Preview Newsletter
Physiomesh Coverage
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(Netherlands) Field Safety Notice: Ethicon, ETHICON PHYSIOMESH™ Flexible Composite Mesh
May 30, 2016 | ArtsenApotheker
By Carrie Brodie-Meijer
ArtsenApotheker, a Dutch information news site for medical specialists, published a notice released by the Health Inspectorate, an independent health regulator of the Dutch healthcare system and a part of the Ministry of Health Welfare and Sport. The brief piece includes a link to the notice published on the regulator’s website, which includes a PDF of the letter regarding the voluntary recall of Physiomesh. -
(Italy) Johnson & Johnson International - PHYSIOMESH
May 31, 2017 | Italian Ministry of Health
Italian Ministry of Health’s posted a notification of the withdraw of Physiomesh from the market. The ministry’s warning included the PDF of the customer letter. -
(France) Lattice - Ethicon Physiomesh ™ Flexible Composite Mesh - Ethicon - Batch Recall
Jun 16, 2016 | Agence Nationale de Sécurité du Médicament et des Produits de Santé
The French health regulatory agency, Agence Nationale de Sécurité du Médicament et des Produits de Santé, published a notice on its website noting that it had been informed of the “implementation of the removal of a product by ETHICON.” The notice includes a link to the customer letter. -
(Australia) Hazard alert - higher rate of recurrence/reoperation
Jun 9, 2016 | Australian Department of Health
The Australian Government Department of Health posted a notice on its website noting the market withdrawal of PHYSIOMESH. The notice characterized the withdrawal as a ‘hazard alert’ and noted Johnson & Johnson is ‘recalling’ all unused stock of the device. Additionally, the notice referenced unpublished data from independent hernia registries in Germany and Denmark that allegedly shows that PHYSIOMESH has a higher average rate of recurrence than that of similar products. -
J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Jun 20, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh. -
Hernia Mesh Benefits Offset by Long-Term Risks
Oct 28, 2016 | Daily Hornet
Hernia mesh prevented hernias from re-opening and needing another surgery in “relatively few patients,” but caused much higher rates of long-term complications, according to a new study.. -
Johnson & Johnson's Ethicon sued over physiomesh product
Nov 11, 2016 | Florida Record
By Chandra Lye
A new lawsuit claims more patients have been having problems with medical mesh products. -
Ethicon Recalls Physiomesh Hernia Mesh in Europe, Australia
Dec 13, 2016 | Daily Hornet
By Elizabeth Bradley
Ethicon Inc., a subsidiary of Johnson & Johnson, stopped selling all Physiomesh™ Flexible Composite Hernia Mesh worldwide after a large study discovered a possible safety risk for patients. -
Lawsuits Scheduled for Ethicon’s Physiomesh Hernia Mesh
Oct 25, 2016 | Mesh Medical Device News
By Jane Akre
The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended. -
Ten Deaths Associated With J&J Physiomesh Hernia Mesh
Dec 15, 2016 | Mesh Medical Device News
By Jane Akre
At least 10 deaths and seven injuries, associated with PHYSIOMESH™ (JNJ) hernia mesh, have been reported to the U.S. Food and Drug Administration (FDA). Device Events worked with Mesh News Desk in preparation of this story. -
Ethicon Physiomesh Recall Issued Amid High Revision Rates
Jun 21, 2016 | AboutLawsuits.com
By Irvin Jackson
Johnson & Johnson’s Ethicon unit has issued a recall for a line of hernia repair mesh that has been linked to a high rate of problems and revisions, after the manufacturer failed to identify what is causing the problems. -
Ethicon Hernia Mesh Lawsuits Now Being Investigated By Southern Med Law Following Physiomesh Recall
Jul 8, 2016 | Southern Med Law
Southern Med Law, a law firm that represents the victims of defective medical devices, is now evaluating Ethicon hernia mesh lawsuits involving Ethicon, Inc.’s worldwide recall of Physiomesh Flexible Composite Mesh. Ethicon, a division of Johnson & Johnson, announced the Physiomesh recall via an Urgent Field Safety Notice issued to surgeons in May 2006. -
Physiomesh Lawsuit Information Webpage Looks To Inform Of Possible Hernia Mesh Failure
Aug 22, 2016 | Southern Med Law
Southern Med Law has launched a Physiomesh Lawsuit information page to provide Information to the public on Ethicon Inc.’s voluntary withdrawal of Ethicon Physiomesh Flexible Composite Mesh. The Johnson & Johnson subsidiary is removing its hernia mesh product from the worldwide market due to higher-than-average revision rates after use. Ethicon said it would no longer sell its Physiomesh Flexible Composite Mesh. Ethicon is also involved in litigation over its transvaginal mesh products which women allege causes organ perforation, chronic pain, mesh erosion, infection, scar tissue, and other injuries. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, U.S. District Court, Southern District of West Virginia) -
Ethicon Physiomesh Lawsuit Set for Trial in January 2018
Sep 16, 2016 | AboutLawsuits.com
By Irvin Jackson
One of the first lawsuits filed against Johnson & Johnson’s Ethicon subsidiary over problems with Physiomesh used for hernia repair, is slated to go before a jury in January 2018, as a growing number of individuals continue to pursue cases in the wake of a recall issued earlier this year, due to high failure rates. -
Lanham Blackwell & Baber Television Ad
Sep 19, 2016 | Lanham Blackwell & Baber
View video here: https://www.ispot.tv/ad/AN6b/lanham-blackwell-and-baber-hernia-physiomesh-helpline -
Ethicon Physiomesh Lawsuit Info; Ethicon Initiates Voluntarily Withdrawal Of Physiomesh Hernia Product
Sep 20, 2016 | Wright & Schulte
The FDA Received Reports That Use Of Surgical Mesh For Hernia Repair Can Cause Complications Such As Intestinal Blockage, Bleeding, Hernia Recurrence, And Infection. -
Ethicon Physiomesh Lawsuit Evaluations Offered by Bernstein Liebhard LLP to Individuals Who Experienced Recurrence, Revision Following Laparoscopic Ventral Hernia Repair
Sep 26, 2016 | Press Release
By Bernstein Liebhard
The nationwide law firm of Bernstein Liebhard LLP is now evaluating potential legal claims involving Ethicon, Inc.'s Physiomesh Flexible Composite Mesh, a surgical mesh that is used in laparoscopic (minimally-invasive) ventral hernia repair. Ethicon voluntarily withdrew this Physiomesh product from the market in May 2016, after unpublished data from two European registries indicated the recurrence and revision rates following laparoscopic ventral hernia pair were higher with the device than rates associated with the comparator set of mesh. -
Hernia Mesh Lawsuit Filed on Behalf of Ethicon Physiomesh Patient Scheduled for January 2018 Trial, Bernstein Liebhard LLP Reports
Sep 30, 2016 | Press Release
By Bernstein Liebhard
A hernia mesh lawsuit (http://www.rxinjuryhelp.com/ethicon-physiomesh/lawsuit/) filed on behalf of a patient who received Ethicon, Inc.'s Physiomesh Flexible Composite Mesh to repair an abdominal wall hernia is scheduled to go to trial in January 2018. A docket entry posted by the U.S. District Court, Southern District of Illinois, indicates that the Physiomesh lawsuit has been assigned to an 18-month track, with the trial to commence on January 22, 2018. (Case No. 3:16-cv-00368-JPG-PMF) -
Ethicon Hernia Physiomesh Recall Over High Failure Rates
Oct 18, 2016 | Legal Examiner
By Shezad Malik
Johnson & Johnson’s Ethicon unit has recalled its blockbuster hernia repair mesh medical device from the market worldwide, after it was found to cause severe side effects and surgical revisions. According to Johnson & Johnson the exact mechanism for the failures are unknown, and the company conveniently blamed patient factors and implanting doctors for the complications. -
Attorney: Ethicon Physiomesh Flexible Composite Mesh Recalled Due to High Revision Rates
Oct 24, 2016 | Lawyers and Settlements
By Heidi Turner
Dallas, TX Attorneys are investigating possible lawsuits against Johnson & Johnson subsidiary Ethicon concerning theEthicon Physiomesh Flexible Composite Mesh. The Physiomesh, used in laparoscopic hernia surgeries, has reportedly been linked to higher than normal revision rates. -
Ethicon Physiomesh Lawsuit Springs from Medical Device Withdrawl
Nov 2, 2016 | Lawyers and Settlements
Orlando, FL It wasn’t that long ago that problems associated with transvaginal mesh commanded headlines and fueled lawsuits. Now the mesh is back, but this time stemming from a different indication. The complaints, however, are similar: allegations of early failure causing pain and other health implications for the patient, prompting many to file a Surgical Mesh lawsuit. -
Ethicon Physiomesh
Nov 10, 2016 | Gary S. Logdson Associates
View video here: https://www.youtube.com/watch?v=IWDb-F4bpg0 -
Lawsuit Alleges Ethicon Physiomesh Led to Significant Injury
Dec 1, 2016 | Injury Lawyer News
By Whitney Taylor
A plaintiff filing a lawsuit against Ethicon claims the company’s Physiomesh flexible composite hernia mesh led to serious injuries after he was treated for hernia repair. -
Ethicon Recall of Physiomesh
Dec 12, 2016 | Legal Examiner
By Craig Kelley
In June of 2016 manufacturer, Ethicon, subsidiary of giant Johnson & Johnson, began to voluntarily recall the surgical mesh for hernias called Physiomesh. The product is a flexible composite mesh and it was found that revisions were needed in a large number of hernia repairs using Physiomesh. This recall was helpful in keeping the product from being used with patients in surgeries after the recall, but was of no good for those already having surgery with Physiomesh and suffering consequences. In fact, it has been estimated that as of November, 2016 300,000 Physiomesh implants might have been placed after its approval by the U.S. Food and Drug Administration in 2010! -
Johnson & Johnson’s Ethicon Composite Physiomesh Recalled
Dec 13, 2016 | Seeger Weis LLP
Ethicon, a subsidiary of the medical products giant Johnson & Johnson, is facing what may be only the first of multiple lawsuits to be filed for injuries caused by its Ethicon Physiomesh Flexible Composite Surgical mesh. -
Olinde & Mercer LLC Television Ad
Dec 14, 2016 | Olinde & Mercer LLC
View Clip Here: https://www.ispot.tv/ad/Aace/olinde-firm-ethicon-physiomesh# -
Hernia Mesh Complications Class Action Lawsuit Investigation
Dec 19, 2016 | Top Class Actions
The Physiomesh Flexible Composite Mesh device was approved to be marketed by the U.S. Food and Drug Administration (FDA) in March 2010 through the federal agency’s 510k fast-track approval program. This program allows medical device makers to pursue approval of a product by showing that it’s “substantially equivalent” to a similar product, without the standard requirements such as testing and research. -
Hernia Mesh Study Finds Higher Rate of Complications
Jan 3, 2017 | Top Class Actions
By Paul Tassin
According to a recent study, patients undergoing hernia surgery may face a risk of complications that may offset the benefits of hernia mesh. -
Davis & Crump Television Ad
Jan 3, 2017 | Davis & Crump Television Ad
View Clip Here: https://www.ispot.tv/ad/AelP/davis-and-crump-pc-hernia-mesh-complications
International Health Advisories
Media Coverage
Mesh Medical Device News
Plaintiff Attorney Activity
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(Netherlands) Field Safety Notice: Ethicon, ETHICON PHYSIOMESH™ Flexible Composite Mesh
May 30, 2016 | ArtsenApotheker
By Carrie Brodie-Meijer
Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB).
