#Atrium Medical Sued Over C-Qur Hernia Mesh
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cassandradodds · 8 years ago
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Atrium Medical Sued Over C-Qur Hernia Mesh, Injury Claims Mount
Plaintiffs Allege C-Qur Mesh Caused Adhesions, Recurrence, Other Adverse Events
Lawsuits are being filed over the C-Qur (pronounced “secure”) hernia mesh manufactured by Atrium Medical. The C-Qur hernia mesh contains a fish oil coating; some plaintiffs allege that the coating caused adverse events such as an allergic reaction. Plaintiffs in the C-Qur litigation allege that the device is defective and presents a risk of infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Parker Waichman LLP is closely monitoring the Atrium C-Qur hernia mesh litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
U.S. District Judge Landya McCafferty is overseeing the Atrium Medical C-Qur multidistrict litigation (MDL) in New Hampshire. An MDL is a type of mass tort where similar lawsuits are gathered together in one court to make the legal process more efficient. By consolidating lawsuits with common questions of fact to one court before one judge, MDLs eliminate duplicate discovery and streamline other legal proceedings with the goal of quicker resolution.
The C-Qur MDL was established in December 2016. There were 21 lawsuits transferred into the MDL as of Jan. 17, 2017, court records show. Lawsuits in the MDL allege injuries from the Atrium C-Qur mesh, C-Qur TacShield and C-Qur V-Patch.
The fish-oil coating is intended as an anti-adhesion barrier. Adhesions are a post-surgical complication where the tissues and organs stick to each other due to the presence of scar tissue. Some plaintiffs in the litigation allege that the C-Qur is defective and caused adhesions, along with other injuries. Lawsuits are also filed on behalf of plaintiffs who suffered hernia recurrence (where the hernia returned) and intestinal blockage.
In some cases, plaintiffs allege that doctors tried to remove the mesh due to complications but were unable due to the buildup of scar tissue. Lawsuits allege that Atrium Medical failed to warn patients and physicians about the risks associated with the C-Qur hernia mesh.
Atrium Medical C-Qur Background
The C-Qur was approved via 510(k), a fast-track review process. When devices are approved through this route, manufacturers are required to prove “substantial equivalence” to a previously approved device. This means that the new product is at least as safe as an older device, referred to as a predicate. Companies do not need to conduct clinical testing to prove that the new product is safe and effective. The FDA has a separate, stricter process for this known as premarket approval (PMA).
Plaintiffs, experts, and safety advocates have questioned the use of 510(k) for certain products. The route was only intended for low and moderate-risk devices, but high-risk devices such as metal-on-metal hip implants were approved through 510(k) due to a regulatory loophole.
Atrium Medical received a warning letter from the FDA in 2012 citing manufacturing violations at the company’s facility. Due to these violations, the letter said, products including the C-Qur were adulterated. The agency noted the presence of foreign substances, including human hair, in the sterile mesh.
A recall was issued for the C-Qur Edge mesh in 2013 because the coating could stick to the inner lining of the packaging in humid conditions. The action was labeled as a recall, but the product was not removed from the market. Atrium Medical sent a letter to its customers notifying them of the issue. “The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve,” the letter said.
In October, JAMA published a study finding that the benefits of hernia mesh are partially offset by the risks. Authors commented on the fact that hernia mesh was approved through 510(k), noting the lack of clinical trial data. “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark,” the authors wrote.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/atrium-medical-sued-over-c-qur-hernia-mesh-injury-claims-mount/
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parkerwaichmanlaw · 8 years ago
Text
Atrium Medical Sued Over C-Qur Hernia Mesh, Injury Claims Mount
Plaintiffs Allege C-Qur Mesh Caused Adhesions, Recurrence, Other Adverse Events
Lawsuits are being filed over the C-Qur (pronounced “secure”) hernia mesh manufactured by Atrium Medical. The C-Qur hernia mesh contains a fish oil coating; some plaintiffs allege that the coating caused adverse events such as an allergic reaction. Plaintiffs in the C-Qur litigation allege that the device is defective and presents a risk of infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Parker Waichman LLP is closely monitoring the Atrium C-Qur hernia mesh litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
U.S. District Judge Landya McCafferty is overseeing the Atrium Medical C-Qur multidistrict litigation (MDL) in New Hampshire. An MDL is a type of mass tort where similar lawsuits are gathered together in one court to make the legal process more efficient. By consolidating lawsuits with common questions of fact to one court before one judge, MDLs eliminate duplicate discovery and streamline other legal proceedings with the goal of quicker resolution.
The C-Qur MDL was established in December 2016. There were 21 lawsuits transferred into the MDL as of Jan. 17, 2017, court records show. Lawsuits in the MDL allege injuries from the Atrium C-Qur mesh, C-Qur TacShield and C-Qur V-Patch.
The fish-oil coating is intended as an anti-adhesion barrier. Adhesions are a post-surgical complication where the tissues and organs stick to each other due to the presence of scar tissue. Some plaintiffs in the litigation allege that the C-Qur is defective and caused adhesions, along with other injuries. Lawsuits are also filed on behalf of plaintiffs who suffered hernia recurrence (where the hernia returned) and intestinal blockage.
