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Tumescent liposuction involves the surgical removal of excess body fat using a combination of traditional liposuction techniques and tumescent anesthesi

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

a. The procedure is relatively new to the cosmetic surgery scene, having come into widespread use in the 1990’s. Tumescent liposuction offers significan

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

Examples of combination products may in

t benefits over traditional liposuction techniques for its ability to minimize post-operative discomfort, curtail surgical bleeding, and reduce bruising

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

and swelling during the recovery period.

Tumescent liposuction is unique in that it uses large volumes of a dilute solution of lidocaine, paired with t

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

he drug epinephrine. The lidocaine serves as a local anesthetic, eliminating the need for patients to go under general anesthesia. The epinephrine serve

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

Combination pro

s to temporarily restrict capillaries, thereby reducing bleeding during the surgery. This combination allows surgeons to perform liposuction using minim

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

l amounts of sedatives. The lidocaine is retained in the body for several hours after the procedure, giving the patient up to 12 to18+ hours of pain-fre

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

e recovery. The use of tumescent anesthetic also eliminates the drunken feeling felt by many patients after going under general anesthesia, as well as t

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

he nausea felt by traditional liposuction patients.

At the start of the procedure, the surgeon anesthetizes the skin at select locations using tiny nee

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

les. Once the skin has been numbed, longer needles are used to anesthetize the subcutaneous fat with large quantities of the dilute lidocaine and epinep

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

hrine solution. Patients are frequently given a mild sedative, such as Valium to help relax them during the procedure. Once the areas to be treated are

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

Following aspects would a

completely numb, the doctor begins the liposuction. Small holes, called adits, are made in the skin using round skin biopsy punches to form access sites

dd to the challenges in developing combination products:

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

for the liposuction microcannulas. A microcannula is a very small stainless steel tube, ranging from 1mm to 3mm in diameter, designed to effectively rem

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

ove small amounts of fat. Fat is suctioned out of the body in small tunnels through the microcannula, leaving the fibrous strands attached to the skin a

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

nd muscles intact. Once the desired fat has been suctioned out, the microcannulas are removed. Since the adits are such small holes, there is no need fo

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

sutures using this method. This actually serves to speed up the healing process since drainage can occur via the adits, greatly reducing the amount of

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

Professional from academic institutions, pharmaceutical industries, health care indust

swelling and bruising of the treated areas.

Tumescent liposuction, as with any other type of surgical procedure, does carry some risks. Patients should

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

expect some side-effects from the procedure such as bruising, swelling, and temporary numbness of the treated areas. Significant drainage will occur in

.

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

areas where adits were formed. Some skin irregularities may result from the procedure, though this side-effect is greatly reduced with the use of both t

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

Companies that provide selfless information through particip

he tumescent anesthesia and microcannulas. Other, more serious side-effects can include blood clots, infection, and allergic reactions to the anesthesia

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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