http://www.igz.nl/onderwerpen/medische-technologie/waarschuwingen/ethicon-ethicon-physiomesh-flexible-composite.aspx
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(Italy) Johnson & Johnson International - PHYSIOMESH
May 31, 2017 | Italian Ministry of Health
Manufacturer : JOHNSON & JOHNSON INTERNATIONAL
Device : PHYSIOMESH
PHYSIOMESH PHYXXXXX
Type : MD
Action : RECALL
Reference Number : 302237
Date of receipt : 1 June 2016
Number Directory (BD / RMD) of the device : 360828http://www.salute.gov.it/imgs/C_17_AvvisiSicurezza_6627_azione_itemAzione0_files_itemFiles0_fileAzione.pdf
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(France) Lattice - Ethicon Physiomesh ™ Flexible Composite Mesh - Ethicon - Batch Recall
Jun 16, 2016 | Agence Nationale de Sécurité du Médicament et des Produits de Santé
The ANSM was informed of the implementation of a removal product by ETHICON.
Affected users received the attached letter (06.06.2016) (360 kb) .This safety action is recorded to ANSM as No. R1602738.
http://ansm.sante.fr/content/download/89185/1121829/version/1/file/rlp-160606-ethicon.pdf
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(Australia) Hazard alert - higher rate of recurrence/reoperation
Jun 9, 2016 | Australian Department of Health
Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, is issuing a hazard alert for Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Johnson & Johnson Medical is also recalling all unused stock of these devices (all product codes and all lots).
Ethicon Physiomesh Flexible Composite Mesh is an implanted medical device that can be used in laparoscopic operations to repair ventral hernias and other fascial issues requiring a reinforcing or bridging material.
Analysis of unpublished data from two large independent overseas hernia registries (Germany and Denmark) has shown that laparoscopic ventral hernia repair using Ethicon Physiomesh Flexible Composite Mesh has a higher rate of recurrence/reoperation compared to the average rates of other similar products among patients in these registries.
The factors causing this increased rate cannot be fully determined at this time, but are believed to be multifactorial.
Based on this, a decision has been made to withdraw the device from the global market and provide what information is available to health professionals to assist in the management of affected patients.
Please note that this issue only affects Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). It does not affect Ethicon Physiomesh Open Flexible Composite Mesh or other hernia or urogynaecological mesh products.
Information for consumers
If you have had laparoscopic surgery to treat a ventral hernia using a mesh and you experience any signs or symptoms of recurrence of the hernia, talk to your health professional. They may refer you to your surgeon or to the hospital where the surgery was undertaken.
If you have any other questions or concerns about this issue, talk to your health professional.
Information for all health professionals
If you are treating a patient who has had laparoscopic surgery to treat a ventral hernia using a mesh, be aware of this issue.
If the patient is experiencing any signs or symptoms of recurrence of the hernia, or if they have any questions or concerns about this issue, refer them to their surgeon or the hospital where the surgery was undertaken.
Information for hospitals and surgeons
Hospitals should inspect their stock and quarantine any unused Ethicon Physiomesh Flexible Composite Mesh (for laparoscopic use). Contact Johnson & Johnson Medical on 1800 252 191 (option 1) to arrange the return of any recalled devices.
Management of the patient remains at the discretion of the treating health professional and should be based on the individual circumstances of the patient.
If you have any questions or concerns about this issue, contact Johnson & Johnson Medical on 02 9815 3661.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
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J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Jun 20, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh.
In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.
West Somerville, N.J.-based Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but hasn’t been able to pin down a cause.
“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to the letter. “Ethicon will not return theEthicon Physiomesh composite mesh product to the market worldwide.”
Patients already implanted with the product should be followed as usual, the company said. The recall does not involve any other Ethicon meshes, including the Physiomesh Open flexible composite mesh, it said.
“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company wrote.
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Hernia Mesh Benefits Offset by Long-Term Risks
Oct 28, 2016 | Daily Hornet
Hernia mesh prevented hernias from re-opening and needing another surgery in “relatively few patients,” but caused much higher rates of long-term complications, according to a new study..
In the United States, over 190,000 people had surgery to repair an incisional hernia in 2012. In at least half of those patients, hernia mesh was stitched into their abdomen to reinforce the abdominal wall.
Some types of hernia mesh have higher risks than others. In May 2016, Ethicon pulled Physiomesh off the market after two large studies in Germany and Denmark found higher rates of hernia recurrence and re-operation.
Because the long-term risks of hernia mesh are unknown, researchers decided to analyze outcomes for 3,242 patients in Denmark who had elective surgery to repair an incisional hernia between 2007 and 2010.
The good news is that hernia mesh appeared to help prevent hernias from recurring and needing another operation. Recurrence occurred in 17% of non-mesh repairs vs. 10-12% of patients who received hernia mesh implants.
Unfortunately, those benefits were offset by increasing rates of devastating mesh-related complications like bowel obstruction, bowel perforation, bleeding, and late abscess — especially in patients with larger-sized mesh.
After 5 years of follow-up, complications were at least 4X more likely in patients who received hernia mesh compared to patients who did not.
Only 0.8% of patients who did not receive hernia mesh developed a long-term complication. In comparison, mesh-related complications occurred after 3.7% of laparoscopic repairs and 5.6% of open repairs.
According to the authors of the study:
"Mesh implantation prevented the need for subsequent re-operation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”
The authors cautioned that the study results may have been skewed by selection bias. Large hernias were more likely to be repaired with mesh, and small hernias with little chance of long-term side effects were more likely to be repaired without mesh.
Source: Dunja Kokotovic, Thue Bisgaard, Frederik Helgstrand. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA, 2016.
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Johnson & Johnson's Ethicon sued over physiomesh product
Nov 11, 2016 | Florida Record
By Chandra Lye
A new lawsuit claims more patients have been having problems with medical mesh products.
A patient has filed a lawsuit against Ethicon, a branch of Johnson & Johnson, regarding the company's physiomesh product.
The plaintiff, Joanne Quinn, was surgically treated for hernia in 2014 and the mesh product was implanted into her abdomen. Her condition became worse after the surgery with abdominal pain, diminished bowel motility and bowel obstruction.
Nearly a year later she underwent another surgery to remove the mesh product. The operation took over two hours and the doctor was unable to remove all of the product. Doctors stated that the mesh had become stuck to the abdomen walls and bowels.
