Ethicon

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Ethicon, Inc.
FormerlyG.F.Mersons Limited, Ethicon Suture Laboratories
Company type Subsidiary
IndustrySurgical systems and instruments
Founded1915;109 years ago (1915), in Edinburgh, Scotland
FounderGeorge F. Merson
Headquarters Bridgewater, New Jersey and Cincinnati, Ohio [1]
Area served
Worldwide
Key people
Michael Del Prado (chairman) [2]
Andrew Ekdahl (president)
ProductsProlene, Monocryl, Vicryl, Ethilon, Gynecare
Revenue$4.87 billion (sales) [3]  (2011)
Number of employees
11,000
Parent Johnson & Johnson
Website ethicon.com

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

Contents

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.[ citation needed ] In the United States, the market share is approximately 80%.[ citation needed ]

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 became a separate corporate entity. [6]

In 2008, Ethicon sold its wound management business to One Equity Partners and became Systagenix Wound Management Limited. [7]

In 2009, Ethicon acquired breast implant maker Mentor, [8] [9] and in 2010 it acquired ear, nose and throat technology company Acclarent. [10] In 2016, Ethicon acquired NeuWave Medical. [11]

In 2013, J&J merged Ethicon Endo-Surgery back into Ethicon. [6]

As of Septemberr 10, 1024, Ethicon began operating under the name Johnson & Johnson MedTech. [12]

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. [13] The product had been on the Canadian market since September 2010 and patients claimed a range of complications following surgery. [14] 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. [15]

Gynecare Prolift controversy

There is some controversy around Ethicon's transvaginal meshes used on patients with female genital prolapse.

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. [16] Ethicon's parent company Johnson & Johnson utilized the FDA'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. [17]

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. [18]

Related Research Articles

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Johnson & Johnson (J&J) is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a component of the Dow Jones Industrial Average, and the company is ranked No. 40 on the 2023 Fortune 500 list of the largest United States corporations. In 2023, the company was ranked 40th in the Forbes Global 2000. Johnson & Johnson has a global workforce of approximately 130,000 employees who are led by the company's current chairman and chief executive officer, Joaquin Duato.

Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; neurosurgical, neurovascular and spinal devices; as well as other medical device products used in a variety of medical specialties.

<span class="mw-page-title-main">Medtronic</span> Irish tax-registered medical device company

Medtronic plc is an American-Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies. It is one of the biggest medical tech companies in the world and is currently the largest medical device company in the world by revenue.

<span class="mw-page-title-main">Pelvic organ prolapse</span> Descent of the pelvic organs from their normal positions

Pelvic organ prolapse (POP) is characterized by descent of pelvic organs from their normal positions into the vagina. In women, the condition usually occurs when the pelvic floor collapses after gynecological cancer treatment, childbirth or heavy lifting. Injury incurred to fascia membranes and other connective structures can result in cystocele, rectocele or both. Treatment can involve dietary and lifestyle changes, physical therapy, or surgery.

<span class="mw-page-title-main">Umbilical hernia</span> Medical condition

An umbilical hernia is a health condition where the abdominal wall behind the navel is damaged. It may cause the navel to bulge outwards—the bulge consisting of abdominal fat from the greater omentum or occasionally parts of the small intestine. The bulge can often be pressed back through the hole in the abdominal wall, and may "pop out" when coughing or otherwise acting to increase intra-abdominal pressure. Treatment is surgical, and surgery may be performed for cosmetic as well as health-related reasons.

<span class="mw-page-title-main">Prolene</span> Brand of polypropylene for sutures and meshes

Prolene is a brand of synthetic polypropylene used in monofilament nonabsorbable sutures and meshes. The suture is indicated for skin closure and general soft tissue approximation and ligation. Its advantages include minimal tissue reactivity and durability. Disadvantages include fragility, high plasticity, high expense, and difficulty of use compared to standard nylon sutures.

<span class="mw-page-title-main">Breast implant</span> Prosthesis used to change the size, shape, and contour of a persons breast

A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery.

<span class="mw-page-title-main">Uterine prolapse</span> Medical condition

Uterine prolapse is a form of pelvic organ prolapse in which the uterus and a portion of the upper vagina protrude into the vaginal canal and, in severe cases, through the opening of the vagina. It is most often caused by injury or damage to structures that hold the uterus in place within the pelvic cavity. Symptoms may include vaginal fullness, pain with sexual intercourse, difficulty urinating, and urinary incontinence. Risk factors include older age, pregnancy, vaginal childbirth, obesity, chronic constipation, and chronic cough. Prevalence, based on physical exam alone, is estimated to be approximately 14%.

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Coloplast A/S is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care.

Mentor Worldwide LLC is an American company that supplies surgical aesthetics products to plastic surgeons. The company is based in Santa Barbara, California and is part of Johnson & Johnson MedTech business segment. It produces one of two silicone gel breast implants. Titled MemoryGel, the product was approved by the U.S. Food and Drug Administration (FDA) on November 17, 2006. The other FDA-approved products are developed by competitors Allergan and Sientra. Mentor also produces a range of lipoplasty equipment for liposuction procedures as well as a Niacin-based skincare product line called NIA 24.

Synthes Holding AG is a multinational medical device manufacturer based in Solothurn, Switzerland and West Chester, Pennsylvania, United States. It is the world's largest maker of implants to mend bone fractures, and also produces surgical power tools and advanced biomaterials.

<span class="mw-page-title-main">Vaginal vault</span>

The vaginal vault is the expanded region of the vaginal canal at the internal end of the vagina.