In some cases, plaintiffs allege that doctors tried to remove the mesh due to complications but were unable due to the buildup of scar tissue. Lawsuits allege that Atrium Medical failed to warn patients and physicians about the risks associated with the C-Qur hernia mesh.
Atrium Medical C-Qur Background
The C-Qur was approved via 510(k), a fast-track review process. When devices are approved through this route, manufacturers are required to prove “substantial equivalence” to a previously approved device. This means that the new product is at least as safe as an older device, referred to as a predicate. Companies do not need to conduct clinical testing to prove that the new product is safe and effective. The FDA has a separate, stricter process for this known as premarket approval (PMA).
Plaintiffs, experts, and safety advocates have questioned the use of 510(k) for certain products. The route was only intended for low and moderate-risk devices, but high-risk devices such as metal-on-metal hip implants were approved through 510(k) due to a regulatory loophole.
Atrium Medical received a warning letter from the FDA in 2012 citing manufacturing violations at the company’s facility. Due to these violations, the letter said, products including the C-Qur were adulterated. The agency noted the presence of foreign substances, including human hair, in the sterile mesh.
A recall was issued for the C-Qur Edge mesh in 2013 because the coating could stick to the inner lining of the packaging in humid conditions. The action was labeled as a recall, but the product was not removed from the market. Atrium Medical sent a letter to its customers notifying them of the issue. “The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve,” the letter said.
In October, JAMA published a study finding that the benefits of hernia mesh are partially offset by the risks. Authors commented on the fact that hernia mesh was approved through 510(k), noting the lack of clinical trial data. “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark,” the authors wrote.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/atrium-medical-sued-over-c-qur-hernia-mesh-injury-claims-mount/
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cassandradodds · 8 years ago
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Injury Claims Mount over Ethicon, Atrium Medical Hernia Mesh Products
Ethicon Withdraws Physiomesh, Faces Lawsuits
Ethicon, a subsidiary of Johnson & Johnson, is facing litigation over its Physiomesh hernia mesh device. Plaintiffs allege that the hernia mesh is defective, and that Ethicon failed to warn of the risks. Ethicon withdrew Physiomesh from the market in 2016 due to a high rate of recurrence and reoperation.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
In an Urgent Field Safety Notice issued last May, Ethicon said two large, independent hernia mesh registries showed that the Physiomesh Flexible Composite Mesh was linked to higher rates of recurrence and reoperation. “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 company said.
“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,”
Following the withdrawal, Physiomesh injury claims were filed against Ethicon. The first Physiomesh trial is scheduled to begin Jan. 22, 2018. The suit is filed on behalf of a man who suffered an infection two years after receiving the hernia mesh. His infection led to other complications, including two abdominal abscesses and intestinal fistulas.
In addition to Physiomesh lawsuits in the U.S., CTV News reports that Ethicon faces a class action lawsuit in Canada. The suit alleges that the Physiomesh has a design defect, making it prone to contract, tear or migrate. Patients are subsequently at risk for injury, including infections, abscesses, perforations, adhesion formations and the need for additional surgery, the suit alleges. Adhesions are a type of surgical complication where tissues and organs can stick to each other while the patient heals.
Atrium Medical Sued over C-Qur Hernia Mesh
Hernia mesh lawsuits are also being filed against Atrium Medical. The company is facing mounting injury claims over the C-Qur (pronounced “secure”) hernia mesh. The C-Qur contains a fish oil, or omega-3 coating. Some lawsuits allege that the coating caused complications, such as an allergic reaction, in certain patients. The fish oil coating is intended as an anti-adhesion barrier. Atrium Medical C-Qur lawsuits also allege infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Atrium Medical C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL) in New Hampshire before U.S. District Judge Landya McCafferty. MDLs are a type of mass tort used to make complex litigation move along faster and more efficiently. Similar lawsuits are transferred to one court before one judge, eliminating duplicate discovery and streamlining the legal process.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the Atrium Medical hernia mesh MDL in December 2016. The MDL consolidates lawsuits over the Atrium C-Qur mesh, C-Qur TacShield and C-Qur V-Patch.
Hernia Mesh Approved via 510(k)
In the United States, hernia mesh products were approved through the U.S. Food and Drug Administration’s 510(k) process. When devices are approved through this fast-track route, manufacturers do not need to conduct clinical data showing that their products are safe and effective. Products cleared through 510(k) only need to be “substantially equivalent” to previously approved devices.
The FDA has a stricter approval process known as premarket approval (PMA), which does mandate clinical testing.
510(k) was used to approve certain controversial medical devices, including transvaginal mesh and metal-on-metal hip implants. As such, there has been debate about whether this route is appropriate for certain products.
