January 2014

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

In 2007, LF Martin et al. published a paper in American Journal of Surgery titled “Treating morbid obesity with laparoscopic adjustable gastric banding.”.  This paper aimed to evaluate the safety and efficacy of laparoscopic adjustable gastric banding for weight loss in obese patients.

For this study, Martin et al. (2007) “reviewed 2 multicenter prospective, open-label, single-arm surgical trials–trial A (3 years) and trial B (1 year)–with ongoing safety follow-up.”  The first trial included 292 patients, and the second included 193 patients.  Researchers write that about 70% and and 73% of the patients completed the 3- and 1-year follow-up periods, respectively.

While this team found gastric banding to be effective in weight loss, there were a high number of complications observed.  “The percentage of initial body weight lost at 1 year was 17.7% +/- 9.4% for trial A subjects and 18.2% +/- 8.9% for trial B subjects, whereas the 3-year total for trial A subjects was 18.3% +/- 13.1%.”

Concerning complications, “At 1 year, 76% of patients in trial A and 66% of patients in trial B had complications, mostly related to upper gastrointestinal symptoms. By 9 years after surgery, 33% (96 of 292) of trial A subjects had their devices explanted because of complications or inadequate weight loss.”

Since these complication and explantation rates are so much higher than those reported in the Allergan LAP-BAND gastric banding system warning label, a great number of LAP-BAND lawsuits are currently being filed.

 

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

In a 2002 paper by FD Capizzi et al. titled “Laparoscopic adjustable esophagogastric banding: preliminary results.” published in Obesity Surgery, it is written “Laparoscopic gastric banding is effective in surgical treatment of morbid obesity, but has had the drawback of specific complications, like slippage and gastric erosion. To prevent such complications, modifications have been used, including high retrogastric positioning above the bursa omentalis, complete anterior fixation by gastro-gastric stitches over the band, and reduction of the pouch volume to < or = 15 ml” and “These technical variants may induce dysphagia.”

To study the safety and efficacy of this LAP-BAND technique, Capizzi et al. (2002) reviewed 80 consecutive patients who had undergone laparoscopic adjustable esophagogastric banding between January 1999 and March 2001 at an Italian hospital.

Concerning efficacy, doctors found that “Mean BMI decreased from 45 to 38 after 6 months, remaining at 37 after 24 months, while excess weight was reduced by 50% at 24 months.”

“Complications included 2 cases of slippage: an early one after 24 h, requiring surgical removal, and a late one after 9 months, treated by laparoscopic repositioning. The third complication, a reactive esophageal stenosis, occurred in a transsexual male on estrogen treatment, that needed replacement with a wider Swedish band.”  It is also stated that “Band adjustment was required in 28 patients, one time in 22 cases and twice in the other 6”, representing a 35% reoperation rate.

Due to the fact that reoperations rates such as this have been determined by independent researchers to be significantly higher than those reported in the LAP-BAND Warning Label, a number of LAP-BAND lawsuits have been filed.

 

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

A paper published in the November, 2005 edition of Surgery titled “Obese teenagers treated by Lap-Band System: the Italian experience.” lived up to its name and evaluated “results of laparoscopic adjustable gastric banding in obese teenagers” chosen from “the database of the Italian Collaborative Study Group for Lap-Band”, identifying 58 patients.

The authors of this study, L. Angrisani et al., found that “Overall postoperative complications occurred in 6/58 (10.3%). The band was removed in 6/58 (10.3%) patients for gastric erosion (3 patients), psychologic, intolerance (2 patients), and in the remaining patient was converted 2 years after surgery (BMI 31) to gastric bypass or gastric pouch dilatation.”

At 1, 3, 5, and 7 years’ follow-up, percent excess weight loss was found to be 45.6%, 39.7%, 43.7%, and 55.6%, respectively (plus/minus standard deviation).

Though effective, these rates of complications are higher than those reported by the LAP-BAND manufacturer, Allergan.  As such, many LAP-BAND lawsuits were filed.

