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Weight loss surgery has advanced considerably in the past 50 years and modern forms of surgery such as gastric lap band surgery are certainly a lot safer and carry far fewer complications than e

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

arly forms of open gastric bypass surgery. Nevertheless, there are risks and these should be fully discussed with your surgeon before embarking on surgery.

Gastric lap band surgery carries a nu

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

Examples of combination products may in

mber of risks which are specific to this form of surgery but it also carries the same risks that come will all major surgeries. In addition, there are a number of general risks which accompany a

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

y surgery involving patients who are overweight.

The first and most serious risk is that of death occurring either during surgery or shortly after and directly related to surgery. At this early

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

stage (gastric lap band surgery has been around for some 12 years now but has only been licensed for use in the United States since 2001) very few deaths have been reported and it is difficult

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

Combination pro

to give a figure, although it is generally held that the risk of death from gastric lap band surgery is less than 1%.

It is interesting to note that in one study in Australia no deaths at all w

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

re reported amongst a group of 2700 patients who have undergone laparoscopic adjustable gastric banding surgery since 1994. It should be said however that Australia has been in the forefront of

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

pioneering the use of the laparoscopic adjustable gastric band and that over 90% of all weight loss surgeries conducted in Australia now use this method. This is significant as, in interpreting

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

data from this study, it should be borne in mind that the experience of the surgeon is a very significant factor in terms of both risk and complication. Surgeons with considerable experience of

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

his technique (having performed at least 100 procedures) show a very much higher success rate.

Many of the risks during surgery are general rather than "lap band" specific and are common surgic

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

al risks associated with such things as your age, weight, reaction to anesthesia and the presence of disease (whether or not this is directly related to your weight problem). The main "lap band"

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

Following aspects would a

specific risk during surgery is that of gastric perforation (a tear in the wall of the stomach) which occurs in about 1% of cases.

The vast majority of complications will occur following gastr

dd to the challenges in developing combination products:

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

c lap band surgery and most patients (in one US study the figure was as high as 88%) will experience some form of complication in the weeks and months following surgery. Such complications will

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

not necessarily be serious and will range from mild to severe.

Approximately half of all patients will suffer varying degrees of nausea and vomiting and in the region of one-third of patients w

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

ill also suffer from regurgitation (gastroesophageal reflux). About a quarter of patients will experience a slippage of the band and about one patient in seven will experience a blockage of the

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

assage between the two sections of the stomach.

Other moderate to severe problems following gastric lap band surgery can include erosion of the band into the stomach and twisting or leakage of

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

Professional from academic institutions, pharmaceutical industries, health care indust

the access port. Difficulty in swallowing (dysphagia), constipation and diarrhea are also quite common.

In a very small number of patients (less than 1%) a whole series of non-series complicati

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

ons may arise including (but not limited to) inflammation of the stomach (gastritis), migration of the stomach above the diaphragm (hiatal hernia), inflammation of the pancreas (pancreatitis), d

.

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

hydration, abdominal pain, gas (flatulence), chest pain and infection.

In general gastric lap band surgery, particularly when performed laparoscopically, carries fewer risks and complications t

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

Companies that provide selfless information through particip

han other forms of weight loss surgery, but these risks are nonetheless significant and should be fully discussed with your surgeon and understood before any decision is taken to undergo surgery

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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