Frequently Asked Questions about OptiMesh / FAQ

Can I afford an OptiMesh lawsuit?
What are the FDA 510(k) premarket notifications?
How does the FDA define medical device?
Who invented OptiMesh?
Why is OptiMesh considered consumer fraud?
What are complications for vertebroplasty and kyphoplasty?
What is CE Marking?
In what states is Anapol Schwartz licensed to practice?

Can I afford an OptiMesh lawsuit?

Yes. If you decide to retain Anapol Schwartz and Anapol Schwartz agrees to be retained, then we will file an OptiMesh lawsuit on your behalf. You will have no out-of-pocket expenses because Anapol Schwartz will take your case on a contingency fee basis. What that means is if Anapol Schwartz doesn’t win your lawsuit, they do not get paid. With over 30 years experience in the field of personal injury, wrongful death, product negligence, and medical malpractice, Anapol Schwartz has more than 30 lawyers who are leaders in their field.

What are the FDA 510(k) premarket notifications?

The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

How does the FDA define medical device?

OptiMesh is considered a medical device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the body’s structure or function. The FDA warning letter says a company Web site and DVD promoted OptiMesh for an intended use that requires either an additional 510(k) or premarket approval submission.

Who invented Optimesh?

Dr. Stephen Kuslich, a pioneer in minimally invasive spinal surgery was at the helm. His vision was to create Spineology as a think tank where surgeons could come together to develop new ideas.

Why is OptiMesh considered consumer fraud?

Consumer fraud occurs when there is deception in advertising, sales, marketing, or provision of goods, services, or property. Fraud occurs when a person gives up some kind of property or legal right because they were intentionally deceived. Spineology, the manufacturer of OptiMesh led surgeons and hospitals to believe that their medical device could be used for procedures that that were never formally documented or approved.

What are the complications associated with vertebroplasty and kyphoplasty?

Complications for both vertebroplasty and kyphoplasty have included death, cardiac arrest, cement pulmonary embolism, paralysis from cement intrusion into the spinal canal, and pedicle fracture. Also, epidural hematoma, discitis, osteomyelitis, pneumothorax, hypotension, urine retention, and dural puncture have been reported with kyphoplasty. Allergic reactions and urine retention have been reported with vertebroplasty.

Much of the concern with vertebral augmentation has been cement leakage resulting in pulmonary embolism or spinal canal compression. The vast majority of cement leakage is asymptomatic. Another concern has been that alteration of spinal biomechanics after augmentation may lead to adjacent fractures.

In Europe, OptiMesh has a CE Marking and is approved for spinal interbody support. In the United States the FDA has not yet issued approval for spinal interbody support. What is a CE Marking?

CE Marking is a European marking of conformity that indicates that a product complies with the essential requirements of the applicable European laws or directives with respect to safety, health, environment and consumer protection. Generally, this conformity to the applicable directives is done through self-declaration.

In what states is Anapol Schwartz licensed to practice?

Anapol Schwartz is licensed to practice in Pennsylvania and New Jersey. Anapol Schwartz law firm has offices in Cherry Hill, New Jersey; Philadelphia, PA; Media, PA: Harrisburg, PA; and Reading, PA.

If you or a loved one has been seriously injured or paralyzed from OptiMesh surgery, please contact Anapol Schwartz. You may be eligible for a product liability OptiMesh lawsuit or medical malpractice lawsuit or both.