Connect with us

Medical Devices

FDA Flags Surgical Staplers after Reports of Medical Malfunctions

mm

Published

on

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.

Comments
Continue Reading

Medical Devices

Hernia Mesh Defective Products Cause Lifelong Complications

Published

on

By

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

Event 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.

Comments
Continue Reading

Medical Devices

Complications from Hernia Mesh

mm

Published

on

hernia mesh

Hernia mesh products have been around and used in hernia repair surgeries since they were first introduced in the 1950s. However, they have not been without some serious complications, which can even be life-threatening. While there are risks for any hernia repair surgery, some of the most common and most serious have resulted from mesh products that have been recalled.

Adhesion from Hernia Mesh Products

One of the most common issues is adhesion from the mesh implanted in the abdomen of the patient. Hernia mesh products are made of a variety of materials, and they may attach to tissue inside. The mesh has a coating which helps prevent the issue, but the coating dissolves while the mesh is often permanent.

The mesh may adhere to the abdominal wall or the intestines or other tissue. It can cause severe pain that won’t go away until the product is removed through surgery. Adhesion can lead to bowel obstruction.

Bowel Obstruction with Hernia Mesh

A bowel obstruction begins with an adhesion to the intestines. It can also migrate where it can entrap the intestines. Symptoms of bowel obstruction include nausea and vomiting. The patient is also unable to pass stool. They will require immediate attention because this is a dangerous condition.

If not treated quickly enough, part of the intestine may need to be removed. Reports from the FDA cite mesh products that have been recalled as a major reason for obstruction.

How Hernia Mesh Causes Bowel Perforation

Recalled products have also been shown to cause perforation in the bowels. This occurs when the mesh punctures the intestine or other area of the abdomen. It may also puncture an organ, creating a life-threatening condition.

Symptoms of a bowel perforation include nausea and vomiting along with severe pain in the abdomen and rigidity of the abdomen – the abdomen feels hard. Bacteria can get into the abdomen from the puncture, which can then lead to sepsis and peritonitis. These conditions may be fatal.

Infection from Hernia Mesh

An infection may result from hernia mesh surgery. Often, the mesh will need to be removed through surgery. Antibiotics can treat minor issues while deep infections are more complicated. Chronic infection may not begin for years after the initial surgery, which can make it more difficult to diagnose.

A person with infection from a hernia mesh product may experience inflammation and fever. They may notice other flu-like symptoms as well.

Migration of the Hernia Mesh

Another complication for hernia mesh surgery is that the product will detach and migrate into other areas of the body. Complications from a migrating mesh can include the following:

  • Adhesion
  • Bowel obstruction
  • Bowel perforation
  • Abscess
  • Fistulas

In one case reported to the FDA, an implant detached and migrated to the intestine where it adhered. Surgery was required to remove the mesh along with a portion of the intestine.

There may be pain with migration or the patient may not have any symptoms until other damage occurs.

Damaged Mesh

The hernia mesh product may rip, tear or disintegrate, causing problems. The mesh can rip from the sutures, which often happens if the person lifts something too heavy or overexerts themselves too soon after surgery.

Another issue is if the mesh shrinks, which can cause it to come lose from the sutures in time. A long-term issue is when the mesh erodes and breaks into pieces. The pieces may move around and perforate surrounding tissue.

All of these problems can lead to migration, which can cause other complications. Surgery is often necessary to repair the condition.

Issues with hernia mesh can happen right after surgery, a few weeks or months later or years afterwards. The hernia may rupture again even with the mesh in place. While the product is effective at repairing the hernia, it is not a guarantee.

Defective Products

As with any surgical procedure, there is a risk of these complications even if everything is done correctly. However, there have been numerous recalls of hernia mesh products that increase the risk of problems. It may be related to the materials used or the design of the product. Some products have a higher failure rate than others, and some have been recalled due to their safety issues.

It is important to let a doctor know you’ve had a hernia mesh if you experience symptoms that can be associated with these complications. Often, immediate medical attention is necessary to prevent further damage or health issues. It can be difficult to diagnose a condition related to the mesh correctly.

