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Medical Devices

FDA Flags Surgical Staplers after Reports of Medical Malfunctions




The U.S. Food and Drug Administration has just flagged a common medical device—surgical staplers and implantable staples—because of a heightened risk associated with their use in medical procedures.

The FDA issued its warning in a “Letter to Health Care Providers.” In it, the federal agency is alerting doctors and health care providers of an alarming increase in reports of malfunction when using surgical staplers and implantable surgical staplers. In its warning, the FDA also published recommendations for how manufacturers can improve the labeling of surgical staples and stapler devices to help health care providers use the devices more properly and effectively, such as choosing the correct size of staple for the type of procedure and patient tissue. The labeling recommendations also suggest that health care providers consider alternative options to surgical stapling in cases where the patient has a predisposition of bleeding or if the patient has swollen tissues.

The FDA also highlighted its own recommendations to help reduce the risks of these devices, and they outline the agency’s plans to address the safety of the devices over the coming months. These plans include creating a public advisory committee to analyze the path for medical device manufacturers to bring their surgical staples and staplers to market, and whether this current pathway has the appropriate safety and review checks.

Thousands of Reports of Device Malfunction.

The FDA’s warning reports that it has received more than 41,000 risk reports for surgical staplers and implantable staples since January 2011. These complaints, called “medical device reports,” include more than 90,000 serious injuries, more than 32,000 reports of device malfunction, and 366 patient deaths from using these devices.

The agency outlined the types of problems reported from surgical staplers and staples. The most common issues reported range from staplers misfiring and difficulty of firing staples, to malformation of staples and opening of the suture line after implantation. The complaints reported also included an issue with the staples being misapplied, or when the health care professional implants the staples into the incorrect tissue, as well as cases of using the wrong size of staple for the patient’s tissue.

The FDA states that these problems with the devices can have significant impacts on the health and safety of patients. Health risks include prolonged surgical procedures and risk of tearing of internal organs and tissues. The malfunction of surgical staplers and implantable staples have, in some cases, required additional, unplanned medical procedures; these, in turn, could lead to other medical complications including bleeding, tissue and organ tearing, increased risk of cancer, and even death.

And this is not the first time that the FDA has warned about the risks associated with surgical staplers and implantable staples. The FDA has been reviewing the risks of these devices for years and has issued previous communications about the potential risks of their use.

Prevalent Use of Surgical Staplers and Implantable Staples.

Surgical staplers and staples are widely used across many types of surgeries and medical procedures. These procedures range from gynecologic and gastrointestinal procedures, to procedures creating connections between organs and body tissues. Implantable staples and surgical staplers also facilitate resection procedures, or when surgeons remove part of a patient’s organ.

One benefit of surgical staplers and staples is a quicker operating time or the patient: the devices help make surgical procedure time quicker than it would be with traditional manual suturing. Implantable staples also have a lower risk of infection and maintain a strong wound closure to help support the patient’s recovery.

Quick Market Access for Device Manufacturers.

This warning letter from the FDA has highlighted the quick and easy access to the market that manufacturers of surgical staplers enjoy. Because these devices are categorized as only “Class I” medical devices, they do not require any regulatory submissions to the FDA before they can be sold on the market to health care professionals. This means that there is no mandatory FDA review and approval before these surgical staplers are used in medical procedures. (On the other hand, surgical staples are classified under the higher “Class II” of medical devices, and therefore they do require the FDA’s review before they can go to market.)

The Investigation is Ongoing.

In response to its new warning, the FDA emphasized that reporting potential health risks to the pubic is essential to the agency’s public health mission.  The chief medical officer of the FDA Center for Devices and Radiological Health said that the agency also plans to make its own process of addressing medical device risks more efficient, modernizing its procedures so that it can address device safety issues more quickly. This includes sharing information and analysis of medical device benefits and risks to both the public and to health care providers.

The FDA also emphasized that it is a top priority of the agency to improve the safety of surgical staplers and implantable staples. Meanwhile, its investigation into surgical staplers and staples is ongoing.


Defective Products

Hospitals Determining Repair or Replace for Faulty Infusion Pumps




Becton Dickinson, a manufacturer of infusion pumps, recently issued a recall for the Alaris infusion pump. This issue has left hospitals trying to determine if they should have the product repaired or replaced.

