Ethicon Inc.

Ethicon

Formerly called	G.F.Mersons Limited, Ethicon Suture Laboratories
Type	Subsidiary
Industry	Surgical systems and instruments
Founded	1915 (1915) in Edinburgh, Scotland
Founder	George F. Merson
Headquarters	Somerville, New Jersey and Cincinnati, Ohio[1]
Area served	Worldwide
Key people	Michael Del Prado (chairman)[2]
Products	Prolene, Monocryl, Vicryl, Ethilon, Gynecare
Revenue	$4.87 billion (sales)[3] (2011)
Number of employees	11,000
Parent	Johnson & Johnson
Website	www.ethicon.com

Ethicon, Inc. is a subsidiary of Johnson & Johnson. It was incorporated as a separate company under the Johnson & Johnson umbrella in 1949 to expand and diversify the Johnson & Johnson product line.

Ethicon has manufactured surgical sutures and wound closure devices since 1887. After World War II, Ethicon’s market share in surgical sutures rose from 15% to 70% worldwide. In the United States, the market share is approximately 80%.

Ethicon conducts business in 52 countries.

Corporate History

In 1915, George F. Merson opened a facility in Edinburgh for the manufacturing, packaging and sterilising of catgut, silk and nylon sutures. Johnson & Johnson acquired Mr. Merson’s company in 1947, and this was renamed Ethicon Suture Laboratories.^[4] In 1953 this became Ethicon Inc.^[5]

In 1992, Ethicon was restructured, and Ethicon Endo-Surgery, Inc. became a separate corporate entity.

During the 1990s, Ethicon diversified into new and advanced products and technologies and formed four different companies under the Ethicon umbrella, each of which specialize in different products.

In November 2008, the wound management business was sold to One Equity Partners and became Systagenix Wound Management Limited.

In 2009, Ethicon acquired breast implant maker Mentor, and in 2010 it acquired ear, nose and throat technology company Acclarent.

Prolift controversy

Much controversy surrounds Ethicon's transvaginal meshes used on patients with female genital prolapse.

Of these meshes the most important, Ethicon’s Gynecare Prolift, was introduced in March 2005. Ethicon's parent company Johnson & Johnson utilized the FDA’s 501(k) clearance method, which allows a product to be sold without official FDA approval if it is based on another already approved product. However, in 2008, the FDA issued a Public Health Notification regarding reports of serious complications associated with transvaginal mesh devices. This further escalated when, in 2011, the agency received more than 1,000 adverse effect reports from surgical mesh manufacturers. The FDA decided to order Ethicon and other transvaginal mesh manufacturers to cease production until extensive testing and research on each of vaginal mesh device was conducted. In June 2012, following the FDA’s order for additional testing, Johnson & Johnson permanently removed all Prolift products from the market.^[6]

In one court case reported by Reuters, the plaintiff, Dianne Bellew, on whom the product had been implanted in 2009, said she was never warned about how the device could contract and erode, causing pain and scarring.^[7]

Products and brands

• Prolene, Monocryl, Vicryl, and Ethilon
• Gynecare: women's health products.

Further reading

• Lance Williams "How suture maker kept lid on infection suits: Despite recall, Ethicon said product was harmless" San Francisco Examiner February 22, 1999
• recall enforcement, U.S. Food and Drug Administration

References