In her suit in the U.S. District Court for the Middle District of Florida, Orlando Division, Quinn claims she has suffered mentally and physically and has had economic loss due to the complications.
She alleges the defendants were aware of the dangers and risks of the product they were marketing.
“Defendants failed to exercise reasonable care in determining the risks and potential adverse consequences of implanting the product into patients,” court documents stated.
Product liability expert and attorney Michael Cerasa said he expected to see this case consolidated with other similar ones.
"What that will involve is a federal judge somewhere in the United States will be appointed to oversee all of the cases nationwide and that is where you will start to see test trials and things of that nature and really see the movement in terms of proving or disproving the allegations,” Cerasa told the Florida Record.
"I expect that this latest Ethicon case will get huge,” he added.
Physiomesh has since been recalled by the federal Food and Drug Administration. The manufacturer issued a voluntary recall in May. The company has given full refunds to healthcare facilities and medical professionals for products returned by Sept. 16. The company said in a statement that the made the decision “following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries."
“Ethicon believes the higher rates to be a multifactorial issue,” the recall notice stated. “Ethicon have [sic] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall Ethicon Physiomesh Composite Mesh from the global market.”
Cerasa said this recall can be evidence for the case but it does not conclude the plaintiff is correct.
“An FDA finding has no definitive bearing on a lawsuit. The suit is still going to be depending primarily on the science and what both sides prove as to whether or not the product is defective. FDA notices or recalls can be used as evidence in the case but they are not determinate as to whether a product would be defective or not in a legal sense,” he explained.
Ethicon declined to comment on the case.
The company has been working in the industry for over 80 years. It began making mesh for hernia patients in 1998. According to its website, it has sponsored the International Hernia Mesh Registry since 2007. It boasts 40 international sites and about 4,300 patients.
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Ethicon Recalls Physiomesh Hernia Mesh in Europe, Australia
Dec 13, 2016 | Daily Hornet
By Elizabeth Bradley
Ethicon Inc., a subsidiary of Johnson & Johnson, stopped selling all Physiomesh™ Flexible Composite Hernia Mesh worldwide after a large study discovered a possible safety risk for patients.
Ethicon recalled Physiomesh in Europe and Australia, but the same action was called a “market withdrawal” in the U.S., which is why the FDA did not make any announcements to warn patients.
According to an Urgent Field Safety Notice to surgeons on May 25, Ethicon recalled Physiomesh after analyzing unpublished data from two large independent hernia registries in Germany and Denmark.
The studies showed Physiomesh had higher rates of hernias returning and needing another surgery (called “recurrence and re-operation”) compared to similar types of hernia mesh for laparoscopic ventral hernia repairs.
Ethicon blamed the complications on multiple factors, including possible “product characteristics, operative and patient factors,” but decided to remove it from the market rather than fix the issues.
Ethicon said the “voluntary recall has been communicated to the U.S. Food and Drug Administration (FDA).” The FDA classified the action as a market withdrawal rather than a recall.
On June 9, the Australian Therapeutic Goods Administration (TGA) announced a recall for Physiomesh and asked surgeons to return all unused stock of the devices.
Before the recall, Physiomesh lawsuits accused Ethicon of selling a defective hernia mesh implant. The first case is set for trial on January 22, 2018 in Illinois — Case No. 3:16-cv-0036.
Hernia patients who were implanted with Physiomesh should continue to follow-up with their doctors as usual. The symptoms of a failed surgery may include the following injuries:
Dense adhesions
No ingrowth
Bowel obstruction
Pain
Hernia recurrence
Seroma
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Lawsuits Scheduled for Ethicon’s Physiomesh Hernia Mesh
Oct 25, 2016 | Mesh Medical Device News
By Jane Akre
The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended.
Medical professionals had until September 16, 2016 to return unused Physiomesh, hernia mesh, for a full refund after the product was recalled by its manufacturer, Ethicon, a division of Johnson & Johnson. Ethicon issued a recall of Physiomesh last May after studies showed it failed when used in hernia surgeries when compared to other similar hernia meshes.
The mesh was used in laparoscopoic and ventral and inguinal hernia repair surgeries.
The voluntary recall was conducted by Ethicon, the U.S. Food and Drug Administration and its European counterparts.
Here is the Urgent: Field Safety Notice. Here are the Product Code numbers.
THE PROBLEM
Two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, suggested its failure rate for laparoscopic ventral hernia surgeries were higher than the other meshes used on patients in these registries.
“The recurrence/reoperation rates (retrospectively after laparoscopic ventral hernia repair using Ethicon Physiomesh compositve Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Physiomesh is made of polypropylene but the studies found it broke down in its structure which can allow the hernia to recur or cause bacterial infections and swelling at the surgery site, requiring another surgery. Ethicon suggests surgeons replace it with Proceed surgical mesh, Prolene, Prolene Soft, or Ultrapro mesh, all made by Ethicon.
Physiomesh was approved under the 510(k) clearance of the FDA in April 2010, which does not require clinical trials for safety and efficacy.
Physiomesh is made of a flexibile composite mesh “composed of nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh.”
Ethicon developed Physiomesh Open the latest version of the type of mesh and it was introduced in 2014. Both messes were marketed following the fast tracked 510(k) approval process by the FDA. Physiomesh Open is not involved in this recall.
On its website Ethicon claims “ Physiomesh Open is built on the proven technology of the #1 selling tissue-separating mesh Open Flexible Composite Mesh, and optimized for open ventral hernia repair.”
LAWSUITS FILED
A number of lawsuits have already been filed. Matthew Huff was implanted with Physiomesh in 2013 to repair a ventral hernia. In July 2015, he developed severe abdominal pain, ever, chills, nausea and redness. He was treated for an infection and two abscesses and an intestinal fistula. His case is set for January 22, 2018 in the Southern District of Illinois. Case No. 3:16-cv-00368.
Another product liability lawsuit was filed in the U.S. District Court Middle District of Florida September 22nd claims the mesh is defective and caused her persistent abdominal pain, diminished bowel motility and bowel obstruction.
Here is an adverse event report submitted to the FDA that says the mesh pulled away from he abdominal wall resulting in a second surgery.
In June 2012, Ethicon removed four transvaginal meshes from the market- Prolift, ProliftM+, TVT Secur and Prosima Pelvic Floor Repair System. The company said the removal was for business reasons.
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Ten Deaths Associated With J&J Physiomesh Hernia Mesh
Dec 15, 2016 | Mesh Medical Device News
By Jane Akre
At least 10 deaths and seven injuries, associated with PHYSIOMESH™ (JNJ) hernia mesh, have been reported to the U.S. Food and Drug Administration (FDA). Device Events worked with Mesh News Desk in preparation of this story.
Civil lawsuits that become mass torts involving many plaintiffs, with similar injuries, tend to run with the trends.
For many years, transvaginal mesh was the top tort. Now, with many of those cases settling, trial lawyers, and their legal referral services, are turning their attention to hernia mesh.
Also made of polypropylene, more than a million hernia repairs are done every year. Recipients are reporting the same complications as transvaginal mesh patients – chronic pain and infection, mesh shrinkage, mesh migration, and organ perforation etc.
Lawyers are focusing specifically on coated hernia meshes, preparing cases for future litigation, specifically Atrium C-Qur and PHYSIOMESH™ made by Ethicon, a division of Johnson & Johnson (JNJ). Ethicon voluntarily recalled PHYSIOMESH™ from the market in May.
The Urgent: Field Safety Notice, notes two unpublished studies that found PHYSIOMESH™ had higher failure rates for laparoscopic ventral hernia surgeries than other meshes used in a German and Danish Medical Registry.
The Voluntary product recall states unpublished data found, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
It’s estimated 300,000 patients have been implanted with PHYSIOMESH™ since it was cleared by the FDA for sale via the 510 (k) process in 2010. (here)
The Field Safety Notice says nothing about deaths.
TEN DEATHS ASSOCIATED WITH PHYSIOMESH™
Device Events, is an investigative tool that uses proprietary algorithms designed by developer Madris Tomes. Formerly with the FDA, Tomes investigates under-reported or mis-reported entries to the complication databases of the FDA to look for patterns of injury or death.
In all, Ms. Tomes shared 7 injury and 10 death reports associated with PHYSIOMESH™ hernia mesh with Mesh Medical Device News Desk.
“While the FDA requires manufacturers and hospitals to report deaths due to devices, if there is any leeway or room for interpretation, often the reports come in as injuries or malfunctions. Tens of thousands of deaths have been extremely difficult to find due to this regulatory ambiguity and dirty data. This can be the critical data point needed for mesh and countless other medical device cases.”~Madris Tomes, Device Events
Further exploration of deaths and injury via additional search terms (such as manufacturer and a host of search terms used to unearth findings), are available via a subscription to Device Events.
