The use of shunts to treat hydrocephalus has been existing for more than fifty years. These devices allow excess cerebrospinal fluid to drain to other areas of the body. The extra fluid is then drained to a different body area where it can be absorbed quickly.
Despite the successful use of these devices, there has been recent complications and recalls involved with them. The most recent one involves Medtronic valves reported to have failed to drain brain fluid fast enough. These have resulted in excessive brain fluid buildup, causing severe complications like lethargy, coma, and death.
If you or your loved one has been affected by these valves, you should hire a professional attorney who can help you file a mass tort lawsuit against the responsible party. Contact the Consumers Alert Now for a detailed review of your case and let us help you in the best possible way.
Understanding Brain Shunt Valves, How they Work and What They Treat
Shunt valves or ventriculoperitoneal shunt is a medical device used by doctors to treat a brain condition called hydrocephalus. The purpose of these shunts is to remove excess cerebrospinal fluid from a patient’s brain. If the fluid builds up, it increases your brain’s pressure, and this can be potentially harmful. Using a brain shunt will drain the excess cerebrospinal fluid to reduce the pressure and put it safely.
Brain shunts have two tubes and two valves. The tubes are referred to as catheters, which drain the fluid. One of the catheters, known as the inflow catheter, drains the cerebrospinal fluid through a small hole. The other one, referred to as the outflow catheter, runs under the patient’s skin to take the fluid to a different body area.
The valve, also known as the pump, controls the shunts to ensure that it draws the fluid.
There are two kinds of brain shunts. These include the programmable and non-programmable types. The programmable shunt has an externally adjustable valve used by the doctor to readjust them anytime according to their user's needs.
On the other hand, the non-programmable shunt has a default program that activates the valve when the cerebrospinal fluid reaches a specific volume. Adjusting this shunt is impossible once it has been inserted.
Uses of the Brain Shunt
Doctors rely on brain shunt to treat hydrocephalus. Hydrocephalus is a condition that involves the pooling of cerebrospinal fluid in a person's brain cavity. Cerebrospinal is responsible for delivering necessary nutrients to the brain and draining away its waste. The cerebrospinal fluid passes through the ventricles and drains at the base of the brain, where the blood reabsorbs it.
Detailed Information About Hydrocephalus
Hydrocephalus is the building up of fluid in the ventricles deep within the brain. The excess fluid increases the ventricles' size and puts pressure on the brain. Naturally, cerebrospinal fluid flows through the ventricles, but when someone has hydrocephalus, there might be extreme brain tissue damage, causing a range of brain-related impairments.
Hydrocephalus occurs at any age, but it is frequent among infants and adults 60 years and over. Surgical treatment and insertion of brain shunts can restore cerebrospinal fluid's average level in the brain. Patients also require to go through different therapies to manage symptoms or functional impairment that result from hydrocephalus.
Causes of Hydrocephalus
The causes of hydrocephalus are poorly understood. Most people think that hydrocephalus present at birth may result from a brain defect that restricts cerebrospinal fluid flow. In adults, this condition is caused by an illness or an injury that affects the brain. This condition might result from an infection, an injury, or disease for older people, but it is not entirely clear what causes it.
Here is a detailed view of the causes of the condition in different age groups.
Hydrocephalus from Birth
Certain health conditions like spina bifida can cause hydrocephalus present at birth or congenital hydrocephalus. It can also develop in babies born prematurely born before the 37th week of pregnancy. Some premature babies bleed in the brain, which can end up blocking the flow of cerebrospinal fluid, leading to hydrocephalus.
Other potential causes of congenital hydrocephalus include:
- A rare genetic disorder like Dandy-Walker malformation
- Mutation of the X-chromosome
- Arachnoid cyst – This are fluid-filled sacs located between the brain, spinal cord, and the arachnoid membrane
Hydrocephalus that Develops in Children and Adults
Hydrocephalus in children and adults (usually referred to as acquired hydrocephalus) results from an injury or illness. The potential cause of acquired hydrocephalus includes:
- Bleeding inside of the brain
- Brain blood clots
- Brain tumors
- Head injury
Some people born with narrowed brain passageways that restrict cerebrospinal fluid do not show any symptoms until years later.
