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The vertical sleeve gastrectomy is a restrictive form of weight loss surgery in which approximately 85% of the stomach is removed leaving a cylindrical or

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

sleeve shaped stomach with a capacity ranging from about 60 to 150 cc, depending upon the surgeon performing the procedure. Unlike many other forms of bari

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

atric surgery, the outlet valve and the nerves to the stomach remain intact and, while the stomach is drastically reduced in size, its function is preserve

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

d. Again, unlike other forms of surgery such as the Roux-en-Y gastric bypass, the vertical sleeve gastrectomy is not reversible.

Because the new stomach c

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ntinues to function normally there are far fewer restrictions on the foods which patients can consume after surgery, albeit that the quantity of food eaten

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

will be considerably reduced. This is seen by many patients as being one of the great advantages of the vertical gastrectomy, as is the fact that the remo

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

val of the majority of the stomach also results in the virtual elimination of hormones produced within the stomach which stimulate hunger.

Perhaps the gre

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

test advantage of the vertical sleeve gastrectomy lies in the fact that it does not involve any bypass of the intestinal tract and patients do not therefor

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e suffer the complications of intestinal bypass such as intestinal obstruction, anemia, osteoporosis, vitamin deficiency and protein deficiency. It also ma

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

kes it a suitable form of surgery for patients who are already suffering from anemia, Crohn's disease and a variety of other conditions that would place th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

m at high risk for surgery involving intestinal bypass.

Finally, it is one of the few forms of weight loss surgery which can be performed laparoscopically

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

in patients who are extremely overweight.

Perhaps the main disadvantage of the vertical sleeve gastrectomy is that it does not always produce the weight

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

loss which people would wish for and, in the longer term, can result in weight regain. This is indeed true of any form of purely restrictive weight loss su

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

rgery, but is perhaps especially true in the case of the vertical gastrectomy.

Because the procedure requires stapling of the stomach patients do run the

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

isk of leakage and of other complications directly related to stapling. In addition, as with any surgery, patients run the risk of additional complications

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

such as post-operative bleeding, small bowel obstruction, pneumonia and even death. The risk of encountering any of these complications is however extreme

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ly small and varies from about 0.5 and 1%. Having said this, the risk of death from this form of surgery at about 0.25% is extremely small.

As a general r

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

le the vertical sleeve gastrectomy is best suited to individuals who are either extremely overweight or whose medical condition would rule out other forms

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

of weight loss surgery. In the case of the former the vertical sleeve gastrectomy would normally form the first of a two-part plan of weight loss, with fur

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ther bariatric surgery being performed once the patient's weight has fallen sufficiently to allow for other forms of weight loss surgery to come in to play

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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The article describes the problems being faced by the world due to lack of spiritual values. It highlights the need for controlling our desires and giving equal importance to material prosperity and spiritual life.

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