Ethicon Inc.

Last updated
Ethicon
FormerlyG.F.Mersons Limited, Ethicon Suture Laboratories
Type Subsidiary
IndustrySurgical systems and instruments
Founded1915 (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 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.

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]

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

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. [15] 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. [16]

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. [17]

Related Research Articles

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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.

Boston Scientific U.S.-based medical device company

Boston Scientific Corporation, doing business as Boston Scientific, is a manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.

Implant (medicine) Medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure

An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone, or apatite depending on what is the most functional. In some cases implants contain electronics e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.

Adjustable gastric band

A laparoscopic adjustable gastric band, commonly called a lap-band, A band, or LAGB, is an inflatable silicone device placed around the top portion of the stomach to treat obesity, intended to decrease food consumption.

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.

Umbilical hernia

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.

Prolene

Prolene is a synthetic, monofilament, nonabsorbable polypropylene suture. It 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.

Stress incontinence Form of urinary incontinence due to an inadequate closer of the bladdertae

Stress incontinence, also known as stress urinary incontinence (SUI) or effort incontinence is a form of urinary incontinence. It is due to inadequate closure of the bladder outlet by the urethral sphincter.

Breast implant 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.

Uterine prolapse

Uterine prolapse is when the uterus descends towards or through the opening of the vagina. Symptoms may include vaginal fullness, pain with sex, trouble urinating, urinary incontinence, and constipation. Often it gets worse over time. Low back pain and vaginal bleeding may also occur.

Surgical staple

Surgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of the bowels or lungs. The use of staples over sutures reduces the local inflammatory response, width of the wound, and the time it takes to close.

Surgical suture

Surgical suture is a medical device used to hold body tissues together after an injury or surgery. Application generally involves using a needle with an attached length of thread. A number of different shapes, sizes, and thread materials have been developed over its millennia of history. Surgeons, physicians, dentists, podiatrists, eye doctors, registered nurses and other trained nursing personnel, medics, clinical pharmacists and veterinarians typically engage in suturing. Surgical knots are used to secure the sutures.

Mentor Worldwide LLC is an American company that supplies surgical aesthetics products to plastic surgeons. The company is based in Santa Barbara, California. 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.

Vaginal vault

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

C. R. Bard

C. R. Bard, Inc., now branded simply as Bard, headquartered in Murray Hill, New Jersey, USA, was a developer, manufacturer, and marketer of medical technologies in the fields of vascular, urology, oncology, and surgical specialties before its acquisition by BD.

Inguinal hernia surgery

Inguinal hernia surgery is an operation to repair a weakness in the abdominal wall that abnormally allows abdominal contents to slip into a narrow tube called the inguinal canal in the groin region.

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.

Biomesh

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.

Surgical mesh

Surgical mesh is a loosely woven sheet which is used as either a permanent or temporary support for organs and other tissues during surgery. Surgical mesh is created from both inorganic and biological materials and is used in a variety of surgeries. Though hernia repair surgery is the most common application, it can also be used for reconstructive work, such as in pelvic organ prolapse.

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.
  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. "Health Canada Physiomesh Recall". Health Canada. Retrieved 7 February 2019.
  13. "Canadian Patients Join Class Action Lawsuit Over Hernia Mesh". CTV News. Retrieved 7 February 2019.
  14. "Physiomesh (Hernia Mesh) Class Action Lawsuit". Murphy Battista LLP. Retrieved 7 February 2019.
  15. Linda Gross Prolift Trial Atlantic City, NJ Superior Court, 2013.
  16. "Ethicon Gynecare Prolift Mesh - Vaginal Mesh Lawsuit". Girard Gibbs. Retrieved 1 October 2017.
  17. "Week Ahead in Health: March 2, 2015". Reuters . 2 March 2015. Retrieved 1 October 2017.