Implantable catheter products, sometimes called “ports,” are medical devices used to provide long-term access to major veins in the body. The device is implanted in the body and sits just under the skin, allowing repeat access for the delivery of medications, fluids, nutrition, or blood. These devices are commonly used during treatment for cancer patients undergoing chemotherapy or in patients diagnosed with certain autoimmune disorders.
Some implanted catheter products have been demonstrated to break down and fracture in a person’s body, creating an ideal environment for bacteria and infection to develop.
Scientific studies connect implantable catheters with a risk of harm
Bard Access Systems, Inc. (“Bard”) is a producer of medical device products. Implantable catheter products produced by Bard, including the “PowerPort” devices, have been demonstrated to have a higher rate of device failure than similar devices produced by other companies.
Several scientific articles have found a significant association between the mechanical failure of these devices and the development of severe injuries and complications.
The National Library of Medicine 2006 study, Complications associated with an implantable vascular access device, reported of over 300 patients with implantable catheter products – the largest percentage of which were made by Bard – found that, significantly, over 5% of devices had mechanical issues.
Another National Library of Medicine study from 2010, The mechanisms of failure of totally implantable central venous access system, examined device failures and fractures among a sample of over 3,000 devices. In this study, Bard products comprised the largest segment of problematic devices.
Hidden reporting of adverse events
In the past, the U.S. Food and Drug Administration (the FDA) allowed some medical companies to report “adverse events” with their products in two different databases: the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database and the private Alternative Summary Reporting (ASR) Program database. The ASR Program was intended to be for issues that were well-known and well-documented with the FDA. However, following intense public pressure, the private database was ended, and millions of private medical device reports were made public.
Following the release of the private adverse event reports, it became evident that issues with fractures in Bard’s implantable catheter products had been known for many years.
In March 2020, the FDA issued recalls of several Bard implantable catheter devices. The recalls related to catheter fracture issues and migration, infection, and thrombosis (blood clots).
Complications associated with catheter product failure
Mechanical failure or fractures of implanted catheter products can cause serious harm, including:
- Catheter removal or replacement
- Infection and/or sepsis
- Thrombosis (blood clots) and embolism
- Heart attack
Bard PowerPort Implantable Catheter class action
Siskinds LLP and Siskinds’ Québec-based affiliate, Siskinds, Desmeules, are seeking to recover compensation for Canadians who suffered injuries arising from the implantation of certain catheter products. Siskinds, Desmeules has filed a class action alleging that the makers of PowerPort and other implantable catheter products failed to adequately warn users, and their health care providers, that their implantable catheter products increase the risk of serious complications, including infection, sepsis, blood clots, heart attack, stroke, and death.
Eligibility for participation
If you or someone you know has had a catheter product implant and has suffered a major complication, Siskinds may be able to help. For a free consultation, contact us by email at [email protected] or call 1-800-461-6166. To learn more about the progress of this class action, visit siskinds.com/catheters.