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The Facts on Power Injectable Implantable Ports

Patient safety and product quality have been top priorities at C.R Bard and BD^® since the beginning

37 years on the market with the launch of our first Non-Power Port in 1987 and first power port in 2006.

What is a Port?

A port is a small device that makes it easier for healthcare providers to access a vein. Ports help people who often need IV treatments, like chemotherapy, or blood draws. A port consists of a small plastic or metal body, a catheter, and a catheter lock. The device gets implanted beneath the skin, typically on the chest or arm. It is accessed with a special needle so medicines and fluids can be infused, and blood samples withdrawn. When a port is no longer needed, a provider will remove it.

Why did your doctor recommend a port?

You or a loved one may have received a diagnosis that requires frequent access to your vascular system, which means regular needle sticks to administer medication or draw blood samples. Here are some examples of illnesses and treatment needs requiring frequent vascular access:

Cancer that requires chemotherapy, IV fluids, or frequent blood draws
Infection that requires long-term IV antibiotics
Disease that requires parenteral (IV) nutrition

Your healthcare provider may have recommended an implantable port device to support you or your loved one’s care and treatment. A port makes it easier for healthcare providers to access a vein to deliver medications, draw blood samples, and complete blood-related therapies. With a port, you can have:

Fewer needle-sticks
At home treatments, like chemotherapy
More than one medication delivery at a time with single and dual lumen options
Multiple blood tests and treatments in the same day with just one needle stick
Reduced risk of pain, bruising, bleeding, and infections
Reduced risk of vein damage from strong medications such as chemotherapy

Why might you consider a port?

Your treatment may require frequent delivery of medicine or fluids into your bloodstream. Your healthcare provider may also require blood samples. If this is the case, a port may be an appropriate option for your treatment.

Once placed, a port can stay in place as long as your healthcare provider makes sure that it works and indicates that you still need it. While the port itself will still need to be accessed with a needle, there will be a decreased need for the sometimes painful poking and prodding when finding a peripheral vein in your arms or hands with a needle every time you receive treatment or have your blood drawn.
Since ports are placed in larger central veins, ports can reduce the likelihood of damage to the smaller veins in your arms or hands. This may benefit you if blood work or IVs are needed down the road.
Implanted ports, compared to other centrally placed vascular access devices, are more likely to permit you to go about your normal day-to-day activities, like showering and swimming. Ask your healthcare team about specific activities and the appropriate time to resume them.
With an implanted port, there is no exposed device. Implanted ports are small and can be hidden from view. No one needs to know about your treatment unless you want them to.

Risks associated with having a port

Patients who have or are suspected of having an infection, have a body size that will not allow for proper port placement or port access, are allergic to materials contained in the device, have chronic obstructive lung disease (or COPD), have had previous blood clots (thrombosis), have had a surgical procedure where the port would be placed, or have had the port insertion site exposed to radiation.

Unfortunately, a port is not for everyone. Like any vascular access procedure, there is always a risk of complications, including blood clots, skin erosion, infection, a collapsed lung, or clotting of the port catheter. Talk to your healthcare provider about these and other risks, including those listed below under “Possible Complications,” and whether a port or another treatment is right for you.

Talk to your doctor about these and other possible complications.

Air Embolism
Allergic Reaction
Bleeding
Brachial Plexus Injury
Cardiac Arrhythmia
Cardiac Puncture
Cardiac Tamponade
Catheter or Port Erosion Through the Skin
Catheter Embolism
Catheter Occlusion
Catheter or port-related Sepsis
Damage or Breakage due to Compression between the Clavicle and First Rib
Device Rotation or Extrusion
Endocarditis
Extravasation
Fibrin Sheath Formation
Guidewire Fragment Embolism
Hematoma
Hemothorax
Hydrothorax
Infection, including but not limited to pocket, catheter tunnel, and /or blood stream
Inflammation, Necrosis, or Scarring of Skin Over Implant Area
Intolerance or Reaction to Implanted Device
Laceration of Vessels or Viscus
Pain at or around port pocket site
Perforation of Vessels or Viscus
Pneumothorax
Risks Normally Associated with Local or General Anesthesia, Surgery, and Post-Operative Recovery
Spontaneous Catheter Tip Malposition or Retraction
Thoracic Duct Injury
Thromboembolism
Vascular Thrombosis
Vessel Erosion

After the procedure, you will see some redness and tenderness in the area. This should go away in 24 to 48 hours. However, contact your healthcare provider if you notice unusual changes in the skin, such as increased swelling, redness, soreness, or drainage. If you have pain, fever, chills, shortness of breath, dizziness or drainage, contact your healthcare provider right away.