MANUFACTURER MUST REPORT ADVERSE EVENTS TO FDA
Hospitals, the manufacturers and importers are required to filed adverse event reports with the FDA. Lawyers, doctors, and patients may file an adverse event report to the FDA. See how to here. An Adverse Event report means the device “may” have caused or contributed to death or serious injury, according to Isaac Chang, Ph.D, Director of the Division of Postmarket Surveillance with the FDA.
Certain malfunctions, such as a product failure, improper design, labeling and manufacturing problems, failure to meet performance specifications and use error must also be reported. Those incidents may have been a factor in a death or serious injury.
SEPSIS AND INFECTION
The ten deaths reported to the MAUDE database, almost always involved infection.
Sepsis is the most common word for a bacterial, fungal or viral infection of the bloodstream according to Mayo Clinic here. It should be treated in the early stages before progressing to severe septic shock which can be fatal, especially in an older person or someone with a weakened immune system.
Its origin can be introduction of an invasive device or injury to the bowel which releases bacteria into the system.
Organs can fail from severe sepsis, gangrene or tissue death.
Bowel violation, says a report on Patient 8. The patient died from sepsis after straps of the mesh were turned into the fascia violating the bowel.
Patient 14 (above) is listed as an injury report, even though it later said the “patient had a generalized infection and died” after a PHYSIOMESH™ implant and suffering two injuries to the small intestine.
In some cases, initial injury reports are not updated when the patient expires.
Patient 23 is an injury report with sepsis and the “mesh breaking up” and a “hole in the mesh” necrosis, and “resection of small bowel,” (see above) yet the reporter, JNJ, says the “mesh met the finished goods criteria,” in other words, it did not test as defective.
PHYSIOMESH™ problems have included a failure of the mesh to incorporate with the body, largely blamed on the laminated coating on the polypropylene (PP).
The PHYSIOMESH™ is constructed of knitted filaments of extruded PP with an additional dyed polydioxanone film marker, added for orientation purposes. The coatings were added to each side to avoid contact with tissue and organs and bowel. But with no PP exposed, the hernia mesh may not incorporate into the body, leaving it potentially floating and moving around in the patient.
Also, since less PP was used to make PHYSIOMESH™ “lightweight,” it is considered to be weaker than standard hernia mesh made of polypropylene.
The PHYSIOMESH™ may tear apart as a result, according to trial attorneys pursuing these cases.
NATURAL DEATH
Patient 20 was considered obese with chronic steroid use.
Those are the factors contributing to his surgical site infection and wheezing, according to the entry. The mesh separated and did not adhere to the intestinal loops. Fasciitis and infection were observed.
A new mesh was implanted. He died four weeks after the PHYSIOMESH™ was implanted.
His death was attributed to bronchoaspiration and respiratory failure.
An autopsy was not ordered due to the “natural death.”
When Patient 24 presented with a 104.5 fever following his PHYSIOMESH™ implant, as well as sepsis, he had the mesh removed. In 12 hours, the report says, “the patient got better.”
Two of the reports to the FDA appear to go out of their way to avoid connecting the mesh to the patient’s death.
In the Patient 21 death report, which notes complications and sepsis after a mesh implant, the manufacturer reports there is “no reason to suspect the mesh malfunctioned and caused the patient death.”
Patient 16’s death, J&J reports, is “not related to mesh but to co-morbidity.” The patient had two surgeries, was bleeding from the trocar site and had necrosis of the colon.
Another death report, Patient 17, reports he died six days post-op. The patient was enrolled in a study of patients with peritonitis to prevent incisional hernias. The patient suffered three small bowel resections during the procedure. The patient passed out in the hospital and hit his head. He died after 45 minutes of resuscitation.
ETHICON RESPONDS
Ethicon’s newer version of Physiomesh, ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, approved October 23, 2014, remains on the market and is not related to the product withdrawl of PHYSIOMESH.
Here is its 510 (K) report.
Removing PHYSIOMESH™ from the market does not qualify as an FDA recall.
A call to JNJ to respond to these reports had gone unanswered by deadline. Any additional comments will be added when and if they are received. ###
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Ethicon Physiomesh Recall Issued Amid High Revision Rates
Jun 21, 2016 | AboutLawsuits.com
By Irvin Jackson
Johnson & Johnson’s Ethicon unit has issued a recall for a line of hernia repair mesh that has been linked to a high rate of problems and revisions, after the manufacturer failed to identify what is causing the problems.
An Ethicon Physiomesh recall was announced last month in an Urgent Field Safety Notice sent to operating room managers, materials management personnel and surgical chiefs at hospitals worldwide.
The notice lists product codes for Ethicon Physiomesh Flexible Composite Mesh impacted by the recall, which was issued after an analysis of unpublished data found that the products have higher than average recurrence and reoperation rates following laparoscopic ventral hernia repair. The data came from the Herniamed German Registry and the Danish Hernia Database (DHDB).
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the field notice warns. “Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”
Ethicon indicates that it has notified both the FDA and the European Competent Authorities to inform them of the hernia mesh recall.
The recall affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R. The mesh products came in square, oval and rectangle shapes. The recall does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.
Ethicon is calling on its customers to examine their inventories to determine if they have affected mesh products, and to complete a Business Reply Form attached to the field notice even if they do not have the product being recalled. The company indicates that customers are required to return the recalled, unexpired Ethicon Physiomesh devices immediately. It is only reimbursing those who return unexpired mesh products by September 16, 2016.
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Ethicon Hernia Mesh Lawsuits Now Being Investigated By Southern Med Law Following Physiomesh Recall
Jul 8, 2016 | Southern Med Law
Southern Med Law, a law firm that represents the victims of defective medical devices, is now evaluating Ethicon hernia mesh lawsuits involving Ethicon, Inc.’s worldwide recall of Physiomesh Flexible Composite Mesh. Ethicon, a division of Johnson & Johnson, announced the Physiomesh recall via an Urgent Field Safety Notice issued to surgeons in May 2006.
According to the company, unpublished data from two large independent hernia registries in Germany and Denmark suggested that this product was associated with higher rates of hernia recurrence and re-operation compared to similar products that are used in laparoscopic ventral hernia repair.
“Physiomesh patients who experienced hernia recurrence following laparoscopic ventral hernia repair with this recalled device may be entitled to compensation from Ethicon, Inc. We are offering free legal reviews to anyone who may have incurred medical bills, lost wages, pain and suffering, and other damages that could be related to the Ethicon hernia mesh recall,” said Dr. François Blaudeau, the founder of Southern Med Law. For more information on hernia mesh lawsuits and to speak with an attorney call 1-205-547-5525 or visit www.southernmedlaw.com for further information or to fill out a contact form.
Physiomesh Flexible Composite Mesh is made from flexible, non-absorbable polypropylene filaments that are woven into a fabric and laminated. It is used to repair ventral hernias, which can occur at the site of a previous surgical incision. Ethicon brought Physiomesh to market in 2010, following approval via the U.S. Food & Drug Administration’s 510(k) clearance protocols. This process does not require a device manufacturer to conduct human clinical trials of a new product when it is shown to be “substantially equivalent” to another device that was previously approved by the agency.
The Ethicon hernia mesh recall involves all unexpired product codes of Physiomesh Flexible Composite Mesh and all unexpired Procedure Packs containing the product. The action does not involve any other Ethicon meshes, including another product called Physiomesh Open flexible composite mesh. Ethicon has advised physicians to follow any patients treated with the recalled hernia mesh in the usual manner.
According to Ethicon, the high revision rates associated with the recalled Physiomesh appear to be due to multifactorial issue,” possibly including “product characteristics, operative and patient factors.” At this time, the company said it is unable to issue further instructions to surgeons that might lead to a reduction in the recurrence rate. The company will not be returning Physiomesh Flexible Composite Mesh to the worldwide market.
As both an attorney and practicing obstetrician/ gynecologist with a specialization in advanced gynecological surgery, Dr. Blaudeau possesses a unique understanding of the factors involved in all manner of medical device lawsuits, including those that could potentially stem from the Ethicon Physiomesh recall. If you or a loved one experienced complications that may be related to this hernia mesh recall, please contact Southern Med Law today to learn more about your legal rights. You can arrange for at 205-547-5525.
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Physiomesh Lawsuit Information Webpage Looks To Inform Of Possible Hernia Mesh Failure
Aug 22, 2016 | Southern Med Law
Southern Med Law has launched a Physiomesh Lawsuit information page to provide Information to the public on Ethicon Inc.’s voluntary withdrawal of Ethicon Physiomesh Flexible Composite Mesh. The Johnson & Johnson subsidiary is removing its hernia mesh product from the worldwide market due to higher-than-average revision rates after use. Ethicon said it would no longer sell its Physiomesh Flexible Composite Mesh. Ethicon is also involved in litigation over its transvaginal mesh products which women allege causes organ perforation, chronic pain, mesh erosion, infection, scar tissue, and other injuries. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, U.S. District Court, Southern District of West Virginia)
“We want to make the public aware about the potential for hernia recurrence or having to undergo revision surgeries due to Ethicon’s hernia mesh product,” says Dr. François Blaudeau, founder of Southern Med Law. “Patients who have suffered serious injuries may be entitled to compensation from Ethicon.” For more information on hernia mesh lawsuits and to speak with an attorney, call 1-205-547-5525 or visit www.southernmedlaw.com for further information or to fill out a contact form.
