Philips announced a voluntary recall of some of its sleep and respiratory care devices in mid-June. The U.S. Food and Drug Administration (FDA) announced the…
Read MoreHernias 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.
For a free consultation and more information about your legal options, please contact us today.
Get a Free Case ReviewSome 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.
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.
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.
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.
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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)
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.
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.
Weitz & Luxenberg holds a seat on the Plaintiffs’ Steering Committee. David Rosenband Esq. of Weitz & Luxenberg is working closely with the Plaintiffs’ Steering Committee in the multidistrict litigation against Ethicon.
We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.
(833) 544-0604Over the years, Bard, Inc., has manufactured a number of mesh devices intended for use in hernia repair. The company claims that the different models offer surgeons options, depending on the unique circumstances of each patient.
However, patients, their families, their doctors, or attorneys have reported adverse reactions to the FDA related to certain Bard products.
Complications of Bard hernia mesh listed in the FDA MAUDE database related to various models include, but are not limited to(9) (10) (11) (12) (13):
Issues with each of the below models have been reported according to the FDA MAUDE database:
3DMax Mesh: Bard, Inc. issued a voluntary Class 3 recall for 3D Max Mesh in 2008 because of the mislabeling of anatomically shaped pre-formed polypropylene mesh designated use in the repair of hernias or chest wall defects on either the right or left side of the human body.(14)
Sepramesh IP Composite: In recent years, the MAUDE database provides information about a number of adverse events regarding Sepramesh IP mesh.(15)
Composix E/X Mesh: At least one patient allegedly had numerous adverse reactions to Composix E-X mesh. He is suing.(16)
“The following was reported … by the patient’s attorney: … the patient underwent implant of a composix e/x mesh to treat a recurrent incisional hernia.” Subsequently, “the patient was allegedly diagnosed with ‘infected mesh’ and required a subsequent surgery to remove the composix e/x. The surgeon excising the mesh alleged that the patient had ‘multiple adhesions to his abdominal wall,’ and performed lysis of adhesions allegedly caused by the composix e/x mesh. The attorney alleges the patient experienced infection, additional surgery, adhesions, permanent injury, defective mesh and explant.”(17)
Ventralex ST Hernia Patch: Complaints regarding Ventralex ST Hernia Patch include pain and adhesions. The physician of one patient specifically reported a number of adverse events to the MAUDE database. “It was reported … the patient was implanted with a bard ventralex st hernia patch. Following implant it is reported that the patient developed a non healing, draining wound overlying the mesh with pain and overall fatigue. There was a concern for mesh infection. … the patient was brought to surgery for a laparoscopic procedure. The mesh was found to have folded over with adhesions, including some to the bowel. The adhesions were released, with no injury to the bowel and the procedure was then transitioned to open and the mesh was removed.”(18)
Bard Ventralex: Reports in the MAUDE database indicate a number of patients who received the Ventralex mesh have hired attorneys because of severe adverse events. In at least one instance, the attorney is continuing to pursue legal action, because, it is claimed, the client died due “in whole or in part by complications from the infected hernia mesh which was caused, or contributed to be caused, by the ventralex hernia patch.”(19)
That particular report states: In 2010, “the patient underwent surgery with implant of a bard ventralex hernia patch for the repair of an incisional ventral hernia.” In “2015 – patient had abdominal pain, nausea and vomiting and she was admitted to the hospital the next day. Over the next few months the abdominal pain continued … the patient was diagnosed with infected hernia mesh and the doctors determined that the ventralex hernia patch needed to be removed.” In “2015 – patient underwent surgery to remove an infected hernia mesh, including a transverse colon resection and a small bowel resection because the hernia mesh was densely adhered to the patient’s colon and small intestine.”(20)
Bard Visilex: According to the manufacturer’s Instructions for Use, “Visilex™ mesh is indicated to reinforce soft tissue where weakness exists.” Examples of intended use include “repair of hernia and chest wall defects”(21). Reports in the MAUDE database indicate a number of patients who received the Visilex mesh and reported complications, including that in one case, a patient reported that his prostatectomy for prostrate case was rendered impossible due to mesh complications.(22)
That particular report states: “In 2003, [patient] had bilateral inguinal hernia repair with mesh. Bard visilex mesh was used on his right and left sides. In 2008, [patient] presented with prostate cancer for a radical prostatectomy. Unfortunately, the anterior aspect of the bladder was very adherent to the mesh, and we were unable to get an adequate plane between the detrusor and the mesh. Because of this significant anterior adherence, the surgeon did not feel we could safely proceed with prostatectomy. The [patient] was closed and radiation therapy was recommended.”
The Genzyme Corporation created the original Genzyme Sepramesh IP. The firm was acquired by the large pharmaceutical company, Sanofi, in 2011. Bard has been manufacturing and marketing the Genzyme Sepramesh IP and other products since 2007. Bard has been developing new products for hernia repair using the Sepra bioresorbable coating technology.(23) (24)
The FDA has received adverse events reports about the mesh. Reports indicate it has had to be removed from some patients, with reports of patients experiencing adverse events such as infection and seroma.(25) (26)
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.”(27)
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.(28) (29)
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.
In at least one instance, Covidien Parietex surgical mesh was reported as linked with considerable pain, numerous complications following surgery, intestinal blockage, and hospitalization.(30)
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.(31)
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.(32)
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.(33)
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.”(34)
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.(35) (36)
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.(37)
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.(38)
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.(39) (40)
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.(41)
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.(42)
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.”(43)
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.(44)
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…”
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…”(45) 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.(46)
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.(47)
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.(48)
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.”(52)
FDA has categorized recalls into three classes:(53)
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.”
David L. Rosenband is an associate attorney in our Drug and Medical Device Litigation group. Part of the Weitz & Luxenberg family since 2001, his mission is to obtain justice on behalf of individuals who…
Read MoreDavid L. Rosenband will be happy to review your case.
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 (833) 544-0604 or fill out the contact form on this page and one of our representatives will be in contact with you shortly.