Mazie Slater Katz & Freeman is investigating potential claims involving patients who suffered cerebrospinal-fluid leaks, graft deterioration, repeat hospitalization, or revision surgery after implantation of an Integra DuraFlex Suturable Dural Graft.

Reports submitted to the FDA describe DuraFlex grafts that allegedly developed marked thinning, easy tearing, central holes, deterioration, or dissolution. Some patients reportedly required additional surgery to repair a cerebrospinal-fluid leak or replace the graft. These reports do not, by themselves, establish that DuraFlex caused an injury or that every DuraFlex graft is defective. They do identify a pattern that warrants careful investigation.

Were you or a family member affected?

You should consider requesting a case review if:

You do not need to know the model number or lot number before contacting us. We can help determine what product was implanted by reviewing the hospital’s implant records.

The dura mater is the membrane that protects the brain and spinal cord and helps contain cerebrospinal fluid. When the dura is opened or damaged during surgery, a surgeon may implant a graft to close or repair the defect.

Integra describes DuraFlex as a natural, resorbable, collagen-based graft derived from bovine pericardium and intended to serve as a substitute for the repair of the dura mater. The product must be sutured into place.

Integra has promoted DuraFlex as a graft designed to:

Our investigation concerns whether some DuraFlex grafts may have lost their structural integrity too soon, before the patient’s own tissue could provide an adequate and durable closure.

A routine surgical complication and a defective graft are not necessarily the same thing. The location and physical appearance of the failure can be critical. A revision surgeon’s finding of a hole in the middle of the graft, marked thinning, easy tearing, friability, or apparent dissolution—particularly where the graft edges or suture line remained sealed—may justify a product-focused investigation.

The FDA’s public adverse-event database contains reports involving DuraFlex and related Integra bovine-pericardium dural grafts.

Examples include:

Hole in the center while the graft edges remained sealed

One FDA report states that a patient underwent surgery to correct a postoperative cerebrospinal-fluid leak. During the revision procedure, the surgeon reportedly found a hole in the middle of the DuraFlex graft even though the edges had sealed properly. The event was coded as a serious injury and material disintegration.

Marked thinning and easy tearing

Another report involving model BP10405 described deterioration near the suture line, focal dural dehiscence, marked thinning, and easy tearing of the surrounding graft material. The patient reportedly required hospitalization and additional intervention.

Grafts reportedly thinning or dissolving in the middle

A 2023 report described a patient whose first DuraFlex graft allegedly thinned and dissolved in the middle. A second DuraFlex graft reportedly weakened in its middle during implantation, and a third reportedly dissolved centrally and was explanted. The manufacturer identified a number of possible patient, surgical, and postoperative explanations and stated that an external cause was more plausible based on the information available.

These reports are significant enough to investigate, but they must be interpreted carefully. The FDA explains that adverse-event reports may be incomplete, inaccurate, unverified, duplicative, or affected by reporting bias. The reports cannot establish how frequently an event occurs and do not prove that a medical device caused a particular injury.

A product-liability review may be appropriate when the medical records document one or more of the following:

Physical findings involving the graft

Resulting medical complications

Not every patient with one of these complications has a valid product-liability claim. The firm must review the medical records, operative technique, location of the failure, timing, infection history, intracranial or spinal-fluid pressure, patient risk factors, and possible alternative causes.

In many cases, the original postoperative diagnosis will simply say “CSF leak,” “pseudomeningocele,” or “wound complication.” Those terms do not reveal why the closure failed.

The revision operative report may state whether the surgeon actually saw:

A central defect with intact edges may present a very different product-liability question from a leak caused by a loose suture or inadequate overlap.

Patients are often not told the brand or lot number of every surgical product used during an operation.

The identity of the graft may appear in:

Relevant descriptions may include:

Do not assume that a generic reference to a “dural patch” identifies the product. The implant log and product sticker usually provide more reliable identification.

Our preliminary DuraFlex review may consider:

A strong review does not merely ask whether a CSF leak occurred. It asks why the closure failed and what the surgeon actually observed.

When possible, patients and families should preserve or request:

Patients should not personally handle or attempt to retrieve biological material. Any preservation request should be directed through the appropriate hospital, pathology department, treating provider, or legal process.

Evidence can be discarded as part of routine hospital practice. Early investigation may therefore be important even when the patient has not yet decided whether to pursue a claim.

Cerebrospinal-fluid leakage is a recognized potential complication of dural surgery. The DuraFlex instructions also identify cerebrospinal-fluid leakage and surgical-site dehiscence among possible adverse reactions.

That does not necessarily answer why a particular leak occurred.

A leak may result from:

Our investigation focuses on distinguishing an expected surgical risk from evidence of premature material-integrity failure.

This investigation is not based on a representation that the FDA has recalled DuraFlex or formally declared it defective.

A case review instead considers:

Recall status is one consideration, but our evaluation does not depend on recall status alone.

Medical-device cases require more than proof that a patient experienced a bad result. They require product identification, preservation of physical evidence, review by qualified medical and engineering experts, analysis of regulatory records, and the ability to take on a sophisticated corporate defendant.

Mazie Slater Katz & Freeman represents injured patients in complex product-liability, defective-medical-device, medical-malpractice, and other serious civil cases. The firm’s attorneys have experience litigating difficult cases against major manufacturers and taking cases through trial.

Our investigation may include:

Start With Clarity

You do not need to determine for yourself whether the graft was defective. Tell us what happened, and we will evaluate whether the medical and product evidence warrants further investigation.

Do I need proof that DuraFlex was implanted before contacting the firm?

No. Tell us the hospital, surgeon, surgery date, and type of procedure. The product may be identifiable through the implant log, intraoperative record, billing record, or product sticker.

Does an FDA report prove that DuraFlex caused my injury?

No. FDA adverse-event reports are signals for investigation, not findings of legal or medical causation. The FDA cautions that reports may be incomplete or unverified and cannot establish an event rate. Each potential case must be independently evaluated.

What if my graft was not removed?

A claim may still be investigated. Medical records, imaging, operative findings, surgeon testimony, and the clinical course may provide relevant evidence. A preserved explant can be valuable, but it is not the only possible source of proof.

What if the hospital discarded the graft?

Contact the firm promptly. We can determine whether photographs, pathology material, retained samples, manufacturer correspondence, or other evidence exists.

What if infection was also present?

Infection can complicate the medical and legal analysis, but it does not automatically eliminate a potential case. The timing of the infection, condition of the graft, organism involved, surgical findings, and sequence of events must be examined.

What if the hole was close to the suture line?

A suture-line failure can have several possible causes, including technique, tension, graft handling, healing problems, mechanical stress, or material weakness. The operative report and expert review will be important.

Is there a deadline for bringing a claim?

Yes. Legal deadlines vary by state and by the circumstances of the case. Some deadlines may begin before a patient knows the full cause of the injury. Prompt review is important because both legal rights and physical evidence can be lost.

Should I wait until my medical treatment is finished?

You do not have to delay an initial legal review. Continuing treatment and protecting legal rights can occur at the same time. Medical decisions should be made with your treating healthcare providers, not based on information on this webpage.