DON'T FORGET!

If you recently had a port placed, review your patient discharge packet and contact your healthcare provider should you have any questions or experience any complications post-placement. Keep your ID card, wristband and/or key tag on you in case your healthcare provider has any questions about what kind of port you have.

BD, the BD Logo, Advancing the World of Health, AllPoints, C.R.Bard, ChronoFlex, ClearVUE, Groshong, MiniLoc, M.R.I., PortReady, PowerFlow, PowerPort, PowerLoc, SafeStep, SlimPort, Rosenblatt and the radiopaque identifier are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. © 2024 BD. All rights reserved.

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Types Of Ports?

Ports are available in a variety of shapes and sizes depending on a person’s treatment needs, personal preferences, and physical characteristics. Your healthcare provider will choose the best port for you.

Port Evolution

A focus on port innovation has been at the heart and soul of C.R.Bard/BD since the launch of our non-power port in 1987, and BD is committed to help improve patient outcomes by advancing the world of health™.

Today, with our broad portfolio of port options, we remain uniquely positioned to support healthcare providers, as well as patients, through our advances in port innovation. 

*BD Data on File. October 2024

In 1987, C.R. Bard/BD launched the first non-power injectable port, Titanium Implantable Port.

In 1991, C.R. Bard/BD launched the first non-power dual lumen port, MRI™ Dual Lumen Implantable Port .

In 2007, C.R. Bard/BD launched the first power injectable ports, PowerPort™ Implantable port and PowerPort™ isp M.R.I.™ implantable Port.

In 2009, C.R. Bard/BD launched the first dual lumen power injectable port, PowerPort™ Duo M.R.I™ Implantable Port.

In 2012, C.R. Bard/BD launched the first and only metal-free, MR safe power injectable port, PowerPort™ ClearVUE™ isp Implantable Port.

In 2014, C.R. Bard/BD launched the first and only 90-day flushing interval with the creation of our Groshong™ Port Catheter.

In 2017, C.R. Bard/BD launched the first and only high-flow, power injectable port designed and indicated specifically for therapeutic apheresis, PowerFlow™ Implantable Apheresis IV Port

Anatomy of a Port

How It Works

Port Catheters

ChronoFlex™

made of polyurethane and have an open, non-valved tip
Groshong™

made of silicone and have a valved tip
Silicone

made with silicone with an open, non-valved tip

Barium Sulfate

All C.R. Bard/BD port catheters contain barium sulfate, which allows the catheter to show up under x-ray imaging. This helps your healthcare provider place your port correctly, which is crucial to your port working properly during your treatment.

What is barium sulfate?

Barium sulfate is a radiographic contrast agent. Contrast agents are used to create a clear picture of the different parts of the body and can be integrated into medical devices
How is barium sulfate used in catheters?

Barium sulfate is integrated into catheter materials, like polyurethane and silicone. These catheters are rigorously tested to ensure they are safe for use. Barium sulfate has been used in port catheters since the launch of our first port in 1987.

Why do catheters contain barium sulfate?

Barium sulfate is used as a radiopacifier, which allows the catheter to be seen on an x-ray and helps physicians confirm correct port placement and catheter tip location in the body.
Barium sulfate is more common than you think.

Barium sulfate is widely used in medical devices, but it's also a drinkable liquid that is used to diagnose problems in the esophagus, stomach, and bowels. The barium sulfate lights up under x-ray imaging and helps identify medical issues, like cancer or tumors. And, it is one of the most widely used radiopacifiers.

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BD^® offers a wide range of ports and kit configurations to meet the needs of patients, port placers, and nurses.

Browse all of our port offerings below, including our premium port and visit PortReady™ Patient Resources site for more information on...

Our Premium
BD^® Port Offerings

PowerPort™ ClearVUE™
Implantable Port

Learn More

PowerFlow™ Implantable
Apheresis IV Port

Learn more

Port Access

Learn more

Patient Resources

The PortReady™ program was designed to help you to be more informed about the ways in which you can receive your treatment, with a focus on implantable ports. We believe that being empowered by knowledge and the support of others can make a difference in your journey.

