may choose to prescribe appropriate dietary supplements. Appropriate physical monitoring and dietary counseling should take place regularly.
  18. 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.
  19. Patients must be seen regularly during periods of rapid weight loss for signs of malnutrition, anemia or other related complications.
  20. Anti-inflammatory agents, such as aspirin and non- steroidal anti-inflammatory drugs (NSAIDs), may irritate the stomach and should be used with caution. The use  of such medications may be associated with an increased risk of erosion.
  21. Patients who become pregnant, severely ill, or who require more extensive nutrition may require deflation of their bands.
  22. All patients should have their reproductive areas shielded during radiography.
  23. 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.
  24. 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.
  25. Although there have been no reports of autoimmune disease with the use of the LAP-BAND® System, auto-immune diseases/connective tissue disorders (i.e., systemic lupus erythematosus, sclero-derma) have been reported following long-term implantation of other silicone implants. However, there is no conclusive evidence to substantiate a relationship between connective-tissue disorders and silicone implants.

ADVERSE EVENTS

It is important to discuss all possible complications and adverse events with your patient. Complications which may result from the use of this product 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.

Perforation of the stomach can occur. Death can also occur. Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.

Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.

Band slippage and/or pouch dilatation can occur. Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases. More serious slippages may require surgery to reposition and/or remove the band. Immediate reoperation to remove the band is indicated if there is total stoma outlet obstruction that does not respond to band deflation or if there is abdominal pain.

Gastric banding done as a revision procedure has a greater risk of complications. Prior abdominal surgery is commonly associated with adhesions involving the stomach. In the US pivotal study of severely obese adults, 42% of the subjects undergoing revision surgery were reported to have adhesions involving the stomach. Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.

There is a risk of band erosion into stomach tissue. Erosion of the band into stomach tissue has been associated with revision surgery after the use of gastric-irritating medications, after stomach damage and after extensive dissection or use of electrocautery, and during early experience. Symptoms of band erosion may include reduced weight loss, weight gain, Access Port infection, or abdominal pain. Reoperation to remove the device is required.

Reoperation for band erosions may result in a gastrectomy of the affected area. Eroded bands have been removed gastroscopically in a very few cases. Consultation with other experienced LAP-BAND® System surgeons is strongly advised in these cases.

Esophageal distension or dilatation has been infrequently reported. This is most likely a consequence of incorrect band placement, over-restriction or stoma obstruction. It can also be due to excessive vomiting or patient noncompliance, and may be more likely in cases of pre-existing esophageal dysmotility. Deflation of the band is recommended if esophageal dilatation develops. A revision procedure may be necessary to reposition or remove the band if deflation does not resolve the dilatation.

Obstruction of stomas has been reported as both an early  and a late complication of this procedure. This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion, or patient non-compliance regarding choice and chewing of food.

Infection can occur in the immediate post-operative period or years after insertion of the device. In the presence of infection or contamination, removal of the device is indicated.

Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.

Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended. Nausea and vomiting may also be symptoms of stoma obstruction or a band/stomach slippage. Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation. Deflation of the band is immediately indicated in all of these situations. Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting. Reoperation to reposition or remove the device may be required.

Rapid weight loss may result in symptoms of malnutrition, anemia and related complications (i.e., polyneuropathies). Deflation of the band may alleviate excessively rapid weight loss.

Rapid weight loss may result in development of cholelithiasis which may require cholecystectomy.

Table 1 summarizes serious adverse events (SAEs) that were reported to have occurred during the 3-year US pivotal clinical trial in severely obese adults, initiated in 1995. A total of 299 subjects were studied with a total of 633 subject years.

TABLE 1: SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND® SYSTEM FOR THE US PIVOTAL STUDY IN SEVERELY OBESE ADULTS
Adverse Event% of 299 subjects
Band Slippage, Pouch Dilation11
Stoma Obstruction8
Gastroesophageal Reflux3
Esophageal Dilatation2
Cholelithiasis2
Incisional Infection2
Abdominal Pain2
Gastroenteritis2
Nausea and/or Vomiting2
Port Leak2
Delayed Esophageal Emptying1
GI Perforation1
Hernia1
Band Erosion1
Chest Pain1
Dysphagia1
Infection1
Asthma1
Atelectasis1
Dehydration1
Headache1
Abnormal Healing1
Hiatal Hernia1
Improper Band Placement1
Respiratory Disorder1
Thrombosis1
Thyroid Disorder1
Death0

There were additional occurrences of these events that were considered to be non-serious.