<span class="mw-page-title-main">Bard (company)</span> Pharmaceutical company

C. R. Bard, Inc., headquartered in Murray Hill, New Jersey, USA, was a developer, manufacturer, and marketer of medical technologies in the vascular medicine, urology, oncology, and surgical specialty fields. C. R. Bard marketed its products and services worldwide to hospitals, individual health care professionals, extended care facilities, and alternate site facilities. An S&P 500 company with approximately 14,000 employees in 2015, Bard is perhaps best known for having introduced the Foley catheter in 1934.

<span class="mw-page-title-main">Biomesh</span> Surgical mesh from biomaterial

Biomesh is a type of surgical mesh made from an organic biomaterial. Biologic mesh is primarily indicated for several types of hernia repair, including inguinal and ventral hernias, hernia prophylaxis, and contaminated hernia repairs. However, it has also been used in pelvic floor dysfunction, parotidectomy, and reconstructive plastic surgery. The development of biologic mesh largely has derived from the need of a biocompatible material that addresses "the problems associated with a permanent synthetic mesh, including chronic inflammation, foreign body reaction, fibrosis, and mesh infection." As of 2015, however, the efficacy and optimal use of biological mesh products remains in question.

<span class="mw-page-title-main">Surgical mesh</span> Material used in surgery

Surgical mesh is a medical implant made of loosely woven mesh, which is used in surgery as either a permanent or temporary structural support for organs and other tissues. Surgical mesh can be made from both inorganic and biological materials and is used in a variety of surgeries, although hernia repair is the most common application. It can also be used for reconstructive work, such as in pelvic organ prolapse or to repair physical defects created by extensive resections or traumatic tissue loss.

Transvaginal mesh, also known as vaginal mesh implant, is a net-like surgical tool that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) among female patients. The surgical mesh is placed transvaginally to reconstruct weakened pelvic muscle walls and to support the urethra or bladder.

<span class="mw-page-title-main">Ovine forestomach matrix</span> Regenerative medical device platform

Ovine forestomach matrix (OFM) is a layer of decellularized extracellular matrix (ECM) biomaterial isolated from the propria submucosa of the rumen of sheep. OFM is used in tissue engineering and as a tissue scaffold for wound healing and surgical applications

Ventral rectopexy is a surgical procedure for external rectal prolapse, internal rectal prolapse, and sometimes other conditions such as rectocele, obstructed defecation syndrome, or solitary rectal ulcer syndrome. The rectum is fixed into the desired position, usually using a biological or synthetic mesh which is attached to the sacral promontory. The effect of the procedure is correction of the abnormal descended position of the posterior compartment of the pelvis, reinforcement of the anterior (front) surface of the rectum, and elevation of the pelvic floor. In females, the rectal-vaginal septum is reinforced, and there is the opportunity to simultaneously correct any prolapse of the middle compartment. In such cases, ventral rectopexy may be combined with sacrocolpopexy. The surgery is usually performed laparoscopically.

References

  1. "Locations around the world". Ethicon U.S. Retrieved 25 January 2016.
  2. Perriello, Brad (22 May 2014). "J&J's pipeline includes 30 'major' medical devices and a surgical robot". MassDevice. Retrieved 25 January 2016.
  3. "Management's Discussion and Analysis of Results of Operations and Financial Condition" (PDF). Johnson & Johnson. 2011. p. 29. Archived from the original (PDF) on 2 February 2016. Retrieved 25 January 2016.
  4. "ETHICON History". Ethicon Products.co.uk. Archived from the original on 10 January 2016. Retrieved 25 January 2016.
  5. "A history of advancing surgery". Ethicon U.S. Retrieved 25 January 2016.
  6. 1 2 Arnold, Matthew (8 May 2013). "J&J consolidates, rebrands Ethicon units". Medical Marketing & Media.
  7. Garde, Damian (30 July 2013). "KCI buying ex-J&J unit for $485M". FierceBiotech. Retrieved 2020-11-10.
  8. "Johnson & Johnson Completes $1.07 bln. Acquisition Of Mentor". RTTNews. 23 January 2009. Retrieved 2020-11-10.
  9. Krauskopf, Susan Kelly, Lewis (2008-12-01). "J&J to buy breast implant firm Mentor for $1.1 billion". Reuters. Retrieved 2020-11-10.{{cite news}}: CS1 maint: multiple names: authors list (link)
  10. "J&J Inhales Sinus Device Maker for $785M". Forbes. Retrieved 2020-11-10.
  11. Brunsman, Barrett (14 April 2016). "Ethicon acquires maker of cancer-killing devices". Cincinnati Business Courier.
  12. "Johnson & Johnson consolidates medtech brands under single banner". FIERCE Biotech. Sep 10, 2024.
  13. "Health Canada Physiomesh Recall". Health Canada. Retrieved 7 February 2019.
  14. "Canadian Patients Join Class Action Lawsuit Over Hernia Mesh". CTV News. Retrieved 7 February 2019.
  15. "Physiomesh (Hernia Mesh) Class Action Lawsuit". Murphy Battista LLP. Retrieved 7 February 2019.
  16. Linda Gross Prolift Trial Atlantic City, NJ Superior Court, 2013.
  17. "Ethicon Gynecare Prolift Mesh - Vaginal Mesh Lawsuit". Girard Gibbs. Retrieved 1 October 2017.
  18. "Week Ahead in Health: March 2, 2015". Reuters . 2 March 2015. Retrieved 1 October 2017.