Cook Medical

Cook Medical is the largest private, global medical device manufacturer, whose product lines include devices for cardiology, gastroenterology, gynecology, and other areas. One of the largest divisions of Cook Medical manufactures transvaginal mesh products which have resulted in serious injury for many women who received them for uterine and bladder repair.

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About Cook Medical

Cook Medical is a privately-owned Bloomington, Indiana based medical device manufacturer whose product line includes intervention devices for cardiology, gastroenterology, urology, vascular medicine, radiology, and gynecology. It is a division of Cook Group Incorporated which is an umbrella organization for a number of medical manufacturing companies.

Cook Medical has operations in 135 countries and an estimated $2 billion in yearly revenue. The company manufactures thousands of minimally invasive devices and supplies 13 large hospital chains. Cook Medical has also developed Healthcare Business solutions to help healthcare institutions with implementation of global standards regarding medical devices, e-commerce, electronic data interchange, and sustainability practices.

One of the largest divisions of Cook Medical manufactured transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.  Several of the devices manufactured by Cook may have been responsible for serious injury due to transvaginal mesh implants.

Cook, along with other manufacturers has faced thousands of lawsuits due to personal injury and the FDA has ordered all transvaginal mesh manufacturers to stop selling and distributing these products.

History of Cook Medical

Cook Medical was founded in 1963 Bill Cook. The company developed the first pre-packaged kit for percutaneous catheterization for cardiovascular procedures which included needles, wire guides and catheters.  By the end of the 1970’s, the company had expanded to Europe and Asia and was producing nearly one million cardiac catheterization devices annually.

The company introduced the first intravascular cardiac stent in the 1990’s and continued to expand by acquiring additional companies and expanding into different therapeutic areas. By the end of the decade, Cook Medical was the largest privately owned medical device manufacturer in the world as it remains today.

The Cook Group of companies, including Cook Medical remains in the Cook family with Carl Cook, Bill Cook’s son as CEO.

Cook Medical Products

Cook Medical was recently reorganized into two large divisions, Surgical and Vascular, with specialty subdivisions equally placed depending on type of intervention and device. The product list includes over 600 devices in 24 specialty areas.

Popular products range from interventional cardiology devices like stents and catheters to surgical products for a variety of minimally invasive procedures, many of which are done through an endoscopic, laparoscopic, or other surgical procedures.

Though the company still makes a number of surgical mesh products and was once a major producer of transvaginal mesh and bladder sling products, the U.S. Food and Drug Administration has ordered that manufactures discontinue selling and distributing transvaginal mesh or bladder mesh products in the U.S.

Cook Medical and Transvaginal Mesh

Introduced in the 1990s, transvaginal mesh was modeled after other surgical mesh products used to treat tissue injuries such as hernia. It was approved for the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Transvaginal mesh was intended to be safer and more effective than traditional suspension surgeries as the mesh is implanted through the vagina or “transvaginally” rather than through a large abdominal incision.

The first “bladder sling”, constructed of surgical mesh, was recalled only three years after its introduction, due to safety concerns but hundreds of additional versions of transvaginal mesh were subsequently introduced by a number of manufacturers including Cook Medical.

Transvaginal mesh products included 3 basic categories:

  • Synthetic – composed of flexible polymer plastic
  • Biologic – composed of natural tissue
  • Combination – composed of plastic, surrounded by natural tissue

The Food and Drug Administration issued a statement in 2011, stating that transvaginal mesh products may pose a greater risk to patients than previously thought. Cook Medical asserted that its devices were safer than other manufacturers’ transvaginal mesh products as the Cook products were all composed entirely of biologic materials.

Despite the claims of safety, hundreds of patients may have been injured by Cook Medical transvaginal mesh products. In 2019, the FDA ordered that all transvaginal mesh manufacturing be halted.

Transvaginal Mesh Injuries

Transvaginal mesh products, including Cook Medical devices, may have caused serious adverse events which result in permanent damage or even death in some women. Severe side effects caused by transvaginal mesh include:

  • Vaginal erosion –mesh erodes and may become implanted in the vaginal wall
  • Organ perforation –mesh may eventually perforate the vaginal wall or other abdominal organs
  • Mesh revision surgery – surgery may be required to remove the medical device, repair damaged tissue and correct POP or SUI

Thousands of women have been injured and filed lawsuits against transvaginal mesh manufacturers. Despite Cook’s assertion of greater safety, Cook has been named hundreds of lawsuits regarding transvaginal mesh. Some patients and physicians have claimed that Cook products were actually less stable and had a greater risk of infection due to the biologic composition.

Cook Medical transvaginal mesh products that may have caused injury include:

  • Biodesign urethral slings
  • Biodesign pelvic floor grafts
  • Biodesign tissue grafts
  • Biodesign repair grafts
  • Stratasis Urethral Sling
  • Surgisis urethral slings
  • Surgisis pelvic floor grafts
  • Surgisis tissue grafts
  • Surgisis repair grafts

Thousands of transvaginal mesh lawsuits have been settled but many remain in federal, state and local courts.  Cook Medical has not announced any group settlement of transvaginal mesh lawsuits.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.