 

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

In a 2006 article titled “Quality of life after laparoscopic gastric banding: Prospective study (152 cases) with a follow-up of 2 years.” by A. Champault et al, published in Surgical Laparoscopy, Endoscopy & Percutaneous Techniques set out to determine the quality of life in patients who had used laparoscopic adjustable gastric banding systems for weight loss after two years.

Researchers write “The objectives of surgical therapy in patients with morbid obesity are reduction of body weight, and a positive influence on the obesity-related comorbidity as well the concomitant psychologic and social restrictions of these patients.”

To perform this study, Champault et al. (2006) studies 152 patients who had a gastric banding system implanted between October 1999 and January 2001.  After surgery, the team found that “BMI dropped from 44.3 to 29.6 kg/m and all comorbid conditions improved markedly: diabetes melitus resolved in 71% of the patients, hypertension in 33%, and sleep apnea in 90%”, showing that gastric banding was indeed quite effective.

It was also found, however, that “26 patients (17%) had late complications requiring reoperation.”  This represents more than a 300% increase in reoperation rates compared to those reported by Allergan, the manufacturer of the ever popular LAP-BAND gastric banding system.

With the publication of papers such as this, demonstrating such a discrepancy between risk rates reported by manufacturers and those determined by independent researchers, a number of LAP-BAND lawsuits were filed.

 

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Published in 2002, JB Dixon and PE O’Brien co-authored a paper titled “Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding.” that aimed to “examine the effect of weight loss 1 year after laparoscopic adjustable gastric band surgery on a broad range of health outcomes in 50 diabetic subjects.”  This paper appeared in the February 2002 edition of Diabetes Care.

Researchers found that before surgery, mean weight was “137 +/- 30 kg,” and mean body mass index (BMI) was 48.2 +/- 8kg/m2, and that after one year using the gastric banding systems, “weight and BMI were 110 +/- 24 kg and 38.7 +/- 6 kg/m2, respectively.”  Clearly, gastric banding is an effective means of weight reduction in obese patients.  Further, relating to diabetes, “There was significant improvement in all measures of glucose metabolism” and “Remission of diabetes occurred in 32 patients (64%), and major improvement of glucose control occurred in 13 patients (26%)”.

While the study found “Improvement in diabetes was related to increased insulin sensitivity and beta-cell function” and that “Weight loss was associated with significant improvements in fasting triglyceride level, HDL cholesterol level, hypertension, sleep, depression, appearance evaluation, and health-related quality of life”, the team also found evidence of serious complications associated with the use of gastric banding systems.

“Early complications occurred in 6% of patients (wound infections in 4%, respiratory support in 2%), and late complications occurred in 30% of patients (gastric prolapse in 20%, band erosion in 6%, and tubing leaks in 4%). All late complications were successfully revised surgically.”

According to the warning label for LAP-BAND by Allergan, only about 1-2% of patients will suffer band erosion, and only about 8% are expected to suffer gastric prolapse.  The rate for tubing leaks is also lower according to Allergan.

As a result of such discrepancies between independent studies and Allergan’s LAP-BAND Warning Label, a number of LAP-BAND lawsuits were filed.

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

A 2007 report titled “Benchmarking hospital outcomes for laparoscopic adjustable gastric banding.” by MA Edwards et al. published in Surgical Endoscopy set out to review the safety and efficacy of gastric banding systems in obese patients.  Gastric banding is a procedure by which an adjustable plastic band is placed around the stomach to make patients feel full after consuming less food.

Researchers studied “87 consecutive patients with a mean age of 43 years” over 24 months, and “conducted a retrospective review of the outcomes including conversion, reoperation, mortality, perforation, erosion, prolapse, port dysfunction, excess weight loss, and changes in comorbidities, then compared the data with published benchmarks.”

Complications surrounding surgery included “acute stoma obstruction” (one patient), and respiratory complications (two patients).  “Delayed complications included gastric prolapse” (four patients) “and port reservoir malposition” (also in four patients).  Researchers also noted that 5 of 87 bands had to be removed.  All of this was seen at the two-year endpoint.

