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Physiomesh

Physiomesh Causes Chronic Pain

“It is not the culture of U.S. medicine to report adverse events to the FDA.”

Dr. David Kessler, Former FDA Commissioner

Physiomesh Hernia Mesh Recalled by Ethicon

Physiomesh, an abdominal hernia mesh manufactured by Ethicon and Johnson & Johnson, was officially recalled from the global market in 2016 due to its high rate of severe complications. Prior to its recall, Physiomesh was fast-tracked through the FDA approval process according to an FDA 510(k) Premarket Notification. Due to this fact, it was not subjected to the necessary testing required to uncover now commonly agreed upon product flaws.

Men and women across the globe have fallen victim to the life-threatening complications of Physiomesh. In reaction, cases are currently being consolidated nationwide as devastated patients seek financial compensation for their losses.

Physiomesh & Ventral Hernia Repair Complications

Physiomesh is used to treat ventral hernias which occur when a bulge of tissue pushes through weakened muscles in your abdominal wall. There are about 500,000 ventral hernia repair surgeries that take place each year and it is estimated that about 330,000 have been repaired using Physiomesh since 2010.

Physiomesh is constructed from a dangerous substance called propylene that adheres to tissue and can cause erosion and organ perforation (as opposed to biologic mesh which absorbs into the body and strengthens the muscle structure naturally). In order to avoid complications from propylene, the manufacturer, Ethicon, created Physiomesh with a thick coating. This coating causes the device to slide around inside the body and eventually dissolves, exposing the propylene which can greatly damage internal tissue. Additionally, Physiomesh’s “flexible composite” has less elasticity than its competitors causing poor attachment to tissue which could lead to contraction, ripping of tissue and recurrent hernias.

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Physiomesh: Everything You Need to Know

Physiomesh: Everything You Need to Know

This recalled hernia mesh video walks you through the history of physiomesh and what went wrong. If you or someone you know has Ethicon mesh inside them this video is for you!

Video: Physiomesh – An Overview

Watch this video to learn the who, what, where, when of physiomesh. With any medical drug or device it is always better to know too much than be left in the dark without any information.

Video: The History of Physiomesh

When was hernia mesh recalled? Why was it recalled? Is it hernia surgery really unsafe? This recalled hernia mesh video answers these questions and more.

Ventral Hernia Mesh Complications Symptoms

Here are some common adverse effects that you or a loved one might be experiencing from complications due to a Physiomesh implant:

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Hernia Recurrence

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Revision/ Corrective Surgery

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Erosion/ Adhesion

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Migration to Other Organs

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Perforation of Other Organs

Physiomesh Lawsuits & Hernia Mesh Settlement Landscape

Regardless of where you live in the United States, if you (or a family member) have suffered from a defective Physiomesh, you may be a candidate to receive a settlement for the pain and suffering that you have endured. Currently, the number of Physiomesh cases filed continue to grow. In fact, you may have heard that Physiomesh will have a “mass tort” lawsuit. This means that if there are a large number of plaintiffs that have similar complaints against a product or device and they are joining together to make a claim against the company that sold it. To help with medical costs or the financial expenses of the pain and suffering incurred, patients are seeking compensation from the manufacturer through these upcoming mass tort settlements.

So far there haven’t been any settlements concerning Ethicon Physiomesh. However, as more and more people are coming out with complaints against Ethicon’s Hernia Mesh Product, this is bringing public attention to this case and allowing more people with Physiomesh problems the confidence to share their stories.

Florida Woman Files Suit Against Ethicon & Johnson & Johnson

On December 27, 2016, Sarah Ann Gilman filed a complaint in the US District Court for the Middle District of Florida, claiming Ethicon Physiomesh was defectively designed. Gilman had to undergo revision surgery due to an abdominal bulge, return of the hernia and severe pain which occurred when surrounding organs were damaged by the exposed hernia mesh.