Learn More

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BD^® Studies on Port Catheters

The Veins for Life Study

A retrospective, multi-centered study to assess the complication rates of implantable ports and peripheral intravenous (IV) catheters for oncology patients

LEARN MORE

The BD ChronoFlex™ Catheter vs. AngioDynamics BioFlo™ Catheter In-Vivo Thrombogenicity Study

A head-to-head, in-vivo catheter study evaluating the catheter surface clotting potential and the resultant thrombus accumulation on the catheter surface

LEARN MORE

The BD Groshong™ Distal Valved Port Catheter Study

A retrospective, multi-center data review to evaluate the maintenance flushing interval for patients using the Groshong™ Distal valved port catheter from BD.

LEARN MORE

VEINS FOR LIFE study

The purpose of the VEINS FOR LIFE study was to collect data on patients receiving chemotherapy to determine complication rates with implantable ports and peripheral IV catheters.

The VEINS FOR LIFE study showed that ports are associated with low rates of adverse events/malfunctions, most of which are manageable. Patients receiving chemotherapy through peripheral IV Catheters were more likely to experience a complication, and some peripheral IV patients converted to a port because of the complications associated with PIVs.

All patients received 8,512 infusions over the course of 2,987 chemotherapy treatments
Patients with ports could continue normal daily activities such as showering, engaging in sports, or playing with children.
The average time to convert PIVCs to ports was 59.8 days.

ChronoFlex™ vs. BioFlo™ Catheters In-Vivo Thrombogenicity Study

The purpose of the ChronoFlex™ vs. BioFlo™ Catheter Study was to evaluate the catheter surface clotting potential and the resulting thrombus accumulation on the catheter surface.

All testing was conducted by an independent, third-party facility.
Five ovine animals were implanted with BD’s ChronoFlex™ Catheter and AngioDynamics’ BioFlo™ Catheter for 31 days.
The catheters were flushed and locked with sterile saline and left for a minimum of 31 days. After 31 days, the catheters were explanted, evaluated, and assigned a thrombus score based on visual examination, an accepted evaluation method for thrombogenicity scoring.

The ChronoFlex™ Catheter vs. BioFlo™ Catheter Study demonstrated equivalent thrombus accumulation on the external catheter surface based on visual examination*.

The ChronoFlex™ Catheter demonstrated minimal to non-existent thrombus formation.

BD’s ChronoFlex™ Catheter

AngioDynamics’ BioFlo™ Catheter

Groshong Distal Valved Port Catheter Study

The purpose of the Groshong™ Distal Valved Port Catheter study was to conduct a retrospective, multi-center data review to evaluate the maintenance flushing interval for patients using the Groshong™ Distal Valved Port catheter from BD.

The Groshong™ Distal Valved Port Catheter study demonstrated that a 90-day saline-only maintenance flush interval for Groshong™ Port Catheters is acceptable. Maintenance flushing of Groshong™ Port Catheter systems demonstrated very low adverse event rates in the retrospective data which challenges the classic 28-day maintenance flushing procedure.

Psychologist doctor discussing with patient

Recommendation to extend maintenance flushing schedule from its current interval of every 28 days to every 90 days on the collected saline-only data.

C.R. Bard/BD sought, and received, FDA's permission to extend the flushing protocol for Groshong™ catheters from 28 days to 90 days.

*and a 1.75 margin of non-inferiority

1 McDonald MC III. Veins for Life Study: A retrospective multi-centered study to assess the complication rates of oncology patients accessed with peripheral intravenous lines and implantable ports for chemotherapy administration. BD; 2021

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PowerPort™ isp Implantable Ports are associated with
high patient satisfaction.^1,2

Two surveys* conducted to measure patient satisfaction and impact on daily life 90-days after port implantation reported that patients are highly satisfied with their PowerPort™ isp Implantable Ports.^1,2

Click below to hear our patient testimonials

Patient Testimonials

Patient Quality of life with Ports vs. other vascular access devices

Improved patient satisfaction

Higher degree of comfort 

Improved quality of life 

Delivering long-term maintenance therapies that prolong survival 

No visible external line 

Less pain

Less anxiety

Dr. Ripal Gandhi,
MD, FSVM, FSIR

My staff and I have used a wide range of ports in the past. Once we placed the PowerPort™ ClearVUE™ Implantable port and saw the metal free and power injectable features firsthand, it was a simple choice to continue using this port in my practice."