Southern Med Law is now offering free, no-obligation Ethicon Physiomesh Lawsuit case reviews to individuals who have been injured by the hernia mesh Physiomesh failure as well as transvaginal mesh products that treat stress urinary incontinence and pelvic organ prolapse. To arrange for an Ethicon Physiomesh lawsuit review, please contact Dr. François Blaudeau and the legal staff at Southern Med Law filling out our online form, or by calling the office directly at 205-547-5525.
Ethicon Physiomesh said it was voluntarily withdrawing its product after an analysis of unpublished data from a Danish hernia registry and a German hernia registry showed higher than average rates of hernia recurrence and revision surgeries after a minimally invasive ventral hernia repair compared to other meshes. Ethicon said it was not sure why the rates were higher but believes “possible product characteristics, operative and patient factors” may have played a role. Ethicon’s action does not involve any other Ethicon meshes, including the Ethicon Physiomesh Open flexible composite mesh.
[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon Inc., May 25, 2016]Ethicon Physiomesh Flexible Composite Mesh received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2010. The large pore, flexible composite mesh is made of non-absorbable polypropylene and used in minimally invasive ventral hernia repair and other fascial deficiencies. According to the FDA, the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration and mesh shrinkage.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm, FDA, April 7, 2016]In addition to its hernia mesh, Ethicon is also handling issues over its pelvic mesh that treats pelvic organ prolapse and stress urinary incontinence in women. Court documents indicate that more than 32,000 mesh complaints are pending in the U.S. District Court, District of Southern West Virginia alleging that Ethicon failed to adequately warn about the risks associated with its bladder mesh implants. Bladder mesh lawsuits allege that women suffer such injuries and complications as urinary problems, nerve damage, chronic pelvic pain, and pain during sexual intercourse. (In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, U.S. District Court, Southern District of West Virginia)
About Southern Med Law And Filing A Physiomesh Lawsuit
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or someone you care about were harmed by Physiomesh Flexible Composite Mesh, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation hernia mesh lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
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Ethicon Physiomesh Lawsuit Set for Trial in January 2018
Sep 16, 2016 | AboutLawsuits.com
By Irvin Jackson
One of the first lawsuits filed against Johnson & Johnson’s Ethicon subsidiary over problems with Physiomesh used for hernia repair, is slated to go before a jury in January 2018, as a growing number of individuals continue to pursue cases in the wake of a recall issued earlier this year, due to high failure rates.
An Ethicon Physiomesh recall was issued in May 2016, amid a large number of failures and revision surgeries, since the manufacturer was unable to identify the cause of the problems associated with the controversial hernia mesh.
Matthew Huff brought a lawsuit over Ethicon Physiomesh problems weeks before the recall, filing a complaint (PDF) in the U.S. District Court for the Southern District of Illinois on April 1, alleging that the hernia repair mesh was defective, unreasonably dangerous and not suitable for it’s intended use.
Huff indicates that an Ethicon Physiomesh Flexible Composite Mesh product was implanted in 2013, for treatment of an abdominal wall hernia. In July 2015, Huff began to experience severe pain in the abdomen, as well as fever, nausea, chills and redness on the skin of his abdomen. During a subsequent hospitalization, it was discovered that the hernia mesh was infected, resulting in two abdominal abscesses, intestinal fistula and the need for surgery to debride the abscesses.
As a result of the complications with Ethicon Phsyiomesh, Huff claims that he was left with severe and serious health problems, including two open abdominal wounds that need to be cleaned and packed daily, as well as other injuries.
According to a docket entry posted by the court, the case has been assigned to an 18-month track, which calls for the case to go to trial before Judge J. Phil Gilbert on January 22, 2018.
By the time that trial date arrives, it is expected that hundreds, if not thousands, of similar Ethicon Physiomesh lawsuits may be filed in U.S. District Courts nationwide, each involving similar allegations. Therefore, the trial in the Huff case may be delayed if centralized proceedings are established in the federal court system to consolidate the cases before one judge for coordinated discovery, motions and other pretrial litigation.
Huff presents claims for strict liability, negligence and breach of warranties, seeking both compensatory and punitive damages.
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Lanham Blackwell & Baber Television Ad
Sep 19, 2016 | Lanham Blackwell & Baber
View video here: https://www.ispot.tv/ad/AN6b/lanham-blackwell-and-baber-hernia-physiomesh-helpline
Rough Transcript: Have you or a loved one had an Ethicon Physiomesh implanted specifically for laparoscopic hernia repair between October 2010 and June 2016 that later required revision or repair surgery? You may be entitled to compensation. In May of 2016 Ethicon, a division of Johnson & Johnson, has withdrawn its Physiomesh after two studies found higher rates of hernias reopening and additional surgery compared to similar products used for laparoscopic repair, a minimally invasive surgery. Complications include pain, adhesions, mesh migrations, scarring and other adverse reactions. If you or a loved one had an Ethicon Physiomesh implanted specifically for laparoscopic hernia repair between October 2010 and June 2016 that later required revision or repair surgery, you may be entitled to compensation. How do you protect your rights and fight for the compensation you deserve? You choose the right legal team that has the right experience, support staff and resources to get you the most compensation for your injuries, call for a free case review
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Sep 20, 2016 | Wright & Schulte
The FDA Received Reports That Use Of Surgical Mesh For Hernia Repair Can Cause Complications Such As Intestinal Blockage, Bleeding, Hernia Recurrence, And Infection.
Ethicon Physiomesh lawsuit information: Ethicon has voluntarily removed its Physiomesh Flexible Composite Mesh from the global market after an analysis found minimally invasive ventral hernia repairs that use the product have higher rates of hernia recurrence and additional surgery compared to similar hernia mesh devices. Ethicon, a wholly-own subsidiary of Johnson & Johnson, advised health care professionals of its intentions through an Urgent Field Safety Notice in May. Ethicon’s action does not include a market withdrawal of its Physiometh Open Flexible Composite Mesh Device or other hernia mesh products made or sold by the company.
“Studies show that patients are placed at a higher risk for complications when the hernia mesh is used,” says Wright & Schulte LLC, a nationwide law firm which represents individuals injured by medical devices.
Investigating Ethicon Physiomesh Lawsuits And Legal Claims Surrounding Hernia Mesh Injuries
The attorneys at Wright & Schulte LLC are investigating Ethicon Physiomesh lawsuits and legal claims surrounding personal injuries from the Ethicon Physiomesh Flexible Composite Mesh. If you believe you or a loved one have experienced a recurrence of the hernia or had additional surgeries due to the Ethicon Physiomesh Flexible Composite Mesh or other surgical mesh medical devices, contact Wright & Schulte LLC for a free Ethicon Physiomesh lawsuit or Ethicon hernia mesh lawsuit consultation by calling 1-800-399-0795 or you can visit yourlegalhelp.com for more information.
Physiomesh Flexible Composite Mesh Has Higher Rate Of Recurrence/Reoperation Compared To Rates Of Similar Products
According to Ethicon, an analysis of unpublished data from two large independent registries in Germany and Denmark has found that laparoscopic ventral hernia repair using its Physiomesh Flexible Composite Mesh has a higher rate of recurrence/reoperation compared to the average rates of other similar products among patients in these registries. In an Urgent Field Safety Notice to health care professionals, Ethicon said it believes the higher rates are due to multiple factors, including “possible product characteristics, operative and patient factors, but the “increased rate cannot be fully determined at this time.” As a result, Ethicon said that it has not been able “to issue further instructions to surgeons that might lead to a reduction in the recurrence rate.”
Ethicon Physiomesh Flexible Composite Mesh is a sterile, flexible composite mesh used to repair hernias and other fascial defects in the abdominal wall that cause hernias. Ethicon’s hernia mesh received 510(k) clearance by the U.S. Food and Drug Administration (FDA) in 2010. Under the federal agency’s 510(k) process, manufacturers are not required to conduct human clinical trials of a medical device before it is launched on the market if they can prove that their products are substantially equivalent to a medical device already on the market. Ethicon reported at the time that its Physiomesh was substantially equivalent to its Proceed surgical mesh which is used to repair existing hernias and prevent new hernias. According to the FDA, there has been an increase in hernia mesh surgical repairs since the 1980s. However, surgical mesh can cause complications including pain, infection, hernia recurrence, and fistulas (abnormal connection between organs, vessels or intestines).
Over 33,000 Other Mesh Lawsuits Due To Injuries
In addition to hernia repair mesh, Ethicon also offers tranvaginal mesh medical devices that are used to treat stress urinary incontinence and pelvic organ prolapse in women. Currently, court documents show that Ethicon is facing over 33,000 vaginal mesh lawsuit claims in the U.S. District Court, Southern District of West Virginia. The complaints allege that Ethicon’s bladder mesh products are defectively designed and can cause serious injuries including urinary problems, vaginal scarring, infection, organ perforation, and chronic nerve damage.