Matthew Huff Trial Scheduled for January, 2018

Matthew Huff filed the first major lawsuit against Ethicon when he developed severe and permanent injuries after being implanted with a Physiomesh. He had to have revision surgery to remove infected tissue in 2013. Huff’s case is the first to go to trial and is scheduled for January, 2018. “The product, Ethicon Physiomesh Composite Mesh, was defective, unreasonably dangerous, and not suitable for implantation in Matthew Huff,” the lawsuits states. “Huff has suffered severe and serious problems and complications…caused by the product.

Georgia Man Files Suit After Facing Severe Intestinal Problems

Henry Lee Brown had a hernia patch which subsequently failed and eroded into his intestines. This resulted in the need for invasive surgery to remove the Physiomesh. The complications required the surgical resectioning of Brown’s small bowel to remove adhesions.

Even After Repair Surgery, Texas Woman Faces Chronic Abdominal Pain

Lizzey Annett of Texas underwent hernia surgery in July 2014. After the surgery, she noticed an enlarging bulge that turned out to be a recurrent hernia. In February 2015, she had another hernia surgery involving a 15cm by 20cm Physiomesh patch that also failed. During a third surgery in October 2016, the doctors noticed that the Physiomesh had caused small cuts to Annett’s bowel. The surgeon had to perform two small bowel resections to repair the damage.

Physiomesh Glossary of Key Terms

Hernia

A condition where an organ or fatty tissue pushes through surrounding muscles or connective tissue.

Hernia Mesh

A screen-like material that is applied to the muscle perforation to prevent the organ or tissue from pushing through.

Hernia Recurrence

If a hernia repair fails, the tissue is able to push through the muscle again.

Mesh Erosion

When the mesh breaks apart and can dangerously move to surrounding tissue and organs.

Mesh Migration

When an implant fails to attach to tissue, it can move around possibly causing damage to organs and surrounding tissue.

Organ Perforation

Surrounding organs are damaged due to an artificial implant that is out of place.

Ventral Hernia

At the site of a previous surgery, the muscle wall weakens due to an incision and makes it easier for the intestine to push through. (also called an “incisional hernia”).

Health & Wellness Resources for Physiomesh

GET YOUR FREE PHYSIOMESH CASE REVIEW TODAY

If you have had a Physiomesh implant, then these stories might sound familiar to you. No one should have to endure the pain and suffering of a device that was not fully tested. Maybe you have medical bills that are piling up or your pain has hindered your ability to work. Whatever your circumstances, Periscope Group wants to listen to you. We can help you to determine if you have a case to get the compensation that is owed to you.

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How to File for Financial Settlement After Injury from an Unsafe Drug or Device

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

The Link Between Medical Implants and Autoimmune Diseases

Fatigue. Brain fog. Fibromyalgia. Most people don’t associate these symptoms with having a medical device, but doctors and researchers have been finding a very strong link between the two. From patients who have breast implants to those with surgical mesh or knee replacements, countless people are struggling to battle autoimmune diseases resulting from their implants and yet have no idea why they’re feeling so sick.

The Link Between Medical Implants and Autoimmune Diseases

Types of Autoimmune Diseases

An autoimmune disease is when the body attacks and damages its own tissues. An autoimmune disease can be associated with materials used in medical implants, devices, and adjuvants (substances added to vaccines such as aluminum and mercury). Here are just a few of the common types of autoimmune diseases that have been linked to medical implants:

  • Chronic Fatigue Syndrome (CFS) – This condition can also be called systemic exertion intolerance disease (SEID) or myalgic encephalomyelitis (ME). Loss of memory or concentration, unexplained muscle or joint pain, headaches, and unrefreshing sleep are characteristics of CFS.
  • Fibromyalgia – Pain, stiffness, tenderness, and soreness in the muscles at “trigger points”.
  • Multiple sclerosis – A disabling disease of the central nervous system that disrupts the flow of information within the brain and between the brain and body.
  • Rheumatoid arthritis – An inflammatory condition that results in warm, swollen, and painful joints
  • Systemic lupus – The body’s immune system starts to attack healthy tissue and may cause  painful and swollen joints, fever, chest pain, hair loss, and more.
  • Crohn’s Disease – This inflammatory bowel disease can affect any part of the gastrointestinal tract from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea, fever, and weight loss.

