I’m an anecdotal person when it comes to identifying trends in the economy and how well a product is selling in the market place. Today in the NY Times, Allergan is running a full page ad (Page 21)on the merits of their LAP-BAND AP ® System. Considering this product has been on the market for awhile, this expensive advertising indicates to me that the number of patients are dwindling and maybe they are concerned with potential competition on the horizon -- (ETMR) comes to mind!
Under the Warnings and Adverse Events section that is required ,they state the following:
The PAP-BAND AP® System is a long-term implant. Explant and replacement surgery may be required at some time. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands -(With the ETMR devise, should a woman become pregnant the devise is merely turned off and can be restarted when pregnancy is over)Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in small increments. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion. Placement of the PAP-BAND AP® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body. Band slippage, erosion and deflations, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Re-operaton may be required. Rapid weight loss may result in malnutrition, anemia, or other complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Now if that isn’t a list of potential AEs that should give anyone pause before they turn to a method that ‘might’ not have as many issues! Will be interesting to see the final data from (ETMR), but at this stage of development many of the issues that apparently the Allegan method has incurred, will not apply to them. |