Hydrocephalus in Old People
People aged 60 years and above can sometimes experience hydrocephalus after a brain injury, infection, or bleeding. They usually experience a different type of hydrocephalus known as the average pressure hydrocephalus (NPH). It is thought that NPH is linked with other underlying health conditions that affect normal blood flow, such as diabetes, high cholesterol levels in the blood, and heart disease.
Symptoms of Hydrocephalus
The signs and symptoms of hydrocephalus vary by the age of onset. Let's have a closer look at these symptoms based on the age of the affected people.
Symptoms in Infants
Infants with hydrocephalus might experience a change in their head through an unusually large head, a rapid increase in their head size, and a bulging and soft spot on the top of the head.
When it comes to the physical signs and symptoms exhibited on infants, these include:
- Poor feeding
- Poor feeding
- Poor growth
- Fixing their eyes downwards or sun-setting their eyes
- Poor response to touch
- A deficit in muscle strength and tone
Symptoms in Toddlers and Older Kids
Among older children and toddlers, the potential physical signs and symptoms of hydrocephalus include:
- Blurred or double vision
- Nausea or vomiting
- Sleepiness or lethargy
- Abnormal enlargement of the toddler's head
- Poor coordination
- Poor appetite
- Urinary incontinence
- Poor appetite
- Abnormal enlargement of the toddler's head
Apart from the physical signs and symptoms, older kids or toddlers might experience several behavioral and cognitive change, such as:
- A decline in school performance
- Change in personality
- Delays or problem with previously acquired skilled like talking and walking
Symptoms in Young and Middle-aged Adults
Among young and middle-aged adults, the typical type of symptoms that they might experience include:
- Loss of coordination and balance
- Loss of bladder control
- Impaired vision
- A decline in concentration, memory, and other thinking skills that affects the performance of job
Symptoms in Older People
For older adults aged 60 and above, the common signs and symptoms of hydrocephalus are:
- Memory loss
- Loss of bladder control or frequent urge to urinate
- Poor balance or coordination
- A progressive loss of thinking and reasoning skills
- Difficulty in walking often described as shuffling gait
When You Should See a Doctor
You should seek emergency medical care for toddlers and infants if they experience the following signs and symptoms:
- Problem sucking or feeding
- Unwillingness to lay down or move their head
- Breathing difficulties
- High-pitched cry
You should promptly seek medical attention for other signs and symptoms in different age groups since more than one condition can result in this condition's problems.
Complications of Hydrocephalus
A long-term complication of hydrocephalus varies widely and is usually difficult to predict. If hydrocephalus progresses for a long time of birth, it may cause significant intellectual developmental and physical disabilities. There might be few or no severe complications in less severe cases if the condition is treated appropriately.
Adults experiencing a significant decline in their memory or other thinking skills usually have lower recovery and persistent symptoms after treating this condition.
The severity of the complication depends on the severity of the initial symptoms, timeliness of diagnosis and treatment, and underlying developmental problems.
Diagnosis of Hydrocephalus
Hydrocephalus is diagnosed using CT and MRI scans. These scans are often used in combination to confirm a positive diagnosis of both congenital and acquired hydrocephalus. These two types of diagnosis scan the brain in detail and show the buildup of fluid in the brain and increased pressure. It also highlights any structural defects that may cause the problem.
Sometimes congenital hydrocephalus is detectable before birth during ultrasound scans.
Diagnosis of Normal Pressure Hydrocephalus
It is challenging to diagnose Normal Pressure Hydrocephalus (NHP) since some of its symptoms are similar to other common conditions like Alzheimer's disease. That's why it is necessary to make an accurate and correct diagnosis to be sure that it is not Alzheimer's disease but NHP.