Types of Medical Implant Materials

Depending on the injury or treatment needed, there are many different types of materials used.

Biologic

Biologic material is derived from living tissue, which can include intestines or skin that has been processed and disinfected for use as an implant device (for example, pig skin has been used instead of plastic mesh to reinforce hernias). The tissue is sourced from pigs, cows, sheep or humans. The most important specification for a biological material is that it’s biocompatible which means that it’s able to integrate into a host without causing an immune reaction. The pros are that they are more compatible with your body. The cons include that they can break down and degenerate.

Let’s say you had breast cancer and you wish to reconstruct your breast using your own tissue. A surgeon would take tissue from your stomach, thighs or buttocks to rebuild your breast instead of using saline or silicone which have been linked to cancers and other health conditions.

Synthetic

Obviously “synthetic” is something that doesn’t occur naturally and synthetic devices can include plastics, ceramics, porcelain, and other man-made materials. These are commonly used for dental implants, sutures, hernias, and more. Ceramics are even being used in joint replacements to “reinforce it and provide improvements to the bicompatibility, joint wear and mechanical properties,” explains researcher Ana Maria Arizmendi Morquecho. The pros are that synthetic materials can be cheaper, more readily accessible, and last longer than biologics. The cons are that they can cause autoimmune disorders in the body and many times the products aren’t fully tested before being put on the market. Transvaginal mesh (TVM) is one example that left countless women worldwide with multiple health complications that cannot be resolved. TVM is made out of a plastic called polypropylene that can erode in the body, migrate, and the sharp edges can sever tissues and organs.

Metal

Metals are commonly used in implants and titanium and metal alloys are often found in hip replacements and other similar implants. These products are many times used in combination with synthetic materials to mimic bone and tissue function. While they are long lasting, many people experience autoimmune disorders since the immune system may fight a foreign object in the body. Essure was a popular permanent birth control device that was designed to be implanted in the fallopian tubes. It was made out of 55% nickel. The problem is that 20% of women are allergic to nickel and had serious reactions due to this device.

How the Body May Respond to an Implant

Medical implants can be made from a variety of materials depending on the injury or issue it is supposed to address. However, each person can react differently to each material. Here are some recent studies linking autoimmune diseases with common medical implants:

Breast Implants

In January 2019, a study was published in Clinical Rheumatology that stated that silicone may trigger immune responses that increase the risk of developing fibromyalgia and CFS. “Researchers studied 30 female patients, 47.9 years old on average, treated between 2000 and 2017, who received silicone breast implants before being diagnosed with a rheumatological condition,” explained Fibromyalgia News Today. “Overall, six patients were diagnosed with fibromyalgia, three with chronic fatigue syndrome, and 12 with depression; the remaining patients were diagnosed with other conditions, such as Sjögren’s syndrome and rheumatoid arthritis.”

Transvaginal Mesh (TVM)

Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta, noticed that many of his patients were experiencing the same health problems after having vaginal mesh surgery. “In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as ‘brain fog, muscle and joint pain ‘fibromyalgia, feverish temperature, and dry eyes and dry mouth,” Tervaert said. “Of those patients, 45% developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”

Essure

Essure was introduced to the market in 2002 and was supposed to be a permanent, drug free birth control device for women. This coil-like implant was placed in the fallopian tubes so that eggs cannot descend from the ovaries into the uterus to be fertilized. However, Essure is made out of 55% nickel and 20% of women are allergic to this metal. According to the FDA, “From 2002 through 2017, the most frequently-reported patient problems were pain/abdominal pain (21,215), heavier menses/menstrual irregularities (9,846), headache (7,231), fatigue (5,842), and weight fluctuations (4,970). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient-device incompatibility example, possible nickel allergy (4,481), migration of the device or device component (2,936), dislodged or dislocated device (1,356), device breakage (1,044), device operating differently than expected (947), device difficult to remove (331), device difficult to insert (317), and malposition of the device (279).”