One JAMA study, published October 2016, found that the benefits of hernia mesh are partially offset by its risks. Researchers noted a lack of clinical data because hernia mesh was approved through 510(k). The authors wrote, “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark,”
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/injury-claims-mount-ethicon-atrium-medical-hernia-mesh-products/
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parkerwaichmanlaw · 8 years ago
Text
Injury Claims Mount over Ethicon, Atrium Medical Hernia Mesh Products
Ethicon Withdraws Physiomesh, Faces Lawsuits
Ethicon, a subsidiary of Johnson & Johnson, is facing litigation over its Physiomesh hernia mesh device. Plaintiffs allege that the hernia mesh is defective, and that Ethicon failed to warn of the risks. Ethicon withdrew Physiomesh from the market in 2016 due to a high rate of recurrence and reoperation.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
In an Urgent Field Safety Notice issued last May, Ethicon said two large, independent hernia mesh registries showed that the Physiomesh Flexible Composite Mesh was linked to higher rates of recurrence and reoperation. “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 company said.
“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,”
Following the withdrawal, Physiomesh injury claims were filed against Ethicon. The first Physiomesh trial is scheduled to begin Jan. 22, 2018. The suit is filed on behalf of a man who suffered an infection two years after receiving the hernia mesh. His infection led to other complications, including two abdominal abscesses and intestinal fistulas.
In addition to Physiomesh lawsuits in the U.S., CTV News reports that Ethicon faces a class action lawsuit in Canada. The suit alleges that the Physiomesh has a design defect, making it prone to contract, tear or migrate. Patients are subsequently at risk for injury, including infections, abscesses, perforations, adhesion formations and the need for additional surgery, the suit alleges. Adhesions are a type of surgical complication where tissues and organs can stick to each other while the patient heals.
Atrium Medical Sued over C-Qur Hernia Mesh
Hernia mesh lawsuits are also being filed against Atrium Medical. The company is facing mounting injury claims over the C-Qur (pronounced “secure”) hernia mesh. The C-Qur contains a fish oil, or omega-3 coating. Some lawsuits allege that the coating caused complications, such as an allergic reaction, in certain patients. The fish oil coating is intended as an anti-adhesion barrier. Atrium Medical C-Qur lawsuits also allege infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Atrium Medical C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL) in New Hampshire before U.S. District Judge Landya McCafferty. MDLs are a type of mass tort used to make complex litigation move along faster and more efficiently. Similar lawsuits are transferred to one court before one judge, eliminating duplicate discovery and streamlining the legal process.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the Atrium Medical hernia mesh MDL in December 2016. The MDL consolidates lawsuits over the Atrium C-Qur mesh, C-Qur TacShield and C-Qur V-Patch.
Hernia Mesh Approved via 510(k)
In the United States, hernia mesh products were approved through the U.S. Food and Drug Administration’s 510(k) process. When devices are approved through this fast-track route, manufacturers do not need to conduct clinical data showing that their products are safe and effective. Products cleared through 510(k) only need to be “substantially equivalent” to previously approved devices.
The FDA has a stricter approval process known as premarket approval (PMA), which does mandate clinical testing.
510(k) was used to approve certain controversial medical devices, including transvaginal mesh and metal-on-metal hip implants. As such, there has been debate about whether this route is appropriate for certain products.
One JAMA study, published October 2016, found that the benefits of hernia mesh are partially offset by its risks. Researchers noted a lack of clinical data because hernia mesh was approved through 510(k). The authors wrote, “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark,”
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/injury-claims-mount-ethicon-atrium-medical-hernia-mesh-products/
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cassandradodds · 8 years ago
Text
Lawsuits Mount over Complications with Ethicon Hernia Mesh
Ethicon, a subsidiary of Johnson & Johnson (J&J) is being sued over its Physiomesh Composite Mesh used to repair hernias. Ethicon withdrew the product in May 2016 as a result of a high rate of hernia recurrence and reoperation. Plaintiffs maintain that the recalled mesh caused complications and that Ethicon neglected to warn about the risks.
Parker Waichman LLP is a national law firm with extensive experience and success representing clients in medical device litigation. The firm’s attorneys are available to answer questions from individuals seeking legal information and advice.
What is Physiomesh Flexible Composite Mesh?
Ethicon Physiomesh Flexible Composite Mesh is an implantable tissue-separating mesh designed to be physiologically compatible with the abdominal wall. It is made 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 and Drug Administration (FDA) in 2010 by way of the agency’s 510(k) program. This program does not require a device manufacturer to conduct human clinical trials, provided it can demonstrate that the new product is “substantially equivalent” to another device that was previously approved by the FDA.
The hernia mesh is designed for patients undergoing minimally invasive abdominal and groin hernia repair.
“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,” Ethicon said in its “Urgent Field Safety Notice.”
Hernia Mesh Lawsuits
Plaintiffs allege that the Ethicon Physiomesh caused complications and that Ethicon failed to warn patients or the medical community about the risks. One Physiomesh lawsuit was filed on September 22, 2016 in the U.S. District Court, Middle District of Florida. Ethicon is facing another lawsuit, filed in the Southern District of Illinois, which is slated to begin on January 22, 2018.
Canadian patients who have been injured by Ethicon’s Physiomesh Flexible Composite Mesh product have filed a class action against the device’s manufacturer. A class action lawsuit is filed on behalf of a group of people who have been in some way injured by the actions of a company.