Table 2 shows occurrences of all adverse events reported at a rate of 5% or more.

TABLE 2: ALL ADVERSE EVENTS THAT OCCURRED AT A RATE OF 5% OR MORE FOR THE US PI VOTAL STUDY IN SEVERELY OBESE ADULTS
ADVERSE EVENT# of subjects% of 299 subjects
DIGESTIVE
Nausea and/or Vomiting15251
Gastroesophageal Reflux10334
Stoma Obstruction4114
Constipation279
Dysphagia269
Diarrhea227
Abnormal Stools186
BODY AS A WHOLE

Abdominal Pain8027
Asthenia258
Incisional Infection217
Infection207
Fever186
Hernia165
Pain165
Chest Pain155
Pain Incision145
BAND SPECIFIC
Band Slippage/ Pouch Dilation7224
METABOLIC AND NUTRITIONAL
Healing Abnormal238
PORT-SPECIFIC
Port Site Pain269
Port Displacement186
SKIN AND APPENDAGES
Alopecia238

Other adverse events considered related to the LAP-BAND® System that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, GI perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury, and wound infection.

Twenty-six subjects (9%, 26/299) had a total of 27 reoperations. Thirteen of these 27 (48%) revision procedures were completed laparoscopically. In 9 of the 27 procedures (33%), the band was removed and replaced with a new band in the same procedure. These were due to: 3 initially incorrect placements, 5 stoma obstructions or band slippage/pouch dilatation, and 1 band system leakage. Two subjects had new band replacements at separate interventions. Sixteen of 27 revision procedures (59%) did not require removal of bands. All of these revisions were performed to correct band slippage/pouch dilatation. Six of these (37.5%) were completed laparoscopically. There were no deaths associated with LAP-BAND® System revisions.

Seventy-five subjects had their entire LAP-BAND® Systems explanted. Fifty-one of the 75 explants (68%, 51/75) were counter measures to adverse events. Band slippage/pouch dilatation and/or stoma obstruction was the most common adverse event associated with these explants (32%, 24/75). Other events associated with these explants were erosion (5%, 4/75), infection (4%, 3/75), GI disorders such as gastroesophageal reflux and/or dysphagia (11%, 8/75),

LAP-BAND® System leak (4%, 3/75); one needle damage to shell and 2 access port tubing leaks, esophageal disorders, such as dilatation and delayed emptying (7%, 5/75); gastric perforation (3%. 2/75); one abdominal pain; and one respiratory disorder. Insufficient weight loss was also reported as a contributor to the decision to explant in 24 of the 75 explants (32%, 24/75). Data from a post-approval study showed an estimated explant rate of 6.5% per year over the first five years following implantation.

One-year data are available for 149 obese subjects with BMI ≥30 and <40 who underwent LAP-BAND® System placement surgery in a Lower BMI study, initiated in 2007. This study will continue to follow subjects for an additional 4 years (5 years in total). The following table summarizes the SAEs that were reported to have occurred in the US Lower BMI clinical trial.

TABLE 3: SERIOUS ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND® SYSTEM FOR THE US LOWER BMI STUDY
ADVERSE EVENT# of subjects% of 149 subjects
Abdominal Pain21.3
Shoulder pain10.7
Dysphagia10.7
Medical Device Complication (Band Erosion)10.7
Gastric Outlet Obstrucion10.7
Vomiting10.7

These seven device-related SAEs occurred in three subjects (2%, 3/149). They were hospitalized for 7 days or less and discharged following band removal. There were no deaths in the Lower BMI Study.

