Ethicon Inc.

Ethicon, Inc. logo

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 for over a century. 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%. The most popular Ethicon sutures remain Prolene, Monocryl, Vicryl, and Ethilon.

Ethicon is headquartered in Somerville, New Jersey. It currently conducts business in 52 countries and employs approximately 11,000 people.

Corporate History

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.

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.

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.

Ethicon Companies

• Ethicon products: suture products and suture technology.
• Gynecare: women's health products.
• Acclarent: an ear, nose and throat technology company acquired in 2010.

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
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• recall enforcement, U.S. Food and Drug Administration