Excess weight loss, on average, was 30% at 6 months, 41% at 12 months, and 47% at 24 months.  Furthermore, researchers found that “Comorbidities resolved included diabetes (74%), hypertension (57%), gastroesophageal reflux disease (55%) and dyslipidemia (38%).” (hyperlink added)

However, it is important to realize that the rates for the above complications are significantly higher than the rates for the same complications reported in the LAP-BAND Warning Label, a popular gastric banding system manufactured by Allergan.

That warning label suggests that about 2.7% of LAP-BANDs will require removal, and the above study suggests the rate is closer to 5.7%.  Further, the LAP-BAND Warning Label suggests that only about 1.34% of patients will suffer port problems, while this study found about 4.6% of patients will face that complication.

In the face of such discrepancies, a number of LAP-BAND lawsuits have been filed.

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

In a paper published in a 2006 edition of Obesity Surgery, titled “Re-operation after laparoscopic adjustable gastric banding leads to a further decrease in BMI and obesity-related co-morbidities: results in 33 patients”, R. Schouten et al. write “Laparoscopic adjustable gastric banding (LAGB) is a safe technique with few direct postoperative complications. However, long-term complications such as slippage and pouch dilatation are a well-known problem and re-operations are necessary in a substantial number of patients.”  In this paper, “results of laparoscopic re-operations after LAGB are evaluated” in 33 patients.

Of these 33 patients who suffered failed gastric banding systems, “29 patients had major re-operation and 4 patients minor re-operation under local anesthesia”.  The team writes “The cause of band dysfunction was anterior slippage (n=17), band erosion (n=5), band intolerance (n=3), posterior slippage (n=2) and band leakage (n=2)” and that symptoms of band failure were “vomiting (n=16), pyrosis (n=13), nausea (n=8), retrosternal pain (n=11) and regurgitation (n=5).”

In this series of patients, 19 could have their bands replaced laparoscopically, while “in 3 patients, the laparoscopic procedure was converted to open surgery” and “5 patients underwent conversion to a bypass procedure”.  Thankfully, there were no complications after surgery other than wound infections in two patients.  While the body mass indexes of these patients continued to decline after reoperation, “3 patients (9%) again developed anterior slippage and a second laparoscopic re-operation was necessary.”

Sadly, the rate for primary complications associated with LAP-BANDs – a popular brand of laparoscopic adjustable gastric banding system by Allergan, Inc. – is greatly understated in the LAP-BAND Warning Label and as such, a number of LAP-BAND lawsuits were filed.

 

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry.

To that end, Congress passed the Drug Quality and Security Act (DQSA) on 11/27/2013, a law with two aims: to ensure the quality of compounded drugs, and to ensure the security of compounded drugs.  Toward the goal of ensuring drug quality, the law “Establishes annual registration requirement for any outsourcing facility” (for clarity, “outsourcing facility” means compounding pharmacy), “Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports”, and “Subjects such facilities to a risk-based inspection schedule.” (DQSA)

Toward the goal of ensuring drug security, the law “Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain” (DQSA).  According to an article by FDA Commissioner Dr. Margaret Hamburg, this will be a stepwise process taking ten years to become fully effective.  At that point, the law “will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.”

Jill Wechsler, Washington editor of the Pharmaceutical Technology blog, PharmaTech Talk, writes that of yet (just three months after the passage of DQSA), only 14 compounding pharmacies have registered with the FDA – of over 3,000 currently operating in the United States.  However, these figures ought not to be discouraging, she writes, as “this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act”.

Further, there is a disincentive for compounding pharmacies to register with the FDA including significant fees and the obligation to submit to federal regulations and inspections, and Wechsler writes the FDA is currently implementing three strategies to encourage compounding pharmacy registration.  First, the FDA is asking “hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system” by sending letters to “hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.”

Next, Commissioner Hamburg has sent letters to state governors and “members of state boards of pharmacy and state health officials” touting the benefits of the Drug Quality and Security Act, seeking state assistance in “dealing with distant compounders that ship into a state.”

Though there are certain disincentives for compounding pharmacies to register with the FDA, it must be made clear the possibilities of their commercial benefit and legal protection await.

Lastly, the FDA is aiming to encourage compounding pharmacy registration by re-establishing Pharmacy Compounding Advisory Committee, which will make new regulations.  The committee will likely be composed of “leading experts in the field” and “nonvoting representatives of pharmaceutical manufacturers and of pharmacy compounders.”