TABLE 4. DEVICE-RELATED ADVERSE EVENTS THAT OCCURRED IN ≥2% OF SUBJECTS IN THE US LOWER BMI STUDY

TABLE 4. DEVICE-RELATED ADVERSE
EVENTS THAT OCCURRED IN ≥2% OF SUBJECTS
IN THE US LOWER BMI STUDY

Adverse Event

Subjects

Events

Mild

Moderate

Severe

N

(%)a

N

(%)b

n (%)

n (%)

n (%)

Vomiting

43

(28.9%)

43

(20.0%)

29 (67.4%)

13 (30.2%)

1 (2.3%)

Dysphagia

33

(22.1%)

33

(15.3%)

20 (60.6%)

12 (36.4%)

1 (3.0%)

Post procedural pain

28

(18.8%)

28

(13.0%)

1 (3.6%)

27 (96.4%)

0 (0.0%)

Gastroesophageal reflux disease

22

(14.8%)

22

(10.2%)

15 (68.2%)

7 (31.8%)

0 (0.0%)

Abdominal pain

8

(5.4%)

8

(3.7%)

2 (25.0%)

6 (75.0%)

0 (0.0%)

Nausea

8

(5.4%)

8

(3.7%)

5 (62.5%)

3 (37.5%)

0 (0.0%)

Dyspepsia

7

(4.7%)

7

(3.3%)

4 (57.1%)

3 (42.9%)

0 (0.0%)

Implant Site Pain

7

(4.7%)

7

(3.3%)

6 (85.7%)

1 (14.3%)

0 (0.0%)

Abdominal pain upper

4

(2.7%)

4

(1.9%)

3 (75.0%)

1 (25.0%)

0 (0.0%)

Constipation

4

(2.7%)

4

(1.9%)

3 (75.0%)

1 (25.0%)

0 (0.0%)

Medical device complicationc

4

(2.7%)

4

(1.9%)

2 (50.0%)

1 (25.0%)

1 (25.0%)

Dehydration

3

(2.0%)

3

(1.4%)

1 (33.3%)

2 (66.7%)

0 (0.0%)

Device malfunctiond

3

(2.0%)

3

(1.4%)

0 (0.0%)

2 (66.7%)

1 (33.3%)

Shoulder pain

3

(2.0%)

3

(1.4%)

1 (33.3%)

2 (66.7%)

0 (0.0%)

ADVERSE EVENTSubjectsEventsMildModerateSevere
N(%)
a
N(%)
b
n
(%)
n
(%)
n
(%)
Vomiting43(28.9%)43(20.0%)29 (67.4%)13 (30.2%)1 (2.3%)
Dysphagia33(22.1%)33(15.3%)20 (60.6%)12 (36.4%)1 (3.0%)
Post procedural pain28(18.8%)28(13.0%)1 (3.6%)27 (96.4%)0 (0.0%)
Gastroesophageal reflux disease22(14.8%)22(10.2%)15 (68.2%)7 (31.8%)0 (0.0%)
Abdominal pain8(5.4%)8(3.7%)2 (25.0%)6 (75.0%)0 (0.0%)
Nausea8(5.4%)8(3.7%)5 (62.5%)3 (37.5%)0 (0.0%)
Dyspepsia7(4.7%)7(3.3%)4 (57.1%)3 (42.9%)0 (0.0%)
Implant Site Pain7(4.7%)7(3.3%)6 (85.7%)1 (14.3%)0 (0.0%)
Abdominal pain upper4(2.7%)4(1.9%)3 (75.0%)1 (25.0%)0 (0.0%)
Constipation4(2.7%)4(1.9%)3 (75.0%)1 (25.0%)0 (0.0%)
Medical device complicationc4(2.7%)4(1.9%)2 (50.0%)1 (25.0%)1 (25.0%)
Dehydration3(2.0%)3(1.4%)1 (33.3%)2 (66.7%)0 (0.0%)
Device malfunctiond3(2.0%)3(1.4%)0 (0.0%)2 (66.7%)1 (33.3%)
Shoulder pain3(2.0%)3(1.4%)1 (33.3%)2 (66.7%)0 (0.0%)

a Percentage is based on 149 subjects

b Percentage is based on 215 device-related adverse events

c Complications included band erosion, tubing palpated in umbilical hernia, and band slippage

d Malfunctions included partial slip, flipped port, and band slippage.

There were additional occurrences of these events that were considered to be non-serious. Table 4 shows occurrences of all device-related events reported at a rate of 2% or more.

