Cook Medical is a 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 is the largest private global medical device manufacturer with operations in over 130 countries and an estimated $1.8 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 and sustainability practices.
One of the largest divisions of Cook Medical manufactures 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 be responsible for serious injury due to transvaginal mesh implants and the company, along with other manufacturers is facing thousands of lawsuits due to personal injury.
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. 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.
The company was nearly sold to another cardiovascular device manufacturer, Guidant in 2002 but the acquisition deal was unsuccessful and Guidant was acquired by Boston Scientific, another medical device manufacture who is also named in multiple transvaginal mesh lawsuits.
The Cook Group of companies, including Cook Medical remains in the Cook family with Carl Cook, Bill Cook’s son as CEO.
Cook Medical and Transvaginal mesh
Transvaginal mesh was modeled after other surgical mesh products used to treat tissue injuries such as hernia. Transvaginal mesh was introduced in the mid-1990’s and is approved for the surgical repair of pelvic organ prolapse and stress urinary incontinence. It was designed 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” was recalled only three years after its introduction, due to safety concerns but hundreds of additional versions of transvaginal mesh have since been introduced by a number of manufacturers including Cook Medical.
Transvaginal mesh products come in three basic categories:
- Synthetic – composed of flexible 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.
Transvaginal mesh products have caused serious adverse events which result in permanent damage. Some of these events have resulted in the death of women who have received the devices. Severe side effects caused by transvaginal mesh include:
- Vaginal erosion – the mesh erodes and may become implanted in the vaginal wall
- Organ perforation – the 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 are less stable and have 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 more remain both in federal and state or local courts. No settlements of lawsuits involving Cook Medical transvaginal mesh products have been announced and many more lawsuits may be expected.
Cook Medical in the Future
Cook Medical became a vocal opponent of the Affordable Care Act’s excise tax on medical devices in 2012. The ACA device tax of 2.3 percent was projected to raise an estimated $30 billion over 10 years to pay for part of the plan. Cook Medical has claimed the tax will cost the company an estimated $20 million annually and has stated that future expansions will take place overseas rather than in the US as planned.
Thousands of lawsuits against other manufacturers have already been settled but no announcements have been made regarding Cook Medical lawsuits.