Comments
Continue Reading

Medical Devices

Hernia Mesh Injuries Result in Lawsuits

mm

Published

on

Team of Surgeons Operating.

Many people who have had hernias needed surgery to fix the problem using a hernia mesh. These products come with side effects, including infection, adhesion and a reaction to the mesh. However, some products have a defective design which causes them to not function properly. When this is the case, the injury often turns into a lawsuit.

Defects in the Devices

When a lawsuit is filed, the attorneys for the plaintiffs argue that the devices were designed incorrectly or not tested to ensure safety. The main issues with the hernia mesh includes using the wrong material. The materials used often:

  • Migrate
  • Shrink or contract
  • Harden
  • Adhere
  • Fail

The results from a defective mesh can include damage to the bowels or abdominal wall, damage to other organs and nerve damage. Often additional surgeries are necessary to correct the problem.

Another issue with hernia mesh devices is they have been marketed for uses for which they aren’t necessary. For example, they may be used in small hernias that would otherwise use laparoscopic treatment or stitches.

The challenge of the court is to determine if the injuries that occurred would not have occurred with a substitute product or another treatment option.

Injuries and Side Effects from Hernia Mesh

When the hernia is located in the abdominal wall, surgery is often necessary to correct the condition. Smaller hernias in this area can often be repaired with a different material for the mesh or without the use of a mesh device.

Synthetic mesh products pose a higher risk than biologic devices, and many of these products are taken to market quickly through a clearance process by the Food and Drug Administration called 510K. Numerous devices have been recalled.

There are hidden results that many patients aren’t aware of. They include the following:

  • Coatings which are used on the mesh device and may cause a reaction in the patient or infection
  • The mesh shrinks or hardens
  • The mesh may detach and migrate to a different area
  • Reaction to a foreign body or rejection of the device

Common side effects for patients who receive a hernia mesh include:

  • Infections
  • Obstructions in the intestines
  • Adhesions to tissue
  • Permanent nerve damage
  • Recurrence of the hernia

Many times, the patient must undergo revision surgery to correct the resulting conditions and remove the mesh or replace it.

Risks of Using Hernia Mesh over Stitches

A hernia mesh is often used in surgery where stitches would work as well. The risk of choosing the mesh is the device can shrink or move over time. This situation can lead to perforations in the bowel or other organs as well as obstruction in the bowel. The risks increase if the device is faulty or if it uses polypropylene as a coating.

If the bowel is perforated, bacteria can seep into the bloodstream or other areas and cause sepsis, which can be a fatal disease.

Symptoms of complications from a hernia mesh include:

  • Fatigue
  • Fever
  • Irritable bowels
  • Constipation
  • Severe pain
  • Urinary problems
  • Nausea
  • Vomiting
  • Abdominal pain

Complications can occur immediately following the procedure or within a few days. They can also take years to show up when the mesh device falls apart or causes a problem.

While there is risk involved with hernia surgery and complications can arise, they are often increased with a defective device. The product should be labeled properly with the risks and warnings clearly stated.

Multiple Devices Recalled

Numerous mesh devices from different manufacturers have been recalled. For instance, Johnson & Johnson recalled the Physiomesh, manufactured by the subsidiary Ethicon. Studies revealed a higher rate for revision surgeries with the use of this device for minor hernia repairs.

Covidien is another manufacturer that has been involved in settlement discussions for its products. One issue was with the Parietex product, which used polyester as the material instead of polypropylene. Tests were not conducted to test the safety of the product before it went on the market.

Bard has also been involved in hernia mesh issues with the Sepramesh IP Composite product, which is used in deficiency of soft tissue. It has been associated with bowel obstruction and adhesions.

Atrium C-QUR is another device that was used in small hernia repairs but has had some issues. There are two products in this line. One was for pre-peritoneal hernias and the other was for intra-abdominal repairs.

Hernia mesh products have not always been effective and may even cause more problems than what they were intended to cure. Numerous patients have suffered pain and required multiple surgeries to fix the problem caused by defective products.

Comments
Continue Reading

Trending