Hernia Mesh Linked to Complications

A hernia occurs when part of an organ or tissue pushes through the wall of the body cavity containing it. This frequently happens when a weak spot in the muscles or connective tissue of the pelvic or abdominal wall allows for the intestines to protrude through.
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Hernias corrected by surgery can have a high recurrence rate. Since the 1980s, surgeons have increasingly relied on hernia mesh in an attempt to strengthen surgical repairs and prevent recurrences.

Some recent hernia meshes have been linked with increased risk of infections, adhesion, perforation or obstruction of the bowels, mesh migration, or a higher-than-expected rate of hernia recurrences requiring hospitalization and further surgeries.

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If you have suffered severe mesh complications requiring hospitalization or corrective surgery due to problems with the mesh used in your hernia repair surgery, you may be entitled to compensation for medical costs and other expenses. Weitz & Luxenberg offers a free consultation to help you understand your legal options.

Complications Occurring with Hernia Mesh

Collectively hundreds of adverse events have been reported to the U.S. Food and Drug Administration (FDA) related to several types of hernia mesh, including: Atrium Medical’s C-QUR; Ethicon Inc.’s Physiomesh Flexible Composite Mesh; certain types of Bard mesh such as the PerFix, 3DMax, Ventralex ST, Sepramesh IP Composite, Composix E/X; and certain types of Covidien mesh, such as the Parietex Surgical, Parietex Composite, and Parietex ProGrip.

All of the above meshes were approved through the FDA’s 510(k) process.  Manufacturers using this method do not have to provide safety or efficacy data to the FDA through clinical trials; they only have to show the new product is “substantially equivalent” to another device that the FDA has already approved.

Complications from Ethicon Physiomesh Flexible Composite Mesh, Atrium’s C-QUR meshes, and several types of Bard and Covidien hernia meshes have frequently required additional surgeries.

These complications have included:

  • Severe or chronic pain
  • Adhesion of the mesh to bowels
  • Bowel obstructions
  • Mesh failure
  • Perforation of the intestines
  • Migration from the surgical site
  • Seromas – pockets of fluid that build up under the skin
  • Fistulae

Weitz & Luxenberg wants to hear from people who have developed any of the above conditions following surgery in which Atrium C-QUR meshes, Ethicon Physiomesh Flexible Composite Mesh, or certain Bard or Covidien meshes were used. The firm also wants to talk to people who have had revision surgery to correct problems related to these hernia meshes and to people who have been advised by their doctor to have corrective surgery.

Atrium C-QUR Problems Reported to the FDA

Physicians or patients implanted with Atrium C-QUR mesh have reported the need for additional surgery to the FDA MAUDE (Manufacturer and User Facility Device Experience) adverse events database.

In one case, the patient reported that a surgeon had to remove previously healthy tissue, including previously healthy muscle tissue, because of the damage done by the C-QUR mesh, with the patient subsequently developing a life-threatening infection requiring prolonged hospitalization.(1) In another case, the MAUDE report stated that the patient’s C-QUR mesh had “totally detached” and partially blocked and “strangled” the colon after the mesh was implanted.(2)

In one case, the patient reported that a surgeon had to remove previously healthy tissue, including previously healthy muscle tissue, because of the damage done by the C-QUR mesh, with the patient subsequently developing a life-threatening infection requiring prolonged hospitalization.

Doctors have also reported infections or reactions after implanting C-QUR meshes in patients.(3) (4) One patient reported to the FDA Maude database that the patient’s surgeon stated that the area around the mesh “looked like a bomb went off” after the surgeon attempted surgery to remove the C-QUR mesh.(5)

Physiomesh Flexible Composite Mesh

Within months of first approving Physiomesh Flexible Composite Mesh, the FDA began receiving multiple reports of failures and recurring hernias requiring doctors to perform additional surgeries.

Failures and recurring hernias with physiomesh flexible composite mesh
In 2016, large hernia registries in Germany and Denmark also reported higher-than-average failure rates for the mesh.