Your doctor will assess whether you have NHP or Alzheimer's disease by evaluating your mental ability, how you walk, and symptoms like urinary incontinence. Your doctor can also determine whether you have NHP by scanning your brain.
Your doctor might also diagnose whether you have NHP if you have mental problems, walking problems, bladder problems, and when your cerebrospinal fluids levels are higher than usual. However, you may not exhibit all these symptoms at the same time.
Further tests needed to decide whether you have NHP or can benefit from surgery include lumbar puncture, drainage test, and infusion test. Let's have a closer look at these options.
A lumbar puncture is a procedure that involves taking a sample of the cerebrospinal fluid from the lower spine. Your doctor will then check the pressure of the CSF to determine whether you have the condition.
Removing CSF during a lumbar puncture can help improve your symptoms. If it does, you can benefit from the surgery.
Lumbar Drainage Test
You might also have a lumbar drain if a puncture does not improve your symptom. This procedure is done through local anesthesia and inserting a tube inside your vertebra to drain a large CSF amount. This process will be done for a few days to check whether the symptoms will improve.
Lumbar Infusion Test
In a lumbar infusion test, fluid is usually injected into the lower part of the spine while measuring its pressure. Ideally, your body should absorb extra fluid and maintain low pressure. If the body cannot absorb the excess fluid, your pressure will rise, indicating that you have NHP, and surgery would be helpful.
Treatment of Hydrocephalus
You should seek prompt treatment for babies with congenital hydrocephalus and older children who have acquired the condition. If it is not treated early, it might increase the pressure and cause brain damage. Both congenital and acquired hydrocephalus is treated using shunt surgery or neuroendoscopy.
Shunt surgery is the most common treatment used to treat this condition. During this process, a thin tube, referred to as a shunt, is implanted in the brain. The excess cerebrospinal fluid is then directed to another part of the body, usually the tummy. From here, it is absorbed into your blood.
These shunts usually have valves that control cerebrospinal flow to avoid the quick draining of the fluid. You can feel the valve as a lump under the skin on your scalp.
When it comes to inserting the shunts, a neurosurgeon should handle this process. The process is done under general anesthesia and usually takes one to two hours. Your doctor might advise you to stay in the hospital for a few days until you recover fully.
If you have stitches, they may need to be removed or allow them to dissolve. Some surgeons use skin staples to close the wound, which might need to be removed within a few days.
Once the shunt is installed, further treatment for the condition might be required if the shunt blocks or is infected. Shunt repair surgery would be necessary to some extent.
FDA Recalls Associated with Medtronic Brain Shunt
On 22nd February 2017, Medtronic, a company involved in brain shunt manufacturing, issued a voluntary recall of their StrataMR adjustable valves and shunt. These devices were manufactured and marketed by Medtronic's Neurosurgery businesses, which is part of the Brain Therapies division of the company's Restorative Therapies Group. The recall only applies to StrataMR adjustable valves and shunts and does not affect the Strata ™ or the Strata NSC products.
FDA considered this recall release a Class 1 recall, meaning that it is a severe type of recall, and the use of these defective devices can cause severe brain injuries or death. Specifically, the recall numbers include StrataMR Adjustable Valves and Shunts bearing the following device model numbers:
- 42955 for small valves, and 42965 for regular valves
- For the shunt assembly, small ones had 4699 as their model numbers, while regular ones bore 46965 as their model number
- For the Snap Shunt Assembly, small one had 46960 as their model number, while regular ones had 46970 as their model number
The manufacturing dates of these devices was from 27th October 2015 to 11th November 2016. Their distribution was made between 27th January to 21ST February 2017. According to Medtronic, about 2,6622 devices were affected as of the initiation of the recall.
Reasons for StrataMR Recall
As of 1st April 2017, StrataMR related complaint rate had increased by 2.75% (about 72 complaints) of the 2622 units distributed. This resulted from the devices' design problem that would cause their valves to open pressure higher than the specified levels and increase the cerebrospinal fluid flow resistance. If this occurred, it would trigger a potential under-drainage of the fluid. Underdrainage usually occurs when the cerebrospinal fluid is not quickly removed, which causes its buildup in the brain cavity, leading to adverse health consequences that include coma and death.