About Wright & Schulte LLC And Filing An Ethicon Physiomesh Lawsuit
Wright & Schulte LLC, is an experienced personal injury firm and is dedicated to it’s clients and the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure corporations take responsibility for their actions. If you are looking for a law firm that will guarantee the aggressive and personal representation you deserve, do not hesitate to contact Wright & Schulte LLC today. Free Ethicon Physiomesh lawsuit or Ethicon hernia mesh lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.
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Sep 26, 2016 | Press Release
By Bernstein Liebhard
The nationwide law firm of Bernstein Liebhard LLP is now evaluating potential legal claims involving Ethicon, Inc.'s Physiomesh Flexible Composite Mesh, a surgical mesh that is used in laparoscopic (minimally-invasive) ventral hernia repair. Ethicon voluntarily withdrew this Physiomesh product from the market in May 2016, after unpublished data from two European registries indicated the recurrence and revision rates following laparoscopic ventral hernia pair were higher with the device than rates associated with the comparator set of mesh.
"Patients who experience recurrence of their ventral hernia following laparoscopic surgery with this Physiomesh product may be entitled to compensation for injury-related damages. We urge anyone who may have suffered these types of complications to contact our Firm as soon as possible," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.
Physiomesh Market Withdrawal
Ethicon Physiomesh Flexible Composite Mesh was brought to market in 2010, after receiving regulatory clearance via the U.S. Food & Drug Administration's (FDA) 510K program. This process does not require a device manufacturer to conduct human clinical trials, as long as it can be demonstrated that the new product is substantially equivalent to another device that was previously approved by the FDA\
On May 25, 2016, Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh, due to the higher recurrence and revision rates seen in the unpublished European data. Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors. The company indicated that it had informed the FDA of the action, and said that it would not be returning the affected Physiomesh product to the worldwide market.
Individuals who experienced recurrence and revision following laparoscopic ventral hernia repair with Ethicon Physiomesh Flexible Composite Mesh may be entitled to compensation for medical bills, lost wages, pain and suffering and more. To learn more about filing an Ethicon Physiomesh lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list. -
Sep 30, 2016 | Press Release
By Bernstein Liebhard
A hernia mesh lawsuit (http://www.rxinjuryhelp.com/ethicon-physiomesh/lawsuit/) filed on behalf of a patient who received Ethicon, Inc.'s Physiomesh Flexible Composite Mesh to repair an abdominal wall hernia is scheduled to go to trial in January 2018. A docket entry posted by the U.S. District Court, Southern District of Illinois, indicates that the Physiomesh lawsuit has been assigned to an 18-month track, with the trial to commence on January 22, 2018. (Case No. 3:16-cv-00368-JPG-PMF)
According to a complaint dated April 1, 2016, the Plaintiff underwent hernia surgery with the Physiomesh device in 2013. He began experiencing severe abdominal pain, chills and redness on the skin of his abdomen in July 2015. After being hospitalized, it was found that his hernia mesh had become infected, resulting in two abdominal abscesses and an intestinal fistula. The plaintiff, who was forced to undergo surgery to debride the abscesses, claims that the Physiomesh device used in his hernia surgery was defective, unreasonably dangerous and not suitable for its intended use.
"This Physiomesh product was voluntarily withdrawn from the global market in May, due to high rates of hernia recurrence and revision in patients who had undergone laparoscopic ventral hernia repair. Our Firm has heard from a number of individuals who have experienced similar complications allegedly due to this hernia mesh, and we are monitoring the progress of this lawsuit very closely," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now evaluating hernia mesh lawsuits involving injuries and complications allegedly related to Ethicon's Physiomesh Flexible Composite Mesh.
Physiomesh Market Withdrawal
Ethicon Physiomesh Flexible Composite Mesh is an implantable tissue-separating mesh designed to be physiologically compatible with the abdominal wall. It is manufactured from flexible, non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated. Physiomesh Flexible Composite Mesh was cleared by the U.S. Food & Drug Administration (FDA) in 2010, via the agency's 510K program. This program does not require a device manufacturer to conduct human clinical trials, as long as it can be demonstrated that the new product is substantially equivalent to another device that was previously approved by the FDA.
Ethicon announced the worldwide market withdrawal of Physiomesh Flexible Composite Mesh on May 25, 2016. According to the company, unpublished data from two European registries indicated the recurrence and revision rates following laparoscopic ventral hernia pair were higher with the device than rates associated with the comparator set of mesh. Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors. According to the company's notification, Physiomesh Flexible Composite Mesh will not be returned to the market.
Bernstein Liebhard LLP is offering free, no-obligation legal reviews to patients who experienced serious complications following hernia repair with Physiomesh Flexible Composite Mesh. To learn more about filing a hernia mesh lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
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Ethicon Hernia Physiomesh Recall Over High Failure Rates
Oct 18, 2016 | Legal Examiner
By Shezad Malik
Johnson & Johnson’s Ethicon unit has recalled its blockbuster hernia repair mesh medical device from the market worldwide, after it was found to cause severe side effects and surgical revisions. According to Johnson & Johnson the exact mechanism for the failures are unknown, and the company conveniently blamed patient factors and implanting doctors for the complications.
The Ethicon Physiomesh recall was announced recently in an Urgent Field Safety Notice sent to doctors and hospitals worldwide.
The FDA has classified the action as a “Market Withdrawal”, and Johnson & Johnson is requiring doctors and hospitals to return unexpired products for a refund.
What is Ethicon Physiomesh?
Ethicon uses plastic or polypropylene to make the base layer of the Physiomesh. The Physiomesh is used for laparoscopic ventral (abdominal) and inguinal (groin) hernia repair.
Polypropylene is the same material that Ethicon used to make their transvaginal mesh and bladder slings. Ethicon is exposed to thousands of lawsuits over its polypropylene transvaginal mesh and bladder slings. Ethicon added an absorbable film coating to each side of the polypropylene to create the Physiomesh. The coating on each side of the Physiomesh is composed of slightly different compounds.
German and Danish Medical Registries found the problem
The Ethicon Physiomesh Flexible Composite Mesh stealth recall was issued after an analysis of data found that the products have higher than average recurrence and re-operation rates following laparoscopic ventral hernia repair. The data came from the Herniamed German Registry and the Danish Hernia Database.
Unfortunately here in the U.S. we do not have a nationwide registry of side effects or failures associated with our medical products. And when patients or doctors complain or raise an issue with a product, they tend to get swept under the rug and the big medical device makers deny any problems until it is too big to contain or it may come to light from whistle blower action.
According to the Urgent Field Notice, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.
Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”
Recalled Ethicon Physiomesh Lots
The action affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R.
The recall does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.
Ethicon Physiomesh Lawsuits
Patients and surgeons have been complaining about the complications and the need for re-do surgery when the abdominal or inguinal hernia recurred.
The Physiomesh device was a big hit for Johnson & Johnson. Before the Physiomesh recall, Ethicon developed the Physiomesh Open. Ethicon submitted a 510(k) application for the Physiomesh Open in June, 2014, and received clearance in October, 2014.
Ethicon gave the Physiomesh Open about half a year to gain market traction before they finally decided to “voluntarily withdraw” the regular Physiomesh from the market.
Several Physiomesh lawsuits have been filed against Ethicon and Johnson & Johnson, with the first one slated to go to trial in January 2018. Ethicon has been battling lawsuits for years against its transvaginal mesh products, which are also made from polypropylene.
According to the lawsuits, the Physiomesh products were defectively designed and manufactured, using plastic materials that react to human tissues, causes infections and can migrate to other parts of the body. The lawsuits also indicates that the plastic mesh can cut tissues and fails to actually perform as intended leading to recurrence of the hernias.
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Attorney: Ethicon Physiomesh Flexible Composite Mesh Recalled Due to High Revision Rates
Oct 24, 2016 | Lawyers and Settlements
By Heidi Turner
Dallas, TX Attorneys are investigating possible lawsuits against Johnson & Johnson subsidiary Ethicon concerning theEthicon Physiomesh Flexible Composite Mesh. The Physiomesh, used in laparoscopic hernia surgeries, has reportedly been linked to higher than normal revision rates.
In May 2016, the Ethicon Physiomesh Flexible Composite Mesh products were voluntarily recalled by the company after two unpublished studies suggested the medical implants had higher failure rates than other mesh products available on the market. Ethicon gave medical professionals up to September 16, 2016, to return unused products for a full refund. According to the recall issued by Ethicon, "The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries."
The Physiomesh composite mesh was designed for use in laparoscopic hernia surgeries, including ventral and inguinal hernia repair. It is made of polypropylene, which has also been used in transvaginal mesh. According to Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, lawsuits have already been filed by patients who allege they were harmed by Ethicon's Physiomesh composite mesh.