In 2014, researchers with the Polish Hernia Study Group terminated a clinical trial involving Physiomesh and the Bard Ventralight ST due to severe adverse events. There was a high rate of hernias recurring and reoperations were necessary.(6) In 2016, large hernia registries in Germany and Denmark also reported higher-than-average failure rates for the mesh.(7)

In May, 2016, Ethicon removed Physiomesh Flexible Composite Mesh for laparoscopic surgeries from the global market.(8) The device removal decision affected only the Physiomesh Composite Mesh, and not the Open Flexible Composite Physiomesh.

If you have required hospitalization, revision surgery, or experienced pain or other symptoms related to problems with Ethicon’s Physiomesh Flexible Composite Mesh, speaking with an attorney can help you understand your legal options. Weitz & Luxenberg’s Drug and Medical Device Unit is prepared to help you.

We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.
(877) 680-3753

Bad Experiences with Covidien Mesh Reported to FDA

Medical product manufacturer Covidien has advertised its Parietex surgical mesh devices for use in hernia repair as dependable, stating in its brochure that surgeons and patients alike will be able to “depend on a secure and comfortable repair.”(9)

However, according to adverse events described in the FDA’s MAUDE database, some patients have experienced anything but security and comfort as a result of Parietex mesh implantation. In fact, patients have experienced not only severe pain but also device migration.(10) (11)

For each of the Covidien Parietex surgical mesh products below, serious adverse event reports have been submitted to the FDA’s MAUDE database. Pain due to the mesh complications is one of the most recurring problems, often necessitating revision surgery.

Covidien Parietex Surgical Mesh

In at least one instance, Covidien Parietex surgical mesh was reported as linked with considerable pain, numerous complications following surgery, intestinal blockage, and hospitalization.(12)

According to this report, a female patient underwent a laparoscopic inguinal hernia repair procedure. Her surgeon used Covidien Parietex surgical mesh to repair both the left and right sides.(13)

Following the procedure, the patient reportedly experienced sharp pains and an uncomfortable feeling in her hip, pelvis, and groin area. She also claimed that her right side hurt so much that she was not able to lift her leg to get in her car or bend over to tie her shoes.(14)

The report further says that the patient began experiencing worsening pain on her left side, describing the pain as feeling “like a brillo pad was breaking up into pieces under the surface” of her skin.(15)

The MAUDE report describes the patient’s excruciating pain and multiple complications. The severity of this injury to her health affected her work performance and regular daily activities, like playing with her kids. Ultimately, she was hospitalized for “intestinal blockage due to the hernia mesh.”(16)

Covidien Parietex Composite Mesh

Adverse events for Covidien Parietex Composite mesh reported to the MAUDE database include, but are not limited to, infected mesh, subfascial abscesses, revision surgeries, and nonhealing wounds with exposed mesh.(17) (18)

One report from a medical facility indicates a patient “underwent laparoscopic converted to open ventral hernia repair with mesh.” The description of this adverse event says the patient ultimately ended up with a nonhealing wound with exposed mesh.(19)

Because of additional complications, the patient went “back to the operating room on two occasions … for non-healing wounds, associated with persistent mesh.” Ultimately, he had the mesh removed.(20)

Covidien Parietex ProGrip Mesh

Reported adverse events for Covidien Parietex ProGrip mesh include constant, debilitating pain, pain not only near the implantation site but also upward to the belly button and downward to the foot, spasms. Revision surgeries have been reported.(21) (22)

In one instance, a patient reported adverse events to the FDA’s MAUDE database regarding Covidien Parietex ProGrip mesh. He said he had the mesh implanted to repair an inguinal hernia.(23)

According to the patient’s report, following surgery, he experiences constant pain in one testicle. Additional severe pain started “in his right groin and extends up to his belly button.” Pain went down the inside of his leg to the bottom of his foot.(24)

According to the patient, “His everyday living has been severely impaired.” In fact, he describes in his report that he is “basically disabled due to constant pain.”(25)

FDA Actions Regarding Atrium C-QUR Problems

Between 2009 and 2013, the FDA conducted four separate inspections of the New Hampshire facility where Atrium manufactured C-QUR hernia mesh. Each time, inspectors found violations of federal regulations.(26)

During one inspection, the FDA noted Atrium had failed “to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification…”(27)

During one inspection, the FDA noted Atrium had failed “to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification…”(27)  As an example, the FDA mentioned complaints of C-QUR mesh product infections that were closed without obtaining the pending sample culture results regarding the infections.