What You Need to Know About Medical Implants

One of the biggest problems with medical implants is that patients don’t know that they’re linked to autoimmune disorders. After all, how can a hip replacement cause brain fog? However, there IS a strong connection between the two and patients need to know the symptoms to look for to determine if they’re having a negative reaction to their medical device. While the implant or device may not always be able to removed or replaced, having some answers may help you to address the symptoms more effectively.

 

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Sources
“Mesh devices may be to blame for autoimmune symptoms” Medical Plastics News. Accessed March 1, 2019. https://www.medicalplasticsnews.com/news/medical-devices/mesh-devices-may-be-to-blame-for-autoimmune-symptoms/?fbclid=IwAR2fl6djkplrWEM3YqrzkHf2_Ob0vy2mqHoViraEh71P5jXNMLoByx2SoqU
“Chronic fatigue syndrome”. Mayo Clinic. Accessed March 7, 2019. https://www.mayoclinic.org/diseases-conditions/chronic-fatigue-syndrome/symptoms-causes/syc-20360490
“Silicone Breast Implants Tied to Fibromyalgia, But More Evidence Needed, Study Says”. Fibromyalgia News Today. Accessed March 7, 2019. https://fibromyalgianewstoday.com/2019/02/13/silicone-breast-implants-fibromyalgia-more-evidence-needed/
“FDA Activities: Essure”. FDA. Accessed March 11, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm#s5
“Biological Materials Information”. Engineering 360. Accessed March 13, 2019. https://www.globalspec.com/learnmore/specialized_industrial_products/pharmaceutical_biotechnology/biotechnology/biological_materials
“Scientist look for nanostructures that allow compatibility between metal, human bone tissues”. Nanowerk. Accessed March 14, 2019. https://www.nanowerk.com/nanotechnology-news/newsid=38577.php

Do You Have an IVC Filter? Here’s What’s Happening in the News

This month IVC (interior vena cava) filters have been in the news quite a bit lately as lawsuits are settling and more claims are being filed. If you or a loved one has an IVC filter, here are the important updates that you should know about this controversial medical device.

Do You Have an IVC Filter? Here's What's Happening in the News

The Problems Linked to IVC Filters

For those who are at risk for blood clots and are unable to take blood thinners, IVC filters are placed in a large vein called the interior vena cava. The filter is made up of several metal prongs that connect at one end (almost like the frame of a closed umbrella). The hope is that the device will catch any blood clots and prevent them from traveling to the heart or lungs where it could cause extensive damage or even death.

The problem with the filter is that reports have been made to the FDA stating that the device can move causing it to puncture the interior vena cava. This device may also have prongs break off causing the pieces to migrate to other parts of the body creating excruciating pain and putting patient health at risk.

Lawsuit Finds in Favor of Patient with IVC Filter

Just last month an Indiana woman went to trial and won her case against IVC filter manufacturer Cook Medical. 53-year-old Tonya Brand of Snellville, Georgia, had an IVC filter surgery in 2009 and in 2011, a prong from her filter had migrated and pushed through the vein and the skin of her thigh. Other parts had also broken off and migrated throughout her body but are unfortunately unable to be removed. After deliberating for 11 hours, the jury decided that Brand should receive $3 million to help pay for the financial hardships that her injuries have caused.

This is a landmark verdict for patients who have had similar problems with their IVC filters; this is the first case where it was decided that this kind of device has a defective design. This is also the highest monetary compensation that has been awarded for this type of case (a Texas state court jury awarded $1.2 million against Cook Medical in a failure to warn case in 2018).

Upcoming Case to Watch

The newest and most notable lawsuit concerning IVC filter injuries was filed on February 26, 2019 in the U.S. District Court for the District of Arizona. This case is said to involve a woman from Missouri who was injured by the G2® Vena Cava Filter (“IVC Filter”) manufactured by C.R. Bard and Bard Peripheral Vascular, Inc. The crux of this case is based on the issue that C.R. Bard sold a defective medical device and failed to warn about safety risks. Currently, there are 6,300 actions pending in this case. This means that instead of taking each filed lawsuit to trial, the verdict of this case will help to determine the outcome and compensation of the thousands of similar cases brought against C.R. Bard.