If I have a patient who is eligible for proton beam therapy to structures in the chest, I will only place a 100% metal free port so that therapy can be delivered without relocating the port. Since PowerPort™ ClearVUE™ is MR Safe, this allows my staff and I to place the device without concern about interference with future MR imaging.

Dr. Jon C. Davidson,
MD, FSIR

What truly sets PowerPort™ ClearVUE™ apart is its intentional design that considers the patient's future diagnostic and treatment needs. The device's 100% MRI safety enables seamless integration with cutting-edge MR therapies, including MR Linac, expanding treatment options and enhancing the quality of care we can provide to our patients.

* Two surveys were conducted to compare patients’ satisfaction and impact on daily life after port implantation. Data is from patients who were surveyed 90-days after their port implantation. Goltz et al., 2013 was a prospective study that surveyed 25 consecutive patients with chest-implanted ports who had an underlying malignancy with upcoming chemotherapy.1,2 All chest-implanted ports were PowerPort™ isp Implantable Ports, Bard Access Systems, Salt Lake City, Utah, USA. The questionnaire was developed by two of the authors and covered four topics: (a) information about and perception of the implantation procedure; (b) comfort of the port, influence on daily activities, cosmetic aspects, and existence of certain fears regarding device function; (c) history of device-related complications; and (d) overall satisfaction with the port device. Kunz-Virk et al., 2019 conducted a telephone interview to survey 89 patient’s (90% requiring the port for chemotherapy) subjective rating of the port.2 All ports were PowerPort™ isp Implantable Ports MR 6.0 French (Fr), Attachable Polyurethane Catheter, Bard Access Systems, Salt Lake City, Utah, USA. Patients were surveyed 90-days post implantation using a standardized questionnaire.1,2

1 Kunz-Virk J, Krüger K. Power-injectable totally implantable venous access devices - analysis of success and complication rates of ultrasound-guided implantation and a patient satisfaction survey. Vasa. 2019;48(6):524-530. doi:10.1012 /0301-1526/a000802

2 Goltz JP, Petritsch B, Kirchner J, Hahn D, Kickuth R. Percutaneous image-guided implantation of totally implantable venous access ports in the forearm or the chest? A patients’ point of view. Supportive Care in Cancer. 2013;21:505-510.

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The C.R. Bard/BD Port lawsuits – what are they about?

You may have seen ads or websites or heard from law firms alleging that C.R. Bard/BD Ports have manufacturing flaws that cause injuries to patients. Some law firms are claiming that there are FDA recalls for C.R. Bard/BD Ports because the catheters are fracturing, becoming occluded, or causing infections and thrombosis due to the barium sulfate in them. This litigation has received a lot of attention because of attorney advertising.

The fact is there have been no FDA-initiated recalls of C.R. Bard/BD Port Catheters related to catheter fracture, occlusion, thrombosis, or infection since C.R. Bard/BD port products first came to market in 1987.

The Facts

C.R. Bard/BD port catheters have been the #1 choice of clinicians for 35+ years

C.R. Bard/BD has sold hundreds of thousands of port products since 1987, which has helped countless patients through their treatment journeys. Our portfolio of C.R.Bard/BD PowerPort™ Devices have a long and successful history of enabling the treatment of critically ill patients, particularly those with cancer. As the market leader for ports, BD prides itself on patient safety and product quality.

There have been no FDA recalls for C.R. Bard/BD port catheters

Since 1987, there have been no FDA-initiated recalls on any C.R. Bard/BD ports related to catheter functionality. Some websites mistakenly claim that a 2022 recall was due to reports of catheter fracture, infection, and thrombosis, but it was not. C.R. Bard/BD recalled its PowerPort duo M.R.I. Implantable Ports in 2022 due to a manufacturing anomaly that impacted a limited number of lots. After discovering the issue, C.R. Bard/BD immediately initiated a voluntary recall of the affected lots and corrected the issue.