The potential symptoms for shunt malfunctioning include returning or failing to correct all the signs and symptoms explained above. Remember, these symptoms vary according to the age of the affected person. Therefore, you would expect them to be affected according to their age groups.
Only one death was reported and believed to be associated with these devices, but it is not clear whether it resulted from a malfunctioning StrataMR valve.
Medtronic's Issue Related to the Recall
As Medtronic was issuing its recall, it asked all its customers to:
- Discontinue using the StrataMR Adjustable Valves and Shunts
- Account for the implanted units and those that were discarded and return all the unused product by completing an individual customer product accountability form in Attachment A of the recall letter
- Return all unused units to Medtronic
Please note, Medtronic did not recommend the removal of StrataMR valves that had already been implanted. However, it provided instructions to neurosurgeons and neurologists on how to monitor existing patients with these valves.
What this Recall Meant to Medtronic Customers
Many Medtronic customers were left wondering what would happen to them after the recall. To start with, you should first determine whether the shunt at your disposal is programmable and its current setting. Most of the information related to your brain shunt is available on your Patient Shunt Card.
Secondly, if you have a programmable shunt, know that your shunt settings can change after an MRI procedure. Therefore, if you need to undergo an emergency procedure or MRI procedure, make sure that the settings are checked and verified by your neurologist or neurosurgeon.
Thirdly and lastly, beware of any changes associated with your current StrataMR valve. If you feel anything different, notify your neurologist or neurosurgeon.
Filling a Lawsuit Associated with The Effects of Malfunctioning StrataMR Adjustable Valve and Shunt
A patient harmed by a medical device like the StrataMR has the right to file a civil action or lawsuit and recover the damages caused by the faulty device. Damages can include present and future medical bills, lost wages, pain and suffering, and out-of-pocket medical expenses.
Medical device defects can occur during the design, manufacturing, or marketing phase. In the case involving StrataMR Adjustable valves and shunt, their defects occurred during the design phase hence their malfunctioning.
Winning a Medical Product Liability Case
Several legal elements are needed to prove a medical liability case against Medtronic due to their defective StataMR valves and shunts. These legal elements include:
- The company had a duty of care not to harm you
- The company breached its duty through negligence actions (failure to design their devices up to the required standards that ensure that they are safe to use)
- The company's negligence is a proximate cause of your injuries
- As a result of the injuries, you suffered compensable damages
Filling a Medical Product Liability Through a Mass Tort Lawsuit
Mass torts are types of lawsuits filed is a single wrongful action that causes injuries to a lot of people. The injured people can come together in a single mass tort lawsuit to seek justice for the various injustices against the defendant, possibly a well-established defendant like Medtronic.
There is no known mass tort lawsuit filed against Medtronic due to their defective devices. However, affected people can still file a mass tort lawsuit against Medtronic. Simultaneously, filing a mass tort can be challenging because it is unclear whether the reported death is entirely based on a defective StrataMR Adjustable Valve and Shunt. There are also no reports related to the effects of malfunctioning StrataMR, making it more challenging to file a mass tort lawsuit.
The best way to file for compensation from the at-fault party is filing an individual lawsuit. Filing a separate lawsuit against a company like Medtronic is quite challenging, but you can have yourself well-compensated once you hire the right attorney.
If you or your loved one has been adversely affected by the use of Medtronic Shunt Valves and Shunts, at Consumer Alert Now, we are more than happy to help you. We can answer all your questions and help you pursue your claim in an explicit and informed way.
Our attorneys will also help you in the best possible way to ensure that you are compensated for the damages incurred from the use of Medtronic’s StrataMR brain valves and shunts, wherever you are in the United States. Call us at 800-511-0747 and schedule an appointment with us.