Canadian patients allege the Ethicon hernia patch has design defects that may cause the mesh to contract, tear, or migrate, resulting in pain, infection, perforations, abscesses, adhesions, and other complications that require revision surgery to remove the mesh.
The Ethicon mesh became available in Canada in September 2010, but in June 2016, recalled Physiomesh was recalled after the J&J subsidiary learned that the recurrence and reoperation rates after hernia repair using the mesh were higher than the average rates of other meshes, according to a report on CTVNews.ca.
A global recall was issued by Ethicon after unpublished data from two European hernia registries reflected the higher average recurrence and revision rates in laparoscopic ventral (abdominal) hernia repair versus comparable meshes. Estimates suggest as many as 30,000 Canadians may have received Physiomesh Flexible Composite Mesh for hernia repair surgery.
Hernia Mesh Complications
Alleged injuries may include hernia mesh infection resulting in a need for revision surgery. Signs of hernia mesh infection may include inflammation, healing difficulty, warmth at the incision site and flu-like symptoms.
Other manufacturers are also facing hernia mesh lawsuits. Atrium Medical is being sued over injuries allegedly caused by its C-Qur (pronounced “secure”) hernia mesh. Lawsuits allege that the C-Qur hernia mesh caused complications and Atrium Medical neglected to disclose the risks.
Patient advocates and safety experts have questioned whether 510(k) is appropriate for certain devices, given that some products approved through this route have become controversial. Transvaginal mesh, for example, was cleared through 510(k). The FDA reclassified transvaginal mesh as high-risk, meaning the devices must now go through premarket approval (PMA).
Lawsuits Mount over Complications with Ethicon Hernia Mesh
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated federal lawsuits into a multidistrict litigation (MDL), where similar lawsuits are brought before one court and one judge. MDLs are created to streamline the legal process, eliminate duplicate discovery, and generally make complex litigation more efficient. On October 10, 2016, plaintiffs filed a motion to transfer lawsuits to the U.S. District Court, District of New Hampshire.
At least 15 Atrium Medical C-Qur lawsuits have been filed, according to court records. Plaintiffs allege injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, bowel obstruction, abnormal liver function, and dental problems.
Legal Advice and Information Regarding Mesh Implants
If you or someone you know suffered injuries associated with a hernia mesh product, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-mount-complications-ethicon-hernia-mesh/
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parkerwaichmanlaw · 8 years ago
Text
Lawsuits Mount over Complications with Ethicon Hernia Mesh
Ethicon, a subsidiary of Johnson & Johnson (J&J) is being sued over its Physiomesh Composite Mesh used to repair hernias. Ethicon withdrew the product in May 2016 as a result of a high rate of hernia recurrence and reoperation. Plaintiffs maintain that the recalled mesh caused complications and that Ethicon neglected to warn about the risks.
Parker Waichman LLP is a national law firm with extensive experience and success representing clients in medical device litigation. The firm’s attorneys are available to answer questions from individuals seeking legal information and advice.
What is Physiomesh Flexible Composite Mesh?
Ethicon Physiomesh Flexible Composite Mesh is an implantable tissue-separating mesh designed to be physiologically compatible with the abdominal wall. It is made 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 and Drug Administration (FDA) in 2010 by way of the agency’s 510(k) program. This program does not require a device manufacturer to conduct human clinical trials, provided it can demonstrate that the new product is “substantially equivalent” to another device that was previously approved by the FDA.
The hernia mesh is designed for patients undergoing minimally invasive abdominal and groin hernia repair.
“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,” Ethicon said in its “Urgent Field Safety Notice.”
Hernia Mesh Lawsuits
Plaintiffs allege that the Ethicon Physiomesh caused complications and that Ethicon failed to warn patients or the medical community about the risks. One Physiomesh lawsuit was filed on September 22, 2016 in the U.S. District Court, Middle District of Florida. Ethicon is facing another lawsuit, filed in the Southern District of Illinois, which is slated to begin on January 22, 2018.
Canadian patients who have been injured by Ethicon’s Physiomesh Flexible Composite Mesh product have filed a class action against the device’s manufacturer. A class action lawsuit is filed on behalf of a group of people who have been in some way injured by the actions of a company.
Canadian patients allege the Ethicon hernia patch has design defects that may cause the mesh to contract, tear, or migrate, resulting in pain, infection, perforations, abscesses, adhesions, and other complications that require revision surgery to remove the mesh.
The Ethicon mesh became available in Canada in September 2010, but in June 2016, recalled Physiomesh was recalled after the J&J subsidiary learned that the recurrence and reoperation rates after hernia repair using the mesh were higher than the average rates of other meshes, according to a report on CTVNews.ca.
A global recall was issued by Ethicon after unpublished data from two European hernia registries reflected the higher average recurrence and revision rates in laparoscopic ventral (abdominal) hernia repair versus comparable meshes. Estimates suggest as many as 30,000 Canadians may have received Physiomesh Flexible Composite Mesh for hernia repair surgery.
Hernia Mesh Complications
Alleged injuries may include hernia mesh infection resulting in a need for revision surgery. Signs of hernia mesh infection may include inflammation, healing difficulty, warmth at the incision site and flu-like symptoms.