There have been no FDA warning letters issued for C.R. Bard/BD ports

The FDA has never issued a warning letter to Bard or BD regarding their line of port products. A FDA warning letter is an official message from the FDA to a manufacturer when they have violated a rule in a federally regulated activity. BD takes its commitment to safety very seriously – we actively monitor and investigate all reported complaints regarding our Bard PowerPort™ Devices and continue to report adverse events as required by the FDA.
*As of October 2024

There is no medical literature to support an increased rate of adverse events with C.R. Bard/BD Port catheters due to barium sulfate

C.R. Bard/BD has completed an extensive literature search to see if there was any research to support these lawsuit allegations. We came up empty handed. There is no existing clinical data that indicates an increased rate of negative side effects due to the use of barium sulfate in Bard Port catheters.

Many medical devices that are visible under x-ray imaging have barium sulfate in them

Any medical device that is visible under x-ray imaging likely has barium sulfate in it. Barium sulfate is used by BD and many other medical device manufacturers for this benefit.

Barium sulfate is commonly prescribed for patients to drink before they get abdominal imaging

Barium sulfate is a contrast agent that is commonly prescribed for oral consumption in order to diagnose problems with the gastrointestinal tract. Contrast agents are used to create a clear picture of the different parts of the body. The barium sulfate liquid or paste is often consumed just before a CT scan or x-ray.

C. R. Bard, Inc. and its subsidiaries were acquired by BD in 2017. Any mention or reference to “Bard” is now directly related to BD.

For more detailed information about the Bard Port Lawsuits, visit the official court website concerning the multidistrict litigation:

https://www.azd.uscourts.gov/re-bard-implanted-port-catheter-products-liability-litigation

For more information on FDA guidance concerning efforts to counter internet-based misinformation:

https://www.fda.gov/media/179827/download

Whom should I talk to about my concerns?

BD offers 24/7 support through our Medical Information Team:

Email: Medical.information@bd.com
Phone: 1-800-555-7422, ext 3
Normal hours are Mon – Fri, 8:30am-5:30pm EST
On call for emergencies 24/7, 365 days/year

Press Releases from BD Regarding Litigation

English

Press Releases from BD Regarding Litigation

English

*Recall was voluntary and triggered by BD quality management system. Zero FDA ordered recalls since 1987 (as of August 2024)

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true

The Facts on Power Injectable Implantable Ports

37 years on the market with the launch of our first Non-Power Port in 1987 and first power port in 2006.

What is a Port?

Why did your doctor recommend a port?

Why might you consider a port?

Risks associated with having a port

Types Of Ports?

Port Evolution

Anatomy of a Port

How It Works

Port Catheters

Barium Sulfate

All C.R. Bard/BD port catheters contain barium sulfate, which allows the catheter to show up under x-ray imaging. This helps your healthcare provider place your port correctly, which is crucial to your port working properly during your treatment.

BD® offers a wide range of ports and kit configurations to meet the needs of patients, port placers, and nurses.

Our Premium BD® Port Offerings

PowerPort™ ClearVUE™ Implantable Port

PowerFlow™ Implantable Apheresis IV Port

Port Access

BD® Studies on Port Catheters

The Veins for Life Study

The BD ChronoFlex™ Catheter vs. AngioDynamics BioFlo™ Catheter In-Vivo Thrombogenicity Study

The BD Groshong™ Distal Valved Port Catheter Study

VEINS FOR LIFE study

ChronoFlex™ vs. BioFlo™ Catheters In-Vivo Thrombogenicity Study

BD’s ChronoFlex™ Catheter​

AngioDynamics’ BioFlo™ Catheter​

Groshong Distal Valved Port Catheter​ Study

PowerPort™ isp Implantable Ports are associated with high patient satisfaction.1,2

Click below to hear our patient testimonials

The C.R. Bard/BD Port lawsuits – what are they about?

The Facts

BD^® offers a wide range of ports and kit configurations to meet the needs of patients, port placers, and nurses.

Our Premium
BD^® Port Offerings

PowerPort™ ClearVUE™
Implantable Port

PowerFlow™ Implantable
Apheresis IV Port

BD^® Studies on Port Catheters

BD’s ChronoFlex™ Catheter

AngioDynamics’ BioFlo™ Catheter

Groshong Distal Valved Port Catheter Study

PowerPort™ isp Implantable Ports are associated with
high patient satisfaction.^1,2