Other adverse events considered related to the LAP-BAND® System that occurred in fewer than 2% of study patients included: diarrhea (n=2), gastric pouch dilatation (n=2), gastritis (n=2), esophageal dilatation (n=2), syncope (n=2), seroma (n=2). Other events reported to occur in only one patient per event included; abdominal discomfort, alopecia, anemia, arthralgia, decrease blood folate, flatulence, gastrointestinal motility disorder, bronchitis, chills, implant site infection, implant site irritation, implant site hemorrhage, night sweats, hypotrichosis, headache, nail infection, pyrexia, skin irritation, esophageal obstruction, esophageal spasm, postoperative infection, urinary tract infection, muscle spasms, depression, back pain, and hypertension.

Seven subjects (4.6%, 7/149) each required one reoperation, and there were no intraoperative complications. Four of these (57.1%, 4/7) were LAP-BAND® System explantations due to dysphagia (in 2 subjects), erosion of the band, or abdominal pain.  Two reoperations were access port revisions due to  port flip or port site pain; the original ports were retained. One reoperation was for repositioning of the original band to correct for band slippage.

Global product experience obtained through complaint and adverse event reporting during the course of real-world clinical use provides valuable insight into the safety profile of the LAP-BAND device. As of July 31, 2017 more than 1,048,000 devices have been distributed to countries with LAP-BAND approval. No regulatory approvals have been revoked or withdrawn. The ReShape Lifesciences, Inc. complaint database houses vigilance reports for adverse events submitted to various competent authorities by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals and patients. Device- and procedure-related adverse events or complaints reported through clinical product surveillance and literature reviews are contained within this data. A total of 10,970 complaints spanning a period from January 1, 2008 to July 31, 2017 are presented in Table 5; however, this data has not been scientifically validated and may include duplication of some events due to multiple sources of data collection. Some events have not been directly attributed to LAP-BAND®.

Table 5. LAP-BAND® device- and procedure- related adverse events and complaints reported through clinical product surveillance1 between January 1, 2008 and July 31, 2017.

Events1Count2Rate3
Abscess500.005%
Adhesion290.003%
Allergic Reaction100.001%
Aneurism (Band Aneurism)370.004%
Band Erosion40.000%
Band Restriction Issue540.005%
Band Slippage9170.087%
Bowel Complications160.002%
Broken / Damaged / Defective Component
3

0.000%
Broken Device190.002%
Buckle Disengagement / Band Disengagement
43

0.004%
Cancer20.000%
Cardiac Complication50.000%
Cardio-Pulmonary Arrest80.001%
Cellulitis90.001%
Cholelithiasis100.001%
Connective Tissue / Autoimmune Disorders
7

0.001%
Cough90.001%
Damaged Port Tubing10.000%
Death420.004%
Dehydration460.004%
Depression40.000%
Device Appearance – Post Operative
3

0.000%
Difficulty Adding/Removing Saline950.009%
Displacement / Port Displacement2490.024%
Drainage350.003%
Dysphagia3230.031%
Dyspnea230.002%
End User Error20.000%
Erosion4610.044%
Erosion/Ulceration20.000%
Esophageal Dilatation650.006%
Esophageal Dysmotility60.001%
Esophageal Perforation140.001%
Extrusion120.001%
Fever150.001%
Fistula240.002%
Fold In Tubing230.002%
Gastric Erosion360.003%
Hematoma130.001%
Hemorrhage470.004%
Hernia1270.012%
Hypertrophic Scarring10.000%
Hyposensitivity/Hypersensitivity20.000%
Incorrect Placement30.000%
Infection4050.039%
Intolerance1990.019%
Irritation/Inflammation1750.017%
Ischemia20.000%
Leak(s) or Leakage – Band, Port, Port Base, Port Tubing, Port Septum and Access Port Leakages4

3,887


0.371%
Malaise100.001%
Multiple Symptoms70.001%
Myocardial Infarction30.000%
Nausea1880.018%
Necrosis250.002%
Obstruction2180.021%
Other2730.026%
Pain57960.076%
Pancreatitis20.000%
Port Erosion10.000%
Port Tubing Disconnection / Disengagement
10

0.001%
Pouch Dilation2160.021%
Product Material Anxiety10.000%
Pulmonary Embolism140.001%
Reflux4740.045%
Respiratory Disorder30.000%
Seroma160.002%
Skin Erosion20.000%
Stomach Perforation / Erosion590.006%
Surgery Related Observation / Complication
140