An infusion pump has the task of delivering medications intravenously, including pain meds and antibiotics. The pump also delivers blood to patients who need it. The device is used on patients of all ages, from infants to adults.

Dangers of Infusion Pump Malfunction

When an infusion pump malfunctions, it can deliver the medication too fast or not fast enough. If the medication is delivered too slowly, it may be ineffective at treating the condition. However, when medication is delivered too quickly, it can be fatal.
Hospitals must decide if they will repair the pumps by replacing as many as 7000 components on the device. The other option is to monitor the pump for defects. Many facilities are choosing to monitor the pumps since they haven’t had an issue with malfunctioning. Trinity Health is replacing the pumps at its hospitals around the country. Munson Healthcare is replacing half of the pumps but hasn’t decided on a product. Becton Dickinson products make up around 80 percent of the market for infusion pumps.

Other products do exist, including pumps from Johnson & Johnson, Coviden, Baxter, ICU Medical, B Braun and Hospira. The pumps range in size and can cost between $1000 and $3000 with some products even higher in price.

Numerous Recalls

The FDA labelled several recalls as Class 1, which means that the device could cause death or serious injury. Another recall received the label of Class 2, which may still cause harm to a person but the damage is temporary or can be reversed through medical means. Becton Dickinson responded by issuing voluntary recalls in February of 2020. At that time, over 1100 incidents had been reported with 55 injuries and one fatality. The recall affects multiple products in different series.

Products included in the recall date back to 2004 through 2019 to a total of 774,000 units that have been sold in the US. These devices may interrupt infusion, delay it, or have faster or slower delivery. Becton Dickinson has admitted that 13 models of the infusion pumps have had various problems with either the software or hardware. However, the manufacturer says the devices don’t necessarily need to be replaced or stop being used. Critics say that all the pump models included in the Class 1 recalls should be removed and destroyed.

The manufacturer’s instructions to hospitals gave the facilities the option to either removed and discard the pumps or to have them updated with new software and training for nurses. Some medical staff say they haven’t been taught how to use the devices with the new guidelines. Others say they have been given the information for monitoring these devices.
Hospital administration bear the burden of deciding how to respond to the recall to protect patients and manage the budget. Medical staff can only follow the requirements of their facilities and the guidelines of the manufacturer.

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Medical Devices

New Approved Treatment Becomes Available for Mesothelioma




Doctor team examining at lung radiograph x-ray film of patient in operation room.

A new treatment for patients diagnosed with mesothelioma has recently been approved by the FDA and is now available at the West Cancer Center in Memphis, TN. This is the first center in the nation to use electric therapy treatment for these patients.

An Exciting New Treatment

Electric therapy treatment works by sending electric fields into the body to target cancerous cells. The technician applies three pads to the front and back of the patient. Once the unit is turned on, electric fields are sent through the person’s body to disrupt the growth of the cancerous cells. At the same time, it leaves the healthy cells alone.

The new treatment promises to be popular because it’s not invasive. There are few side effects as well. The first patient has received the treatment, and they are wearing it for 18 hours each day. It is expected to have 97 percent control in the first year. If the patient uses the treatment along with chemotherapy, they may have a stable disease or positive response.

The device was first introduced in 2015 to treat brain tumors. It has since been used with ovarian and pancreatic cancer. It’s not being labeled as a cure, but it does help patients live longer. People diagnosed with mesothelioma normally have about two years life expectancy because this is an aggressive cancer. It’s rare, which makes research and treatment difficult.

Before the new treatment was approved, there were three options for treating mesothelioma, which included surgery, chemotherapy and radiation.

What is Mesothelioma?

Mesothelium is the tissue in the lining of your lungs, heart, stomach and other organs. Mesothelioma is a cancer of that tissue. It generally starts in the lungs, but it can begin in other organs as well. This condition has been linked to exposure to asbestos because the asbestos fibers get in the lungs when inhaled where they can’t disappear. Over time with constant exposure, more fibers get into the lungs. Symptoms of this disease often wait 20 or 30 years after exposure to show up. It starts with shortness of breath or pain in the chest. Fluid begins to accumulate, making it even more difficult to breathe.