Should You File a Claim?

There are now over 9,000 IVC filter lawsuits pending against IVC filter manufacturers Johnson & Johnson, Cook Medical, Cordis Corporation, Rex Medical, C.R. Bard, B. Braun and more. Clearly, hundreds of thousands of people had their lives put in jeopardy and thousands suffered from the terrifying effects of their broken filters. Profits were put before people and if you were injured, you should consider filing a claim to receive financial compensation due to high medical bills, lost wages, and other monetary hardships that you had to endure.

If you had an IVC filter placed in your body between 2005 – 2017 and had it break or migrate, call Periscope Group today at (800) 511-3838. We want to hear your story.

 

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Sources
“Indiana Jury Awards $3M in IVC Filter Lawsuit”. Legal Scoops. Accessed March 13, 2019. https://www.legalscoops.com/indiana-jury-awards-3m-in-ivc-filter-lawsuit/
“Indiana Jury Awards $3M in Cook IVC Filter Bellwether Trial”. Yahoo! Finance.  Accessed March 13, 2019. https://finance.yahoo.com/news/indiana-jury-awards-3m-cook-040408228.html

 

Study Finds 45% of Mesh Implant Patients Develop Autoimmune Disorders

Surgical mesh is often used in hernia repairs and in American women for stress urinary incontinence and pelvic organ prolapse (it’s illegal in other countries to treat gynecological issues). These medical devices have been linked to complications due to mesh erosion which can cause migration, organ perforation, bleeding, and other serious issues. A new study was recently published that also linked surgical mesh to a high rate of autoimmune disorders. If you have surgical mesh or are considering a procedure that uses a medical device implant, here is the information that you need to know.

Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta, closely monitored his patients and came to a shocking conclusion, “In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as ‘brain fog,’ muscle and joint pain ‘fibromyalgia,’ feverish temperature, and dry eyes and dry mouth,” stated Dr. Cohen Tervaert. “Of those patients, 45 per cent developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”

The Problem with Medical Device Implants

Unfortunately, complications can arise when any foreign object is inserted into the body. Similar symptoms have been frequently reported in patients who have silicone breast implants. “When a foreign body is put into the body, there is an instant activation of the immune system. It continues to fight the foreign body and eventually, over time, fatigues and becomes dysfunctional,” Dr. Cohen Tervaert explains. “Large-scale studies have shown that patients with breast implants have more symptoms of ASIA (autoimmune/auto-inflammatory syndrome induced by adjuvants) and an increased risk to develop an autoimmune disorder.

Doctors have determined that patients are genetically determined whether or not they’ll have an adverse autoimmune reaction to their medical device. Dr. Cohen Tervaert found that pre-existing allergies were present in 80% of breast implant patients which just so happened to be the same percentage of patients who had allergies in his patient group involving mesh. While it seems like an obvious answer is to have patients genetically tested for allergies before having a medical device implanted, unfortunately a test like this does not yet exist.

Many patients recovered after having the medical device removed in situations involving breast implants, but this type of surgery is more complicated with surgical mesh. Tissue and nerves can grow in and around the mesh making it virtually impossible to take out the entire device for countless patients.

Discussing your concerns with your doctor and carefully weighing the risks versus the benefits are two ways to protect your health. Also, familiarize yourself with the symptoms associated with autoimmune disorders. The sooner you call your doctor to address these issues, the better chance you have at recovery.

 

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Sources
“Surgical mesh implants may cause autoimmune disorders”. Medical Xpress. Accessed December 20, 2018. https://medicalxpress.com/news/2018-07-surgical-mesh-implants-autoimmune-disorders.html?fbclid=IwAR0cIcQsQyMQBaTwBCdv5q-kExUEkzteXXX9q9cDVby4VyOTHgcvbgF3qH8

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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