Other manufacturers are also facing hernia mesh lawsuits. Atrium Medical is being sued over injuries allegedly caused by its C-Qur (pronounced “secure”) hernia mesh. Lawsuits allege that the C-Qur hernia mesh caused complications and Atrium Medical neglected to disclose the risks.
Patient advocates and safety experts have questioned whether 510(k) is appropriate for certain devices, given that some products approved through this route have become controversial. Transvaginal mesh, for example, was cleared through 510(k). The FDA reclassified transvaginal mesh as high-risk, meaning the devices must now go through premarket approval (PMA).
Lawsuits Mount over Complications with Ethicon Hernia Mesh
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated federal lawsuits into a multidistrict litigation (MDL), where similar lawsuits are brought before one court and one judge. MDLs are created to streamline the legal process, eliminate duplicate discovery, and generally make complex litigation more efficient. On October 10, 2016, plaintiffs filed a motion to transfer lawsuits to the U.S. District Court, District of New Hampshire.
At least 15 Atrium Medical C-Qur lawsuits have been filed, according to court records. Plaintiffs allege injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, bowel obstruction, abnormal liver function, and dental problems.
Legal Advice and Information Regarding Mesh Implants
If you or someone you know suffered injuries associated with a hernia mesh product, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-mount-complications-ethicon-hernia-mesh/
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parkerwaichmanlaw · 8 years ago
Text
Invokana, Atrium C-Qur Lawsuits Can Be Filed Directly into MDLs
Invokana, Atrium Medical C-Qur MDLs Move Forward
In medical device and drug injury litigation news, two separate federal multidistrict litigations (MDLs) involving the diabetes drug Invokana (canagliflozin) and the Atrium Medical C-Qur (pronounced “secure”) hernia mesh are moving forward. According to separate pretrial orders, plaintiffs suing over Invokana or the C-Qur hernia mesh in federal court can file directly into the MDL. In the Invokana MDL, plaintiffs allege that the diabetes drug caused kidney damage. Atrium Medical C-Qur lawsuits allege that the defective hernia mesh caused allergic reactions and other complications.
Parker Waichman LLP has decades of experience representing clients in product liability and personal injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a drug or medical device injury lawsuit.
When there are a growing number of lawsuits with common questions of fact, they are sometimes consolidated into a federal MDL. This is a type of mass tort, where the U.S. Judicial Panel on Multidistrict Litigation (JPML) transfers the cases to one court before one judge. Establishing an MDL is helpful for large, complex litigations because it streamlines the legal process and heads towards resolution more quickly than if each case was processed individually. For example, the discovery phase in an MDL will only take place once and apply to all lawsuits.
The JPML established the Invokana MDL is the U.S. District Court for the District of New Jersey before U.S. District Judge Brian R. Martinotti. Court records indicate that the MDL contains at least 126 Invokana lawsuits. The MDL was created in December 2016. Alleged injuries include diabetic ketoacidosis and kidney damage.
The Atrium Medical C-Qur MDL was also created in December 2016. C-Qur hernia mesh lawsuits are consolidated in the U.S District Court for the District of New Hampshire. U.S. District Judge Landya B. McCafferty is presiding over the litigation. At least two dozen lawsuits have been transferred into the MDL so far, court documents indicate. Allowing plaintiffs to file their lawsuits directly into the MDL makes the legal process more efficient. It means that cases do not have to be delayed by being transferred from other federal courts.
Invokana Lawsuits Allege Ketoacidosis, Kidney Injuries
Johnson & Johnson is facing Invokana lawsuits alleging that the diabetes drug caused kidney damage and ketoacidosis. Lawsuits allege that J&J was aware of these risks, but failed to warn patients or the medical community.
In June 2016, the U.S. Food and Drug Administration (FDA) strengthened the warning on Invokana and other diabetes drugs to warn about the risk of acute kidney injury. In patients with acute kidney injury, the kidneys stop working suddenly, resulting in the buildup of dangerous waste products. Symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet, regulators warned.
According to the FDA notification, the agency received 101 confirmable reports of acute kidney injury from the time canagliflozin was approved in March 2013 through October 2015.
In May 2016, the agency said that interim clinical trial data suggested an increased risk of amputations in patients taking canagliflozin.
Atrium Medical C-Qur Hernia Mesh Lawsuits Allege Complications
The C-Qur is a product used for hernia repair. Plaintiffs suing over the Atrium Medical C-Qur hernia mesh allege that the product is defective and caused injuries, including allergic reactions and other complications. Atrium C-Qur lawsuits allege that the company was aware of the risks but failed to warn patients or their physicians. Some plaintiffs allege injuries due to the fish-oil (omega-3) coating, which was designed as an anti-adhesion, anti-inflammatory barrier. Lawsuits allege that the hernia mesh presents a risk of infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Lawsuits also allege hernia recurrence, where the hernia returned after the mesh was implanted.
The FDA sent a warning letter to Atrium Medical in 2012 due to manufacturing violations. Regulators said that, as a result, products including the C-Qur hernia mesh were adulterated. The agency said that the sterile mesh contained foreign substances, including human hair.