Anyone who has been exposed to asbestos is at greater risk for developing mesothelioma. Even if you live with someone who works in the industry around asbestos can have an increased risk because they can inhale the fibers from that person’s clothing.

This type of cancer usually isn’t diagnosed until it’s advanced. The doctor will often order an X-ray of the chest or CT scan. If abnormalities are found, a biopsy may be ordered. After it has been analyzed, the results will tell if it is cancerous. Diagnosis could happen much more quickly if the person knows they were exposed to asbestos, but many people don’t think about these details of a job from 20 or 30 years ago.

Mesothelioma patients may find new hope with the treatment if it enhances the quality and quantity of their lives.

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Medical Devices

Hernia Mesh Defective Products Cause Lifelong Complications




Hernia mesh products have been around since the 1950s when they were first developed. They have become widely accepted as a method to repair hernias. Over time, manufacturers have altered these products with new materials, various coatings and unique features. Some of the mesh products have been proven to be defective, even to the point of causing life-changing injuries.

Multiple Defective Products

Even though hernia mesh products have been around for decades, new products are continually being introduced and not all of them are safe. Some of these products contain different materials and have not been tested thoroughly to determine safety. Often, additional surgery is required to remove the mesh and to repair the hernia again that the first mesh failed to treat.

Some of the products involved in lawsuits include the following:

  • Covidien – one of the most recognizable names, Covidien has had numerous claims against its products. Parietex hernia mesh was one product that used the material polyester rather than polypropylene. While it tried to fix the problems associated with this product, it did not test the safety of the mesh before putting it on the market.
  • Bard – another well-known name, Bard has a product called Sepramesh IP Composite, which is supposed to incorporate itself into the tissue and is made with polyglycolic acid and polypropylene. It is used in reconstructing soft tissue loss, but has been associated with serious side effects, including bowel obstruction and adhesions, which often require surgeries to correct.
  • Ethicon – the Ethicon Physiomesh was approved by the Food and Drug Administration (FDA) in April 2010 and launched as a product in October 2010. However, it was taken off the market voluntarily because of issues with the base layer, which is made of polypropylene. This plastic material is coated with polymeric films which is supposed to cause the material to degrade, but it often remains in the person’s body for a long time.
  • Atrium – The Atrium C-QUR was approved for use by the FDA in March 2006, but it has been associated with problems. Two versions, one used for pre-peritoneal repairs and another with placement in the intra-abdominal area, were designed for small hernia issues.

Complications from Hernia Mesh Products

Hernia mesh products can cause a wide range of side effects. The most minor include severe pain, but most require surgery to fix the problem. The most common complications from this product is also the most serious. Adhesion and bowel obstruction are common along with the risk of rejection, migration and infection.

One of the most common complications is adhesion which causes scar-like tissue to stick together and results in chronic pain that may be severe. It can lead to bowel obstruction which can be life-threatening.

In one case, a hernia mesh product attached to the small intestine of a patient. It was necessary to remove the mesh just 12 days after the original surgery to implant it. The mesh products are usually coated to prevent the risk of adhesion, but the coating is dissolved in the body in a short time, which then allows the product to adhere to the intestines or other tissue.

The mesh can also migrate to other areas of the body, where it can cause other issues. One of the most severe and dangerous complications is bowel obstruction. The person begins to feel nauseated and vomits and is unable to pass stool or even gas. Treatment is necessary immediately or the person can die. The obstruction will cut off blood flow if not treated quickly, which will allow part of the intestine to die and need to be removed. According to the FDA, a major reason for bowel obstruction is due to recalled mesh.

Bowel perforation is another serious condition which happens from hernia mesh. It occurs when the product punctures the bowel. The mesh can also perforate other organs or the abdominal wall. Symptoms include nausea and vomiting, severe pain in the abdomen and rigidity. Bacteria gets into the abdominal cavity and leads to peritonitis or sepsis and requires immediate medical attention.

These and other complications may occur right away after the initial surgery. However, it can also be years before a person experiences the complications. With the longer wait, it can take some time to realize the direct cause is the hernia mesh. Lawsuits have been filed for hernia mesh complications that resulted from recalled products or those that have been deemed to be defective. The cost of repair can be quite a financial burden with multiple surgeries and even permanent damage.

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