0.013%
Symptoms of Autoimmune / Connective Tissue Disorders
3

0.000%
Thrombus30.000%
Ulcer200.002%
Unsatisfactory Weight Loss3200.031%
Varied Injuries470.004%
Vessel Damage / Bleeding40.000%
Visibility/Palpability360.003%
Vomiting4900.047%
Wound Dehiscence150.001%
Total10,9701.046%
  1. This data has not been scientifically validated and may include duplication of some events due to multiple sources of data collection. Some events have not been directly attributed to LAP-BAND®.
  2. Some complaints were counted more than once within a category due to multiple events reported. Above numbers do not indicate number of devices nor patients involved. 
  3. The event rate represents the counts of an event divided by the number of devices distributed (1,048,262) as of the reporting cut-off on July 31, 2017.
  4. This category includes reports of ‘band leaks’ and ‘port leaks’.
  5. This category includes ‘abdominal pain’, ‘chest pain’, ‘back pain’, ‘discomfort’, and ‘headache’.

CLINICAL EXPERIENCE

The LAP-BAND® System is indicated for use only in patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

The effects of the LAP-BAND® System have been studied in severely obese subjects (BMI ≥ 40 or those who are 100 lbs. or more over their estimated ideal weight) as well as in mild to moderately obese subjects (BMI ≥30 and <40) in the US, in the pivotal study and Lower BMI study, respectively.

Clinical Experience in Severely Obese Adults (initiated in 1995)

Purpose of the Trial:

This study evaluated the safety and effectiveness of the device for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40, or those who are 100 lbs. or more over their estimated ideal weight, as determined using the 1983 Metropolitan Life Insurance Height and Weight Table (using the midpoint for medium frame).

Study Design:

A 3-year, single-arm, multi-center study was initiated in June 1995 with 299 subjects enrolled at 8 centers under the care of 12 surgeons. All procedures were completed utilizing aperigastric dissection technique with pouches of 25 ml or (later in the study) 15 ml, using the 9.75cm (B-2210) and 10.0cm (B-2220) LAP-BAND® Systems. Of the procedures, 259 were completed laparoscopically and 33 via laparotomy, including 13 intraoperative conversions (4.7% conversion rate).

The primary effectiveness measure was the percent Excess Weight Loss (%EWL) at 1, 2, and 3 years following the LAP-BAND® implantation. The secondary effectiveness measures used in the study determined the differences between the weight loss (at years 1, 2 and 3) and the weight loss/gain experienced by the subject in the years(s) prior to the placement of the LAP-BAND® System. In addition, changes in a subject’s quality of life were also determined as part of the secondary effectiveness measure.

The %EWL is defined as weight loss (operative weight minus selected weight) divided by excess weight (operative weight minus ideal weight) multiplied by 100. Study subjects were weighed immediately before surgery, at 3 weeks postoperatively, and then again at regular intervals over the next 3 years (3, 6, 9, 12, 18, 24, 30, and 36 months). The 1983 Metropolitan Life Height and Weight Table was used to determine ideal weight.

The primary safety parameters included incidence and severity of complications. Safety measurements were based on subjects’ reported adverse events before surgery (< 3 weeks) and postoperatively (> 3 weeks), either during scheduled visits or as called to the attention of the study nurse or investigator to report urgent problems. Any noted complications were divided into device-related and non- device-related events.

Subjects Studied:

A total of 299 subjects participated in the U.S. study, with 85% of participants being female and 15% being male. Distribution by race was 81% Caucasian, 15% African-American and 4% Hispanic. The average age at which subjects became obese was 18.4 and the average age at the time of surgery was 38.8 years.

The mean weight at entry into the trial was 293 pounds, with mean excess weight of 156 pounds and mean BMI of 47.4. Thirty percent (30%) of subjects had BMI ≥ 50 and were classified as “superobese.” During the five years prior to surgery, subjects on average gained 54 pounds, with the average BMI increasing from 39 to 47.4. These subjects had significant comorbidities which included: hypertension (42%), gallstone/gallbladder disease (25%), gastrointestinal diseases (24%), asthma (16%), non-insulin dependent diabetes (11%), and insulin dependent diabetes (5%).

Subject Inclusion Criteria:

  • Age 18 to 55.
  • BMI ≥ 40, or at least 100 pounds above estimated ideal weight.
  • Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  • History of obesity for at least 5 years.

04-0723 Rev. A