In 2013, Atrium Medical recalled the C-Qur Edge mesh. The recall was launched because the coating can adhere to the inner lining of the packaging under humid conditions. “The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve,” the recall letter said. The hernia mesh was not removed from the market.
Plaintiffs in the Atrium Medical C-Qur litigation point out that the product was approved through 510(k), an FDA fast-track route that allows devices to be approved without substantial clinical testing. Products cleared through 510(k) only need to be “substantially equivalent” to a previously approved product. This means that the new product is at least as safe as the older product.
510(k) has provoked discussions about medical device safety because it was used to approved products that are now considered controversial, including transvaginal mesh and metal-on-metal hip implants.
Parker Waichman notes that other hernia mesh products, including the Ethicon Physiomesh, have also been cleared through 510(k). The Physiomesh was withdrawn from the market last year, and is also subject to product liability litigation.
In a JAMA study published in October, researchers commented that since hernia mesh was approved through 510(k), “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark,”
Filing a Drug or Medical Device Injury Lawsuit
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in filing a personal injury lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/invokana-atrium-c-qur-lawsuits-can-filed-directly-mdls/
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cassandradodds · 8 years ago
Text
Invokana, Atrium C-Qur Lawsuits Can Be Filed Directly into MDLs
Invokana, Atrium Medical C-Qur MDLs Move Forward
In medical device and drug injury litigation news, two separate federal multidistrict litigations (MDLs) involving the diabetes drug Invokana (canagliflozin) and the Atrium Medical C-Qur (pronounced “secure”) hernia mesh are moving forward. According to separate pretrial orders, plaintiffs suing over Invokana or the C-Qur hernia mesh in federal court can file directly into the MDL. In the Invokana MDL, plaintiffs allege that the diabetes drug caused kidney damage. Atrium Medical C-Qur lawsuits allege that the defective hernia mesh caused allergic reactions and other complications.
Parker Waichman LLP has decades of experience representing clients in product liability and personal injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a drug or medical device injury lawsuit.
When there are a growing number of lawsuits with common questions of fact, they are sometimes consolidated into a federal MDL. This is a type of mass tort, where the U.S. Judicial Panel on Multidistrict Litigation (JPML) transfers the cases to one court before one judge. Establishing an MDL is helpful for large, complex litigations because it streamlines the legal process and heads towards resolution more quickly than if each case was processed individually. For example, the discovery phase in an MDL will only take place once and apply to all lawsuits.
The JPML established the Invokana MDL is the U.S. District Court for the District of New Jersey before U.S. District Judge Brian R. Martinotti. Court records indicate that the MDL contains at least 126 Invokana lawsuits. The MDL was created in December 2016. Alleged injuries include diabetic ketoacidosis and kidney damage.
The Atrium Medical C-Qur MDL was also created in December 2016. C-Qur hernia mesh lawsuits are consolidated in the U.S District Court for the District of New Hampshire. U.S. District Judge Landya B. McCafferty is presiding over the litigation. At least two dozen lawsuits have been transferred into the MDL so far, court documents indicate. Allowing plaintiffs to file their lawsuits directly into the MDL makes the legal process more efficient. It means that cases do not have to be delayed by being transferred from other federal courts.
Invokana Lawsuits Allege Ketoacidosis, Kidney Injuries
Johnson & Johnson is facing Invokana lawsuits alleging that the diabetes drug caused kidney damage and ketoacidosis. Lawsuits allege that J&J was aware of these risks, but failed to warn patients or the medical community.
In June 2016, the U.S. Food and Drug Administration (FDA) strengthened the warning on Invokana and other diabetes drugs to warn about the risk of acute kidney injury. In patients with acute kidney injury, the kidneys stop working suddenly, resulting in the buildup of dangerous waste products. Symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet, regulators warned.
According to the FDA notification, the agency received 101 confirmable reports of acute kidney injury from the time canagliflozin was approved in March 2013 through October 2015.
In May 2016, the agency said that interim clinical trial data suggested an increased risk of amputations in patients taking canagliflozin.
Atrium Medical C-Qur Hernia Mesh Lawsuits Allege Complications
The C-Qur is a product used for hernia repair. Plaintiffs suing over the Atrium Medical C-Qur hernia mesh allege that the product is defective and caused injuries, including allergic reactions and other complications. Atrium C-Qur lawsuits allege that the company was aware of the risks but failed to warn patients or their physicians. Some plaintiffs allege injuries due to the fish-oil (omega-3) coating, which was designed as an anti-adhesion, anti-inflammatory barrier. Lawsuits allege that the hernia mesh presents a risk of infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Lawsuits also allege hernia recurrence, where the hernia returned after the mesh was implanted.
The FDA sent a warning letter to Atrium Medical in 2012 due to manufacturing violations. Regulators said that, as a result, products including the C-Qur hernia mesh were adulterated. The agency said that the sterile mesh contained foreign substances, including human hair.
In 2013, Atrium Medical recalled the C-Qur Edge mesh. The recall was launched because the coating can adhere to the inner lining of the packaging under humid conditions. “The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve,” the recall letter said. The hernia mesh was not removed from the market.