After the FDA sought a permanent injunction against Atrium in 2015, the parties entered into a Consent Decree of Permanent Injunction in which Atrium agreed to pay $6 million in equitable disgorgement and agreed to shut down production lines until Atrium complied with the specific federal regulations and stipulations specified the Consent Decree.(28)

Physiomesh Flexible Composite Mesh Complaints

By late 2016, six years after the FDA first approved Physiomesh Flexible Composite Mesh, hundreds of reports on the mesh were filed with the FDA’s MAUDE database of adverse events.(29)

A review of those complaints shows repeated references to Physiomesh failing in ways that allowed hernias to recur. These cases frequently required revision surgery to remove and replace the faulty mesh.(30)

Other complications of Physiomesh Flexible Composite Mesh listed in the FDA database include:

  • Pain from mesh folding or bunching up(31)
  • Failing to incorporate into the body(32)
  • Adhesions and painful inflammatory reactions(33)
Complaints given over physiomesh flexible composite mesh

Covidien Mesh and the FDA

So far, the FDA has not issued any recalls for Covidien Parietex mesh products. According to the FDA, “Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.”(34)

FDA has categorized recalls into three classes:(35)

A Class I recall is of the utmost importance and urgency. In these cases, “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

A Class II recall is issued when “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences” or “the probability of serious adverse health consequences is remote.”

A Class III recall involves products “not likely to cause adverse health consequences.”

How Weitz & Luxenberg Can Help

If you suffered complications such as infection, mesh failure, pain, bowel perforation or obstructions, or other conditions related to Atrium’s C-QUR meshes, Ethicon Physiomesh Flexible Composite Mesh, or certain Bard or Covidien meshes following hernia surgery, you may be entitled to compensation.

Weitz & Luxenberg has 30 years of experience litigating complex medical cases and has been instrumental in securing billions of dollars in verdicts and settlements for patients harmed by faulty medical devices.

While past performance is no guarantee of future success, Weitz & Luxenberg has the background and resources necessary to seek justice if you have suffered complications from defective medical products.

For a free consultation, call us at (877) 680-3753 or fill out the contact form on this page and one of our representatives will be in contact with you shortly.

