About Cook Medical
Cook Medical is a privately-owned Bloomington, Indiana based medical device manufacturer whose product line includes intervention devices in 60 clinical specialties including 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 and other business units.
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 caused by bladder slings and transvaginal mesh and the FDA has ordered all manufacturers to stop selling and distributing these products.
History of Cook Medical
Cook Medical was founded in 1963, by Bill and Gayle Cook. In collaboration with a number of physicians, the company developed groundbreaking products and procedures in the surgical medical device industry.
Cook’s first products included the first pre-packaged kit for percutaneous catheterization for cardiovascular procedures which included needles, wire guides and catheters, angioplasty devices, cardiovascular stents and cardiac filters, and urinary catheters and anchor systems. 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, Vascular and MedSurg (surgical), with specialty subdivisions equally placed depending on type of intervention and device. The product list includes over 650 devices in 60 clinical 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 interventional procedures.
Though the company still makes a number of surgical mesh products, now called Hernia or Tissue “Graft” devices, it was once a major producer of transvaginal mesh and bladder sling products.
Cook no longer manufacturers transvaginal mesh, and 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.
Cook Medical and IVC Filters
Invented in the late 1960s, Cook Medical was one of the first manufacturers of Intravenous Vena Cava (IVC) filters. IVC filters are intended to be inserted into the largest vein of the heart, the vena cava. The filters are designed to catch any blood clots that have formed in the heart or other areas before they can be transported to the lungs. This may help to prevent a potentially fatal and serious condition known as Pulmonary Embolism.
IVC filters were initially designed to be permanent. Once inserted, they were to be left in place, however by the early 2000s, device manufacturers began addressing serious concerns about complications. Multiple manufacturers began introducing temporary IVC filters which were intended to be left in place for a number of weeks or months and removed. Many of these devices, however, were left in place much longer and in some cases, permanently.
By 2005, the FDA had received numerous complaints of temporary IVC filter devices which fractured, leaving parts free to break off and travel to other organs. Serious adverse events caused by temporary IVC filters included lung and organ perforation, hemorrhage, stroke, and death.
In 2010, the FDA issued a safety communication highlighting the dangers of temporary IVC filters. A study conducted by the American Medical Association which confirmed that filters left in place, were more likely to cause serious adverse events included concerns about the Cook Medical Gunther Tulip and Celect (temporary) IVC filters. The FDA safety alert was updated in 2014, to warn of serious adverse events which occurred in up to 80% of temporary IVC filters and to recommend that temporary IVC filters be removed within on or two months. Cook has not recalled or discontinued selling their IVC filters. Thousands of medical injury lawsuits were filed against Cook Medical for adverse events caused by the Gunther Tulip and Celect IVC filters. These lawsuits were consolidated into multidistrict litigation (MDL) with other manufacturers. Though three bellwether trials were conducted, one of which resulted in a $1.2 million settlement for the plaintiff, COVID-19 delayed further court action. Some lawsuits may have been settled out-of-court, but a large-scale settlement has not been announced.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- History, Cook Medical (2022)
- FDA Safety Communication: UPDATE on Serious Complications Associated With Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, U.S. Food and Drug Administration (2011)
- FDA’s Activities: Urogynecologic Surgical Mesh, U.S. Food and Drug Administration (2020)
- Urogynecologic Surgical Mesh Implants, U.S. Food and Drug Administration (2020)
- FDA News Release: FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices, U.S. Food and Drug Administration (04/2019)
- FDA Updates Safety Communication on IVC Filter Retrieval, Endovascular Today (05/2014)