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E-Articles - Gastric Bypass Complication Rates Need To Be Viewed In The Longer Term
Gastric bypass surgery (otherwise referred to as bariatric surgery or weight loss surgery) is helping many thousands of morbidly obese
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
individuals to reduce their risk from diabetes and other life-threatening conditions and to regain much of their former lifestyle. Comp
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ications from gastric bypass surgery are however significant and need to be taken into consideration before electing surgery.
Numerous
Numerous
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
studies have been carried out into gastric bypass complication rates in the short-term and these normally follow the progress of patien
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s for up to 30 days after surgery. A more recent study however (examining claims for both hospital and outpatient care for more than 5
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
illion individuals enrolled in employer sponsored health plans covering 49 states and including in excess of 2,500 weight loss patients
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
has extended the findings of previous studies to look in depth at complications arising up to 6 months after surgery.
According to th
According to th
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
study death occurred during, or in the 6 months following, surgery in only 0.2% of patients and the most common complications were dum
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ing syndrome (reflux, vomiting and diarrhea) which happened in 20% of cases, anastomosis problems (such as leakage or stricture arising
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
at the site of the join between the stomach and the intestine) which happened in 12% of cases, abdominal hernias in 7% of cases, infect
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ons in 6% of cases and pneumonia which happened in 4% of patients.
The study also found that just over 10% or patients who got through
The study also found that just over 10% or patients who got through
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the first 30 days without complication went on to experience a problem in the following 5 months. In the majority of cases these proble
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s were dumping, anastomosis problems, abdominal hernia, and marginal ulcers. In addition, although just under 5% of patients had to be
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e-admitted during the 30 day period, this figure climbed to a little over 7% when looking at the longer 6 month timeframe.
The cost of
The cost of
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
gastric bypass surgery was also affected considerably by complications and, while patients experiencing surgery without complication pa
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
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
d an average of just over $25,000, complications within the 6 month post-surgical period pushed this figure up to just over $36,500. In
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
cases where patients had to be re-admitted to hospital because of gastric bypass complications the cost rose to a little over $65,000.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Gastric bypass surgery is very much the start of the weight loss process and, unlike many forms of surgery which cure the problem more
.
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
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
r less on the spot, the results of weight loss surgery take time to show. It is not surprising therefore that problems will arise after
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
surgery and gastric bypass complications must be considered carefully before you make the decision to embark on this particular journey
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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