"There were two big studies done, one involving the German Medical Registry and one involving the Danish Medical Registry," Dr. Malik says. "Compared with other available meshes, the Ethicon Physiomesh was shown to fail earlier than the other options on the market. Patients are reportedly experiencing more side effects. Ethicon says it is unclear what is going on, but they're saying it could be because of the patient or the physician or a host of as yet unidentified causes."
At issue is the mesh breaking down too early, which can allow hernias to recur, or can cause bacterial infections, damage to the internal organs, and the need to redo the surgery. Patients who have the Physiomesh implanted are encouraged to follow up with their doctors to ensure there are no problems with their mesh.
Symptoms of mesh failure include recurrence of the hernia, bacterial infection—marked by fever and chills—pain or swelling at the operative site, fluid-filled abscesses in the abdomen and groin, and perforation of the organs or blood vessels. Patients who have had laparoscopic hernia surgery and are not sure what mesh device was used can ask their surgeons for the operative report, request their medical records from the hospital or clinic, or look through billing records to see if the mesh is listed as a line item.
Patients who have suffered a hernia, had the Ethicon Physiomesh implanted, and suffered adverse effects as a result of that Physiomesh may be eligible to file a lawsuit against the medical device company. A few lawsuits have already been filed with the first trial reportedly expected in 2018.
The recall does not involve the Physiomesh Open product, which was approved more recently than the Flexible Composite Mesh.
"In 2014, Johnson & Johnson came out with the Physiomesh Open, went through the controversial 510(k) process, which bypasses rigorous safety data testing, and had it rubber stamped by the FDA," Dr. Malik says. "The company brought the replacement device in and after more problems were reported with the original, they recalled the older model knowing they had a replacement in the wings. -
Ethicon Physiomesh Lawsuit Springs from Medical Device Withdrawl
Nov 2, 2016 | Lawyers and Settlements
Orlando, FL It wasn’t that long ago that problems associated with transvaginal mesh commanded headlines and fueled lawsuits. Now the mesh is back, but this time stemming from a different indication. The complaints, however, are similar: allegations of early failure causing pain and other health implications for the patient, prompting many to file a Surgical Mesh lawsuit.
A recent Mesh lawsuit alleging problems with Physiomesh – a now-withdrawn product used in laparoscopic and incisional hernia surgery and manufactured by Ethicon Inc. – was filed September 22 in US District Court, Middle District of Florida. The Surgical Mesh lawsuit plaintiff underwent a procedure to repair a hernia in 2014 using the Physiomesh product. After complaints of persistent pain, a second procedure was attempted a year later to remove the Physiomesh. The surgeon, according to the Mesh lawsuit, was unable to remove all of the Physiomesh from the plaintiff’s abdomen due to debris from the failing mesh having become stuck to the plaintiff’s abdominal wall and bowels – leaving the plaintiff with ongoing Surgical mesh complications.
It should be noted that according to court documents the initial hernia repair was identified as an ‘incisional’ procedure, as opposed to laparoscopy.
The Surgical Mesh Complications identified by the plaintiff in the September Surgical Mesh lawsuit is eerily similar to reports of mesh problems associated with many a Transvaginal mesh lawsuit – in sum, mesh that becomes entangled in organs, tissue or protrudes into the vagina, with early rates of failure.
As reported last month by LawyersandSettlements.com writer Heidi Turner, Ethicon Physiomesh Flexible Composite Mesh products were witdrawn by the manufacturer in May, with Ethicon extending an offer of a full refund to healthcare facilities and medical professionals for returned product by September 16.
That deadline has now passed. The Florida lawsuit was filed six days later, on September 22.Turner reported that two unpublished studies – undertaken by the German and Danish Medical Registries – found early failure rates for Ethicon Physiomesh. The product was found to break down too early, potentially allowing hernias to reoccur, or introducing the potential for bacterial infection.
The Florida Physiomesh lawsuit cites use of Physiomesh Product Code PHY2025V, a product code that was included in the product codes identified in the recent Physiomesh recall.
The Florida complainant alleges that the Physiomesh Flexible Composite Mesh device she received was defectively designed and manufactured. Her Surgical Mesh lawsuit asserts that the Plaintiff is likely to suffer pain and medical complications for the remainder of her life.
The Surgical Mesh Complications lawsuit is Case No. 6:16-cv-01663-PGB-DAB, in US District Court, Middle District of Florida. The plaintiff is identified as Joanne Quinn. The defendants are identified as Ethicon, Inc. and Johnson & Johnson, both of New Jersey -
Nov 10, 2016 | Gary S. Logdson Associates
View video here: https://www.youtube.com/watch?v=IWDb-F4bpg0
Rough Transcript: Attention hernia repair patients Ethicon, a subsidiary of Johnson & Johnson, voluntarily withdrew its Physiomesh product used in hernia repair procedures. If you had hernia surgery from 2010 May 26th 2016 and suffered chronic pain, infection, internal damage, hernia recurrence or the need for corrective surgery, you may be entitled for compensation for the harm caused. Call Gary S. Logson Associates at 270-597-2134, call 270-597-2134.
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Lawsuit Alleges Ethicon Physiomesh Led to Significant Injury
Dec 1, 2016 | Injury Lawyer News
By Whitney Taylor
A plaintiff filing a lawsuit against Ethicon claims the company’s Physiomesh flexible composite hernia mesh led to serious injuries after he was treated for hernia repair.
In addition to recurrence of his hernia, the plaintiff has suffered significant and permanent injuries as well as the need for additional corrective surgeries. He is suing Ethicon for manufacturing a faulty device and failing to warn the medical community and general public about the risks associated with the hernia mesh.
Plaintiff cites hernia recurrences
David Watring filed his complaint in U.S. District Court in Massachusetts on November 12. Watring claims he underwent parastomal hernia repair using the Ethicon Physiomesh device on April 11, 2013 at Falmouth Hospital in Massachusetts. By November of that same year, Watring states his hernia had recurred and he was admitted to Falmouth Hospital once again for repair. This time, the hernia contained loops of the small bowel, a complication not seen prior to the original hernia repair.
In March 2016, Watring presented at Falmouth hospital once again with a recurrence of his parastomal hernia. During this surgery, small loops of bowel were once again discovered in the hernia, along with adhesions between the loops. The surgical repair took “an extensive amount of time” in order to make all of the necessary repairs. Despite the intricate care taken during this third surgery, the hernia has recurred once again and the plaintiff is now waiting to see if another surgical procedure will be necessary or even feasible.
Throughout the numerous surgeries Watring has undergone, he has also experienced both physical and mental pain and suffering and “substantial physical deformity.” He further alleges he has experienced financial setbacks due to the mounting medical bills and lost wages from his inability to work periodically because of his injuries.
Problems with the Ethicon Physiomesh
The Ethicon Physiomesh flexible composite hernia mesh was introduced to the U.S. market in 2010, primarily for hernia repair. The polypropylene mesh used to create the device was touted as inert and safe for placement in the human body. However, mounting evidence suggests the material is actually not biocompatible and can create an immune response within the body. The mesh can also fail to incorporate into the abdominal wall as it was designed to do, which can result in additional corrective surgery for patients.
Earlier this year, Ethicon voluntarily recalled the Physiomesh flexible composite hernia mesh due to a high rate of revision surgeries and hernia recurrences. The recall, which was issued on May 25, included a return of all unexpired products to the manufacturer. Ethicon stated they chose to recall the mesh after failing to pin down the cause of the high failure rate and could not issue any additional instructions for surgeons to lower that rate.
Hernia mesh lawsuits follow recall
Since the recall, patients who suffered injuries associated with the mesh have begun filing lawsuits against Ethicon in courts across the country. Like Watring, these plaintiffs are alleging the company marketed and distributed a faulty product without disclosing the risks associated with it. The first trial has now been scheduled for one of these lawsuits in early 2018, which may provide insight into how future lawsuits may be handled and decided.
In his complaint, Watring has listed numerous counts against Ethicon, including unjust enrichment, failure to warn and gross negligence and intentional conduct. He is seeking compensatory damages for pain and suffering, permanent impairment, loss of enjoyment of life and economic losses.
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Dec 12, 2016 | Legal Examiner
By Craig Kelley
In June of 2016 manufacturer, Ethicon, subsidiary of giant Johnson & Johnson, began to voluntarily recall the surgical mesh for hernias called Physiomesh. The product is a flexible composite mesh and it was found that revisions were needed in a large number of hernia repairs using Physiomesh. This recall was helpful in keeping the product from being used with patients in surgeries after the recall, but was of no good for those already having surgery with Physiomesh and suffering consequences. In fact, it has been estimated that as of November, 2016 300,000 Physiomesh implants might have been placed after its approval by the U.S. Food and Drug Administration in 2010!
Complications from Physiomesh has been seen as infection within and also around the mesh once it’s implanted. This can cause abdominal abscesses, intestinal fistula, bowel obstruction, and possible other complications. Complications have required major surgery in patients, while not correcting the original pre-surgical diagnosis. There have been at least 650 Adverse Event Reports to the FDA with no real consequences to Ethicon. It is expected that this will result in a very large number of lawsuits and a motion for Multidistrict Litigation (MDL) to consolidate all of the cases and fight the giant Ethicon.