Wechsler concludes, “One important task for FDA is to develop lists of drugs that may not be compounded and lists of bulk drug substances that comply with established standards and thus may be used in compounding. FDA plans to issue new regulations to update these lists. The agency also will continue proactive and for-cause inspections of compounding pharmacies and will ‘take aggressive action’ when necessary to protect the public health.”

Though I find it incredible that compounding pharmacies had not as yet been subject to federal inspection and other such requirements, DQSA is absolutely a step in the right direction.

 

Jill Wechsler’s article from PharmaTech Talk is available here:

FDA Expands Oversight of Large Compounders

Also, the FDA provides a helpful Frequently Asked Questions page on compounding pharmacies available here:

Compounding and the FDA: Questions and Answers

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

A 2013 study by L. Angrisani et al. published in Surgery for Obesity and Related Diseases aimed to “compare outcomes of patients randomly assigned to undergo LAGB or LRYGB at 10 years.”  To be clear, “LAGB” means laparoscopic adjustable gastric banding (with systems such as LAP-BAND by Allergan) and “LRYGB” means laparoscopic Roux-en-Y gastric bypass.  Both of these are surgical methods for reducing weight in the morbidly obese.  Gastric banding involves the placement of a plastic band around the stomach to make one feel full after eating less, and gastric bypass is a procedure in which part of the small intestine is bypassed so less calories are absorbed from consumed food.

This study, titled “Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 10-year results of a prospective, randomized trial.” followed 51 patients who underwent gastric banding procedures or gastric banding patients between January 2000 and November 2000 for ten years’ follow-up, documenting all benefits and side-effects.

By ten years, eight patients “were lost to follow-up” – five gastric banding and three gastric bypass patients.  Researchers found that “Reoperations were required in 9 (40.9%) of 22 LAGB patients” and “6 (28.6%) of the 21 LRYGB patients.”  Researchers also found that after the ten years, gastric bypass patients had lost more excess weight than gastric banding patients.

Sadly, the manufacturer of the LAP-BAND gastric banding system has failed time and again to warn users of such a risk for reoperation associated with the use of their devices: the LAP-BAND Warning Label states that about 4.6% of patients will require reoperation.  As a result of such a discrepancy, a number of LAP-BAND lawsuits have been filed.

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

In a small study, the results of which published in the July 2006 edition of Archives of Surgery, a team of researchers led by WB Browne set out to determine whether patient outcome was better for super morbidly obese patients using laparoscopic adjustable gastric banding (LAGB) or laparoscopic Roux-en-Y gastric bypass (LRYGB).

Retrospectively studying 106 patients with super morbid obesity who underwent either LAGB or LRYGB between February 2001 and June 2004, and evaluated patients for “demographics, weight loss, percentage of excess weight loss, change in body mass index, early (<30 days) and late (> or =30 days) complications, reoperations, medical comorbidity, and patient satisfaction were studied.”

At follow-up (mean follow-up was just over 16 months), researchers found that “Compared with LRYGB, patients who underwent LAGB experienced a greater incidence of late complications …, reoperations …, less weight loss …, and decreased overall satisfaction”.  That is, laparoscopic adjustable gastric banding systems such as the LAP-BAND by Allergan, were found to perform worse than gastric bypass procedures.

Researchers also wrote that “patients who underwent LRYGB had a greater resolution of concomitant diabetes mellitus (P < .05) and sleep apnea (P<.01) compared with the LAGB group. Furthermore, postoperative adjustments to achieve consistent weight loss for LAGB recipients ranged from 1 to 15 manipulations” and “Our single mortality was in the LAGB group.”

Concluding that “In super morbidly obese patients, LAGB is significantly associated with more late complications, reoperations, less weight loss, less reduction of medical comorbidity, and patient dissatisfaction compared with LRYGB” and “Further evaluation of LAGB in this patient population appears warranted”, this paper could be used in a LAP-BAND lawsuit to demonstrate to court that the manufacturers of these products knew, or should have known, the risks associated with their products.

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.