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Integra LifeScience issued a voluntary recall of its Biologic Mesh implants. Manufacturing defects in these medical devices resulted in a failure to remove bacteria and their endotoxins from the collagen-based mesh.
Our law firm is investigating cases where patients suffered infections and, as a result, were hospitalized or died after receiving one of these implants:
To contact us for a free case evaluation, you can call us at (800) 277-1193. You also can request an evaluation by clicking Free & Confidential SurgiMend Mesh Evaluation Form. This form will be immediately reviewed by one of our attorneys handling the SurgiMend Mesh lawsuits.
Every case is different. Our attorneys will evaluate your injuries and losses to determine your recoverable damages in a SurgiMend lawsuit. Generally, the amount of compensation from a settlement or jury verdict depends on the type and extent of your injuries.
The types of damages you might recover if you were to file a lawsuit against mesh maker Integra LifeSciences include:
Defects in these biologic mesh implants can cause sepsis or infections that lead to death. If you lost a loved one who developed an infection from one of these medical devices, we are sorry for your loss.
Please know that you are entitled to pursue a wrongful death action. Our attorneys will guide you compassionately through this process.
In May 2023, Integra announced a recall of all products manufactured over the previous five years in the company’s Boston facility. An internal investigation revealed manufacturing issues that could have released implants containing endotoxin levels higher than what is allowed in manufacturer TEI Biosciences Inc.’s product specifications.
Endotoxins are a type of bacterial toxin. They can trigger immune responses that put patients at risk of serious, sometimes fatal, infections.
Integra LifeSciences is a global medical technology company headquartered in Princeton, NJ. The company offers regenerative technologies, specializing in surgical solutions, orthopedics, and tissue technologies.
In 2015, with an eye toward widening Integra’s platform for soft tissue reconstruction and wound repair, the company acquired TEI Biosciences Inc. and TEI Medical Inc for $312 million, according to NJBIZ.
TEI Biosciences manufactures SurgiMend Prs Meshed, Revize-X, and SurgiMend Mp Collagen Matrix for Soft Tissue Reconstruction. TEI signed an exclusive supply agreement with Stryker Howmedica Osteonics, Stryker’s orthopedic implant division. Under the terms of the agreement, TEI provides and distributes Stryker’s surgical mesh.
According to Integra’s 2020 Annual Report, the company’s full-year revenues are $1.37 billion.
The U.S. Food & Drug Administration has issued multiple warning letters to Integra regarding the deficiencies in their Quality Management Systems that triggered the recall of the company’s biologic mesh implants.
As of May 22, 2023, Integra had received 82 complaints for which endotoxin could have contributed to patient injuries and symptoms. Fifty-three of these complaints were deemed reportable to the FDA and prompted the recall.
The recall primarily affected Integra’s tissue products, including the company’s SurgiMend, PriMatrix, and ReVize collagen matrix products distributed from March 1, 2018, to May 22, 2023.
The May recall pertained to multiple Integra biologic mesh products as indicated in the company’s Medical Device Recall Notice.
In August 2023, following another inspection of TEI Biosciences’ medical device operations, the FDA issued a warning letter to Integra LifeSciences.
According to the letter, the FDA’s inspection uncovered that Integra’s collagen-based medical devices are “adulterated” under the terms of section 501(h) of the Act, 21 U.S.C. § 351(h). FDA’s warning conveyed the following violations:
2019: Integra released a lot of devices with bacterial endotoxin (BET) in amounts that exceeded the manufacturer’s acceptance criteria. FDA expressed concern that the company had not identified corrective actions in their quality system to ensure the facility would not repeat such a release of BET-adulterated devices in the future.
2022: An internal complaint alleged quality issues in various aspects of Integra’s manufacturing operations, including:
Integra did not open a Corrective Action and Prevention Action (CAPA) to address the endotoxin concerns, according to the FDA’s Warning Letter.
Although Integra placed a hold on affected lots, the company did not identify what potential impact could be had on lots that were manufactured during the same time period.
2023: Integra initiated a health hazard evaluation to address the endotoxin issues, but the FDA stated this effort failed to include all health risk concerns, including two complaints of meningitis.
The FDA stated that as of the Warning Letter’s issuance, Integra still had not adequately validated a method for testing bacterial endotoxin of finished medical devices.
The agency further noted that Integra failed to properly store implantable devices in a way that could assure their sterility.
Over the years, the FDA inspections of Integra’s manufacturing facilities have noted several substandard conditions, including these noted in a 2011 inspection:
The federal agency underscored Integra’s legal responsibility to conduct internal self-audit to identify and correct quality system requirements violations.
According to the Cleveland Clinic, the purpose of a surgical mesh is to reinforce tissue or bone. Many mesh devices are made of polypropylene or polyester. However, biologic surgical mesh implants are made of acellular collagen from human, pig, or cow tissue.
Manufacturers decellularize this tissue resulting in a collagen matrix that serves as a regenerative framework, according to research published in Clinics in Colon and Rectal Surgery medical journal. The purpose of these devices is to “replace or augment a patient’s native tissue when it has been compromised,” researchers explained.
Exposure to endotoxins in Integra’s recalled biologic mesh products could cause multiple types of complications and risks to health, including:
When your body improperly responds to an infection, it can cause damage to your organs and tissues. This is called sepsis.
Mayo Clinic outlines several symptoms of sepsis:
Bacteria that move into the bloodstream can cause sepsis, which can evolve into septic shock. If you experience septic shock, your blood pressure will drop dramatically. It could be fatal.
These are the symptoms of septic shock, per the Mayo Clinic:
Bacterial infection of the lungs can cause pneumonia, according to MedlinePlus, the National Library of Medicine’s medical database. Signs and symptoms of pneumonia include:
An infection of the membranes that surround the brain and spinal cord (meninges) is called meningitis. When the brain and spinal cord experience infections, the activated immune system can prompt inflammation.
The National Institute of Neurological Disorders and Stroke define the following signs of meningitis:
Each state enforces its own statute of limitations. This means you have a specific window of time from the date of your injury in which to file a civil lawsuit.
Our legal team knows the laws applicable to filing a biologic mesh lawsuit in your state and we will inform you of your rights to pursue a claim.
Levin Law