If you or a loved one has been injured by Physiomesh, or any medical device, drug, or other product, consult your medical provider and please contact Inserra Kelley Sewell, Personal Injury Attorneys, to discuss your potential justice and entitlement to compensation for your damages.
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Johnson & Johnson’s Ethicon Composite Physiomesh Recalled
Dec 13, 2016 | Seeger Weis LLP
Ethicon, a subsidiary of the medical products giant Johnson & Johnson, is facing what may be only the first of multiple lawsuits to be filed for injuries caused by its Ethicon Physiomesh Flexible Composite Surgical mesh.
The Ethicon Physiomesh Flexible Composite surgical mesh was approved in 2010 for implantation through a laparoscopic procedure. A May 2016 recall of the device was prompted by analysis of two separate databases that keep record of hernia statistics. Examination of the Herniamed German Registry and Danish Hernia Database showed that patients who received the Ethicon Physiomesh Composite mesh had a higher-than-expected recurrence rate or requirement for reoperation as compared to patients who received other types of surgical mesh. The recall involved all lot numbers of the device, and the company has stated it will not reintroduce the product.
The first lawsuit against Johnson & Johnson and its Ethicon unit was filed in September 2016 by a Florida woman who received the mesh as part of a 2014 hernia repair. One year later, she had experienced severe complications involving the bowel, with recurrence of the hernia. The device was found to have become stuck to the abdominal walls, causing intestinal obstruction and requiring a reoperation hernia surgery. The federal lawsuit, filed in the U.S. District Court for the Middle District of Florida, Orlando Division, is likely to be the first of many the company may be facing. Two other lawsuits have also been filed in federal courts in Illinois and Massachusetts.
Hernia is a condition that develops when fibers of the trunk muscles “split,” potentially allowing internal organs to bulge through the muscle layer. This results in severe pain and may pose serious medical risks. The Ethicon Physiomesh was intended to be implanted laparoscopically to give the abdominal wall additional support for hernia repair. Unfortunately, patients who received the Ethicon product may have had a recurrence of their hernia. A second repair or reoperation may have put these patients at risk of additional pain, infection, and other surgical complications.
Complications that might result from failure of the mesh may include:
Severe pain
Abdominal swelling
Bowel obstruction
Bowel adhesion
Mesh migration
Bacterial infection
Organ obstruction
Hernia recurrence
Reoperationrequirement
The first Ethicon Physiomesh Composite lawsuit has been filed in federal court in Florida but many more lawsuits may be expected as more injuries come to light.
If you or a loved one received a laparoscopically implanted Ethicon Physiomesh Flexible Composite surgical mesh between March 2010 and May 2016 for a ventral (abdominal) hernia and experienced severe complications, you may be eligible for compensation for medical costs, lost wages and pain and suffering and should seek legal expertise.
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Olinde & Mercer LLC Television Ad
Dec 14, 2016 | Olinde & Mercer LLC
View Clip Here: https://www.ispot.tv/ad/Aace/olinde-firm-ethicon-physiomesh#
Rough Transcript: Attention hernia repair patients, Ethicon voluntarily withdrew its Physiomesh products used in hernia repair procedures. If you had laparoscopic hernia surgery between 2010 and May 26, 2016 and suffered hernia recurrence or the need for corrective surgery you may be entitled to compensation for the harm caused. If you had hernia recurrence or corrective hernia surgery call 1-800-777-8544, for a free consultation, call 1-800-777-8544.
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Hernia Mesh Complications Class Action Lawsuit Investigation
Dec 19, 2016 | Top Class Actions
Overview: Ethicon Hernia Mesh Recall
The Physiomesh Flexible Composite Mesh device was approved to be marketed by the U.S. Food and Drug Administration (FDA) in March 2010 through the federal agency’s 510k fast-track approval program. This program allows medical device makers to pursue approval of a product by showing that it’s “substantially equivalent” to a similar product, without the standard requirements such as testing and research.
Physiomesh hernia patch is described by Ethicon as a “sterile, low profile, flexible composite mesh designed for repair of hernias and other fascial deficiencies.” It is made with a macroporous polypropylene that is held together by two undyed polygelcaprone-25 films.
After its approval, the Physiomesh became a widely used hernia mesh product. However, it also became associated with more problems than expected after Ethicon’s hernia mesh product was used for laproscopic ventral hernia repair. Complications reported include hernia recurrence, removal surgery, infections, wound problems, and abdominal pain.
The recall of Ethicon’s Physiomesh Flexible Composite mesh announced in May 2016 was categorized as a “Market Withdrawal.” Ethicon failed to clearly define the factors behind the high failure rate. Ethicon said that the failure rate could be due to a several factors: hernia mesh design, the physician’s instructions, and patient selection.
Ethicon Hernia Mesh Lawsuits
Several hernia mesh lawsuits have been filed over failed Physiomesh hernia mesh products with some of the the following allegations:
· Failure to perform adequate research of the product
· Failure to warn about the complications linked to the product
· Providing misleading information about Physiomesh’s safety
· Defective instructions for surgeons
· Failing to recall the product once the problems were discovered
· Failing to make a safer mesh product.
If you underwent a hernia surgery and suffered severe hernia mesh side effects, your complications may be the result of a defective mesh product made by Ethicon. You may qualify to file a hernia mesh lawsuit. Learn more by filling out the form on this page for a free case evaluation.
In general, hernia mesh lawsuits are filed individually by each plaintiff and are not class actions. After you fill out the form, the attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you.
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Hernia Mesh Study Finds Higher Rate of Complications
Jan 3, 2017 | Top Class Actions
By Paul Tassin
According to a recent study, patients undergoing hernia surgery may face a risk of complications that may offset the benefits of hernia mesh.
The study was published by the Journal of the American Medical Association in October 2016.
While researchers reported that hernia meshsurgery patients generally had a lower risk of hernia recurrence over five years, the use of that mesh put those patients at risk for complications they would not have otherwise had.
Surgical mesh has been used for decades to repair hernias. Of the approximately 190,000 abdominal hernia surgical repairs performed in the U.S. in 2012, about half of them used a prosthetic mesh to support the repair.
In the JAMA study, researchers examined the records from over 3,200 patients who underwent elective surgery repair in Denmark between 2007 and 2010. Some of those surgeries involved the use of hernia mesh, and others used no mesh.
Over the five-year follow-up period, researchers noticed a number of mesh-related complications. Patients’ records showed reports of bleeding, late abscesses, bowel obstruction and bowel perforation.
The researchers reported that with mesh-based repairs, complications occurred at a rate of 5.6 percent for patients who underwent open surgery and at 3.7 percent for those who underwent laparoscopic surgery.
But patients who underwent non-mesh repair enjoyed a much lower complication rate of 0.8 percent, the researchers said.
The researchers pointed out that the complete spectrum of benefits and risks associated with hernia mesh is not fully known, thanks in part to an expedited FDA approval process.
According to the researchers, most mesh implants qualify for expedited FDA approval under what’s known as the 510(k) process. This process allows faster approval for new products that are similar to other products already on the market.
Products approved through this process aren’t subject to the same rigorous clinical trials that other, newer products have to go through. Because most mesh implants qualify for 510(k) approval, there’s less relevant clinical data about their risks and benefits, the researchers say.
Complications Get Ethicon Hernia Mesh Withdrawn from Market
One of the products approved through this expedited process ended up being taken off the market due to a high number of reports of complications.
In May 2016, Johnson & Johnson subsidiary Ethicon Inc. withdrew the Physiomesh Flexible Composite Mesh after more than six years on the market.
Patients who had been implanted with that particular mesh ended up undergoing follow-up surgery to fix complications at a rate that was higher than the manufacturer had expected.
Among the complications reported in conjunction with the Physiomesh were pain, swelling, adhesions, bacterial infections and migration of the mesh. In some cases, patients suffered from recurrence of their hernias, requiring further surgical repair.
Some patients who suffered complications after implantation with a Physiomesh implant have taken to the court system, arguing that Ethicon failed to properly warn them about the potential complications.
They challenge the instructions and warnings provided with the Physiomesh, and they claim that Ethicon left it on the market longer than it should have, even after reports of complications started rolling in.
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Jan 3, 2017 | Davis & Crump Television Ad
View Clip Here: https://www.ispot.tv/ad/AelP/davis-and-crump-pc-hernia-mesh-complications
Rough Transcript: This is important news for anyone who had hernia repair with mesh reinforcement and suffered injuries such as infection, chronic pain, movement or failure of the mesh, organ damage or needed additional surgery. If you or a loved one suffered from mesh used in hernia repair, call the law offices of Davis & Crump at the number below right now to find out if you are eligible for a cash award and medical expenses. Our first consultation is free and we don't get paid unless you get paid. Call now, operators are standing by.
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