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The Composix Kugel Mesh Patch, manufactured by Davol, Inc., a subsidiary of C.R. Bard, is a medical device used to repair ventral her

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

nias caused by the thinning or stretching of scar tissue that commonly occurs after hernia surgery. These tissues are already delica

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

Examples of combination products may in

e and sensitive, and after serious medical procedures they are even more so. The folded patch is inserted into the body behind the h

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

ernia area, where the spring-loaded plastic memory recoil holds it in place.

Unfortunately, there is a significant problem with the

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

emory recoil ring. In some cases the memory ring can break entirely which can lead to a bowel perforation or chronic enteric fistula

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

Combination pro

e, or abnormal connections between two tissues that are not normally connected. Further complicating the potential problems of the C

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

mposix Kugel Mesh Patch is that even mild pressure exerted during other surgical techniques can cause it to break and result in poten

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

tially serious consequences.

The Food and Drug Administration and Bard joined together to recall a number of defective lots of Compo

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

ix Kugel Mesh Patches due to their propensity to break. There were three different recalls that occurred in December 2005, January 2

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

006, and March 2006 that included:

• PC#0010206 Bard Composix Kugel Extra Large Oval 8.7" x 10.7"

• PC#0010207 Bard Composix Kugel

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

xtra Large Oval 10.8" x 13.7"

• PC#0010208 Bard Composix Kugel Extra Large Oval 7.7" x 9.7"

• PC#0010209 Bard Composix Kugel Oval 6

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

Following aspects would a

.3" x 12.3"

• PC#0010202 Bard Composix Kugel Large Oval 5.4" x 7"

• PC#0010204 Bard Composix Kugel Large Circle 4.5"

The problem w

dd to the challenges in developing combination products:

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

th this defective medical device is so serious that the March 24, 2006 recall stated that doctors and healthcare professionals: "Imme

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

diately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copie

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

of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already impl

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

anted with one of these products under voluntary recall."

Furthermore, the FDA recall notice stated: "Patients who have been implant

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

Professional from academic institutions, pharmaceutical industries, health care indust

d with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that c

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

ould be associated with ring breakage. These symptoms include: unexplained or persistent abdominal pain, fever, tenderness at the sur

.

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

ery site or other unusual symptoms."

The dangers of a defective medical device like the Composix Kugel Mesh Patch will likely contin

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

Companies that provide selfless information through particip

ue to affect society for quite some time. Once the public loses trust in medical device, it is difficult if not impossible to regain

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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