Plaintiffs in the Atrium Medical C-Qur litigation point out that the product was approved through 510(k), an FDA fast-track route that allows devices to be approved without substantial clinical testing. Products cleared through 510(k) only need to be “substantially equivalent” to a previously approved product. This means that the new product is at least as safe as the older product.
510(k) has provoked discussions about medical device safety because it was used to approved products that are now considered controversial, including transvaginal mesh and metal-on-metal hip implants.
Parker Waichman notes that other hernia mesh products, including the Ethicon Physiomesh, have also been cleared through 510(k). The Physiomesh was withdrawn from the market last year, and is also subject to product liability litigation.
In a JAMA study published in October, researchers commented that since hernia mesh was approved through 510(k), “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark,”
Filing a Drug or Medical Device Injury Lawsuit
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in filing a personal injury lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/invokana-atrium-c-qur-lawsuits-can-filed-directly-mdls/
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cassandradodds · 8 years ago
Text
First Ethicon Physiomesh Trial Scheduled for January 2018
Ethicon Faces Mounting Lawsuits Over Physiomesh Hernia Mesh
The litigation against Ethicon and parent company Johnson & Johnson continues to mount over the Physiomesh hernia mesh device, which was withdrawn from the market last May due to a high rate of recurrence and reoperation. The first Physiomesh lawsuit is slated to go to trial on Jan. 22, 2018.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
According to court records, the plaintiff had the Physiomesh implanted in 2013 to repair an abdominal wall hernia. The lawsuit states that the plaintiff experienced severe abdominal pain, fever, chills and redness on his abdomen two years later, prompting him to return to the hospital. The complaint states that the plaintiff suffered an infection, allegedly due to the defective nature of the Physiomesh.
The lawsuit states that the infection led to other complications, two abdominal abscesses and intestinal fistulas from the mesh. The plaintiff underwent another surgery to address these adverse events. The lawsuit alleges negligence, strict liability, and breach of warranty. The plaintiff also accuses Ethicon of making an “unreasonably dangerous and defective product”. Additionally, the suit alleges that Ethicon failed to adequately test the product before placing it onto the market.
Other lawsuits have also been filed over the Physiomesh, alleging that that hernia mesh is defective and caused injuries such as hernia recurrence (where the hernia returned) and adhesion, a surgical complication where the organs and tissues stick to one another after a surgery.
For example, court records show that a recent Physiomesh lawsuit was filed on Feb. 2, 2017 in the U.S. District Court for the Middle District of Georgia. The lawsuit is filed on behalf of a woman who suffered hernia recurrence and intestinal obstruction, allegedly due to the defects of the Physiomesh. The plaintiff had the hernia mesh implanted as part of an incisional hernia repair, and subsequently experienced pain, nausea, and vomiting. Due to complications, she underwent a second surgery.
The lawsuit alleges that the patient’s intestines ruptured through the mesh and caused intestinal blockage. “The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of” the plaintiff’s “intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of [her] intestines,” according to the complaint. Although surgeons tried to remove the mesh, portions of the material remain stuck inside her body.
Litigation mounted after Ethicon withdrew Physiomesh in May 2016. The company issued an Urgent Field Safety Notice citing a high rate of recurrence and reoperation with the Physiomesh compared to other devices in two large, independent hernia mesh registries. “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,” Ethicon stated.
“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,”
Parker Waichman notes that lawsuits are also being filed over other hernia mesh products, including: Atrium Medical’s C-Qur (pronounced “secure”), C.R. Bard‘s Sepramesh, C.R. Bard’s Ventralex ST Hernia Patch, and C.R. Bard’s 3DMAX Mesh.
Hernia mesh products were approved through the U.S. Food and Drug Administration’s (FDA) 510(k) process. This means that device makers did not need to conduct clinical testing to prove that their products are safe and effective prior to marketing them. Companies only need to prove that the new product is at least as safe as a previous device; this is known as “substantial equivalence”. The use of 510(k) has been criticized for certain medical devices. Many medical device injury lawsuits are filed over products that were approved via 510(k).
Atrium Medical Sued Over C-Qur Hernia Mesh
Substantial litigation is growing against Atrium Medical over its C-Qur hernia mesh. Plaintiffs allege that the hernia mesh is defective and causes injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, bowel obstruction and abnormal liver function. Some lawsuits allege injuries related to the mesh’s fish oil coating, including adhesions and allergic reactions.
Atrium Medical C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court, District of New Hampshire. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML). In an MDL, similar lawsuits are grouped together in one court to make legal proceedings more efficient.
Researchers Study Long-Term Complications Associated with Hernia Mesh
In October 2016, a study published in the Journal of the American Medical Association (JAMA) assessed the rate of complications in patients undergoing hernia repair. Researchers compared Danish patients undergoing repair with hernia mesh (looking at both open and laparoscopic procedures) to patients undergoing open repair without the use of mesh.
The JAMA study found that the benefits of hernia mesh are partially offset by the risk of long-term complications. The study involved 3,242 patients in Denmark undergoing hernia repair.