  1. U.S. Food and Drug Administration. (2011, July 5). MAUDE Adverse Event Report: Atrium Medical Corporation Atrium C-QUR 4” x 6” Hernia Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2650980
  2. U.S. Food and Drug Administration. (2012, March 28). MAUDE Adverse Event Report: Atrium Medical Corp. C-QUR Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2519804
  3. U.S. Food and Drug Administration. (2014, February 18). MAUDE Adverse Event Report: Atrium Medical Corporation C-QUR Tachshield Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3687873
  4. U.S. Food and Drug Administration. (2014, June 29). MAUDE Adverse Event Report: Atrium Medical Corp, Atrium C-QUR Mesh, Hernia Mesh 8.9cm x 8.9 cm 3 ½ in X 3 1/2 in. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2639496
  5. U.S. Food and Drug Administration. (2011, December 12). MAUDE Adverse Event Report: Atrium Medical Corporation C-QUR MESH Coated with Omega-3 Fish Oil 7.5 X 12 cm Coated Hernia Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2394781
  6. ClinicalTrials.gov. (2014, September 5). Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02233569
  7. Ethicon. (2016, May 25). Urgent: Field Safety Notice; ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes) Retrieved from http://www.igz.nl/Images/IT1027122-Ethicon_PHYSIOMESH-algepublic._tcm294-375822.pdf
  8. U.S. District Court, District of New Hampshire. (2015, February 3). United States v. Atrium Medical Corp., et al., Complaint for Permanent Injunction. Retrieved from https://www.justice.gov/file/338866/download
  9. Parietex ProGrip™ Self-Fixating Mesh. (2010). Retrieved from http://www.medtronic.com/content/dam/covidien/library/us/en/product/hernia-repair/parietex-progrip-self-fixating-mesh-brochure.pdf
  10. U.S. Food & Drug Administration. (2017, March 13). MAUDE Adverse Event Report: Sofradim Production SAS Parietex, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6471436&pc=FTL
  11. U.S. Food & Drug Administration. (2017, May 9). MAUDE Adverse Event Report: Covidien/Sofradim Parietex Hernia Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6559912&pc=FTL
  12. U.S. Food & Drug Administration. (2017, March 13). MAUDE Adverse Event Report: Sofradim Production SAS Parietex Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6471436&pc=FTL
  13. Ibid.
  14. Ibid.
  15. Ibid.
  16. Ibid.
  17. U.S. Food & Drug Administration. (2015, November 19). MAUDE Adverse Event Report: Covidien Parietex Composite Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5418788&pc=FTL
  18. U.S. Food & Drug Administration. (2015, November 19). MAUDE Adverse Event Report: Covidien Parietex Composite Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5418789&pc=FTL
  19. U.S. Food & Drug Administration. (2015, November 19). MAUDE Adverse Event Report: Covidien Parietex Composite Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5418788&pc=FTL
  20. Ibid.
  21. U.S. Food & Drug Administration. (2013, February 4). MAUDE Adverse Event Report: Covidien Covidien Parietex ProGrip Hernia Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2943724
  22. U.S. Food & Drug Administration. (2014, December 30). MAUDE Adverse Event Report: Sofradim Parietex ProGrip Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4386930&pc=FTL
  23. U.S. Food & Drug Administration. (2013, February 4). MAUDE Adverse Event Report: Covidien Covidien Parietex ProGrip Hernia Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2943724
  24. Ibid.
  25. Ibid.
  26. U.S. Food and Drug Administration. (2012, October 11). Inspections, Compliance, Enforcement, and Criminal Investigations. Atrium Medical Corporation 10/11/12. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325084.htm
  27. U.S. District Court, District of New Hampshire. (2015, February 3). United States v. Atrium Medical Corp., et al., Complaint for Permanent Injunction. Retrieved from https://www.justice.gov/file/338866/download
  28. U.S. Department of Justice. (2015, February 3). District Court Enters Permanent Injunction Against New Hampshire Company and Senior Executives to Stop Distribution of Adulterated and Misbranded Products. Retrieved from https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-new-hampshire-company-and-senior
  29. U.S. Food and Drug Administration. (2017, April 30). MAUDE – Manufacturer and User Facility Device Experience. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=Ethicon&brandname=Physiomesh&eventtype=&reportdatefrom=1%
  30. U.S. Food and Drug Administration. (2017, April 30). MAUDE – Manufacturer and User Facility Device Experience. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=Ethicon&brandname=Physiomesh&eventtype=&reportdatefrom=1%
  31. U.S. Food and Drug Administration. (2012, July 23). MAUDE Adverse Event Report: Ethicon, Inc. Physiomesh Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2704678
  32. U.S. Food and Drug Administration. (2012, September 28). MAUDE Adverse Event Report: Ethicon, Inc. Physiomesh Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2799300
  33. U.S. Food and Drug Administration. (2012, June 15). MAUDE Adverse Event Report: Ethicon INC. Physiomesh Mesh, Surgical. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2639885
  34. U.S. Food & Drug Administration. (2009, June 24). Safety. Background and Definitions. Retrieved from https://www.fda.gov/Safety/Recalls/ucm165546.htm
  35. Ibid.

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