Ethicon, Inc. is a subsidiary of
Johnson & Johnson
Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company i ...
. 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 suture
A surgical suture, also known as a stitch or stitches, is a medical device used to hold body tissues together and approximate wound edges after an injury or surgery. Application generally involves using a needle with an attached length of threa ...
s and wound closure devices since 1887. After
World War II
World War II or the Second World War, often abbreviated as WWII or WW2, was a world war that lasted from 1939 to 1945. It involved the vast majority of the world's countries—including all of the great powers—forming two opposin ...
, Ethicon's market share in surgical sutures rose from 15% to 70% worldwide. In the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
, the market share is approximately 80%.
Ethicon conducts business in 52 countries.
Corporate history
In 1915,
George F. Merson
George Fowlie Merson FRSE FPS FCS (1866–1959) was a Scottish pharmacist who produced an artificial surgical catgut called Mersuture. In authorship he appears as G. F. Merson.
Life
He was born in Fraserburgh in Aberdeenshire in 1866. He trained ...
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. In 1953 this became Ethicon Inc.
In 1992, Ethicon was restructured, and Ethicon Endo-Surgery became a separate
corporate entity
A corporation is an organization—usually a group of people or a company—authorized by the state to act as a single entity (a legal entity recognized by private and public law "born out of statute"; a legal person in legal context) and re ...
.
[
In 2008, Ethicon sold its wound management business to ]One Equity Partners
One Equity Partners is a private equity firm with over $10 billion in assets under management which primarily deals with the industrial, healthcare and technology sectors in North America and Europe. One Equity Partners was the merchant banking a ...
and became Systagenix Wound Management Limited.
In 2009, Ethicon acquired breast implant maker Mentor
Mentorship is the influence, guidance, or direction given by a mentor. A mentor is someone who teaches or gives help and advice to a less experienced and often younger person. In an organizational setting, a mentor influences the personal and p ...
, and in 2010 it acquired ear, nose and throat technology company Acclarent
Acclarent, Inc. began as a privately held, venture-backed company, and is now a subsidiary of Johnson & Johnson. It is based in Irvine, Orange County, California. Acclarent develops technology for ENT (Ear, Nose and Throat) related illnesses.
...
. In 2016, Ethicon acquired NeuWave Medical.
In 2013, J&J merged Ethicon Endo-Surgery back into Ethicon.
Physiomesh class action lawsuits
On June 13, 2016, Health Canada issued a recall of Ethicon's Physiomesh Flexible Composite Mesh Product used for ventral hernia repair. The product had been on the Canadian market since September 2010 and patients claimed a range of complications following surgery. The proposed Canadian class action, filed June 1, 2017 is seeking court approval for certification as a class action and is expected to proceed in 2019.
Gynecare Prolift controversy
There is some controversy around Ethicon's transvaginal meshes used on patients with female genital prolapse
Pelvic organ prolapse (POP) is characterized by descent of pelvic organs from their normal positions. In women, the condition usually occurs when the pelvic floor collapses after gynecological cancer treatment, childbirth or heavy lifting.
In me ...
.
Ethicon's ''Gynecare Prolift'', was introduced in March 2005, bypassing FDA review. The company felt its basic polypropylene had already been approved and therefore it did not need to reapply for clearance for its Prolift kit. Three years later, when Ethicon tried to obtain clearance for its Prolift +M, the FDA was alerted to the fact that Prolift had been on the market. The agency approved the Prolift and Prolift +M with no penalty. Both were cleared through the Food and Drug Administrations 510(k) clearance process, that is clearance to sell. Ethicon's parent company Johnson & Johnson utilized the FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
's ''510(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 escalated in 2011 when 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
Reuters ( ) is a news agency owned by Thomson Reuters Corporation. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide. Reuters is one of the largest news agencies in the world.
The agency was estab ...
, the plaintiff
A plaintiff ( Π in legal shorthand) is the party who initiates a lawsuit (also known as an ''action'') before a court. By doing so, the plaintiff seeks a legal remedy. If this search is successful, the court will issue judgment in favor of the p ...
, 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.
References
{{Authority control
Health care companies based in New Jersey
Companies based in Somerset County, New Jersey
Johnson & Johnson subsidiaries
Health care companies established in 1949
1949 establishments in New Jersey
Medical technology companies of the United States