Although hernia mesh was associated with a lower rate of reoperation for recurrence, these patients also had increased rates of complications. “For the entirety of the follow-up duration, there was a progressively increasing number of mesh-related complications for both open and laparoscopic procedures,” the authors wrote.
“Among patients undergoing incisional repair, sutured repair was associated with a higher risk of reoperation for recurrence over 5 years compared with open mesh and laparoscopic mesh repair,” authors concluded. “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/first-ethicon-physiomesh-trial-scheduled-for-january-2018/
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parkerwaichmanlaw · 8 years ago
Text
First Ethicon Physiomesh Trial Scheduled for January 2018
Ethicon Faces Mounting Lawsuits Over Physiomesh Hernia Mesh
The litigation against Ethicon and parent company Johnson & Johnson continues to mount over the Physiomesh hernia mesh device, which was withdrawn from the market last May due to a high rate of recurrence and reoperation. The first Physiomesh lawsuit is slated to go to trial on Jan. 22, 2018.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
According to court records, the plaintiff had the Physiomesh implanted in 2013 to repair an abdominal wall hernia. The lawsuit states that the plaintiff experienced severe abdominal pain, fever, chills and redness on his abdomen two years later, prompting him to return to the hospital. The complaint states that the plaintiff suffered an infection, allegedly due to the defective nature of the Physiomesh.
The lawsuit states that the infection led to other complications, two abdominal abscesses and intestinal fistulas from the mesh. The plaintiff underwent another surgery to address these adverse events. The lawsuit alleges negligence, strict liability, and breach of warranty. The plaintiff also accuses Ethicon of making an “unreasonably dangerous and defective product”. Additionally, the suit alleges that Ethicon failed to adequately test the product before placing it onto the market.
Other lawsuits have also been filed over the Physiomesh, alleging that that hernia mesh is defective and caused injuries such as hernia recurrence (where the hernia returned) and adhesion, a surgical complication where the organs and tissues stick to one another after a surgery.
For example, court records show that a recent Physiomesh lawsuit was filed on Feb. 2, 2017 in the U.S. District Court for the Middle District of Georgia. The lawsuit is filed on behalf of a woman who suffered hernia recurrence and intestinal obstruction, allegedly due to the defects of the Physiomesh. The plaintiff had the hernia mesh implanted as part of an incisional hernia repair, and subsequently experienced pain, nausea, and vomiting. Due to complications, she underwent a second surgery.
The lawsuit alleges that the patient’s intestines ruptured through the mesh and caused intestinal blockage. “The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of” the plaintiff’s “intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of [her] intestines,” according to the complaint. Although surgeons tried to remove the mesh, portions of the material remain stuck inside her body.
Litigation mounted after Ethicon withdrew Physiomesh in May 2016. The company issued an Urgent Field Safety Notice citing a high rate of recurrence and reoperation with the Physiomesh compared to other devices in two large, independent hernia mesh registries. “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,” Ethicon stated.
“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,”
Parker Waichman notes that lawsuits are also being filed over other hernia mesh products, including: Atrium Medical’s C-Qur (pronounced “secure”), C.R. Bard‘s Sepramesh, C.R. Bard’s Ventralex ST Hernia Patch, and C.R. Bard’s 3DMAX Mesh.
Hernia mesh products were approved through the U.S. Food and Drug Administration’s (FDA) 510(k) process. This means that device makers did not need to conduct clinical testing to prove that their products are safe and effective prior to marketing them. Companies only need to prove that the new product is at least as safe as a previous device; this is known as “substantial equivalence”. The use of 510(k) has been criticized for certain medical devices. Many medical device injury lawsuits are filed over products that were approved via 510(k).
Atrium Medical Sued Over C-Qur Hernia Mesh
Substantial litigation is growing against Atrium Medical over its C-Qur hernia mesh. Plaintiffs allege that the hernia mesh is defective and causes injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, bowel obstruction and abnormal liver function. Some lawsuits allege injuries related to the mesh’s fish oil coating, including adhesions and allergic reactions.
Atrium Medical C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court, District of New Hampshire. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML). In an MDL, similar lawsuits are grouped together in one court to make legal proceedings more efficient.
Researchers Study Long-Term Complications Associated with Hernia Mesh
In October 2016, a study published in the Journal of the American Medical Association (JAMA) assessed the rate of complications in patients undergoing hernia repair. Researchers compared Danish patients undergoing repair with hernia mesh (looking at both open and laparoscopic procedures) to patients undergoing open repair without the use of mesh.
The JAMA study found that the benefits of hernia mesh are partially offset by the risk of long-term complications. The study involved 3,242 patients in Denmark undergoing hernia repair.
Although hernia mesh was associated with a lower rate of reoperation for recurrence, these patients also had increased rates of complications. “For the entirety of the follow-up duration, there was a progressively increasing number of mesh-related complications for both open and laparoscopic procedures,” the authors wrote.
“Among patients undergoing incisional repair, sutured repair was associated with a higher risk of reoperation for recurrence over 5 years compared with open mesh and laparoscopic mesh repair,” authors concluded. “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
from Parker Waichman http://www.yourlawyer.com/blog/first-ethicon-physiomesh-trial-scheduled-for-january-2018/
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