Pennsylvania Transvaginal Mesh Attorney Discusses the Meaning of FDA “Clearance”

The Food and Drug Administration (“FDA”) plays a significant role in monitoring the food we eat, the drugs we take, and the products we may use or have implanted into us.  More often than not, we hear about the FDA in terms of pharmaceutical drugs and medical devices.  The FDA is a government agency that evaluates new drugs and devices to evaluate whether or not those drugs and devices are safe and effective.  However, the FDA has limitations and must rely on pharmaceutical companies to help them reach the conclusion as to whether or not a product is safe.  The FDA cannot do it all, and it is the pharmaceutical company that is ultimately responsible for doing the necessary testing to demonstrate a product is safe for human use.

What Does FDA Approval Mean?

We have all seen television ads that make clear to the public that a particular drug has been “FDA-approved.”  Many of us rely on this standard as a finding that a particular drug is safe and effective.  As part of the FDA approval process, certain drugs and devices must be thoroughly tested and evaluated before the FDA will consider approving the drug or device.  After all, if something is proven to be safe through human testing, anyone considering taking a drug or having a medical device implanted will feel more comfortable knowing that the product has been tested on humans.

What is FDA “Clearance”?

Unlike approval, FDA clearance is a process that allows certain medical devices to be sold that do not go through the formal human testing that is required when a pharmaceutical company seeks to have a drug or device approved.  Instead, a pharmaceutical company must show the FDA that its product is substantially similar to another product already in the marketplace.  For example, if a pharmaceutical company wants to introduce a new transvaginal mesh product, it must demonstrate to the FDA that this new product is substantially similar to another mesh product already in the marketplace, and therefore, human testing is unnecessary.

While many people may place blame on the FDA for having such a process, it is not the FDA at the end of the day that is responsible for ensuring the products are safe – it is the responsibility of the pharmaceutical company.  It is somewhat like an “honor system” that has worked well for certain products in the marketplace, but this system has proven to be disastrous for women suffering the effects of defective transvaginal mesh products.

Transvaginal Mesh Products Are Cleared, Not FDA-Approved

It may come as a surprise to some readers that a vast majority of transvaginal mesh products that have harmed women have not undergone long-term testing on actual live women.  Even doctors implanting these products may believe such products are approved based on prior human testing, when in fact, little if any testing has been done on live humans.  Because very little testing was done before many transvaginal mesh products hit the marketplace, tens of thousands (if not hundreds of thousands) of women are experiencing complications and injuries that many doctors did not expect, and that the FDA itself may not have expected.

The FDA has issued numerous public health notifications regarding the complications associated with transvaginal mesh, requiring some pharmaceutical companies to undergo long-term studies to prove the products are safe and effective for implantation into women.  It is unfortunate that many women may have had transvaginal mesh implanted on the belief that the product was FDA-approved, and therefore actually tested on live women.  As such, pharmaceutical companies should be held responsible for the pain and suffering (both physical and emotional) that their transvaginal mesh products have needlessly caused over the course of the last decade, if not longer.

Contact Cordisco & Saile LLC Today to Schedule Your Free Consultation

If you have suffered injuries as a result of a transvaginal mesh product, you should consider contacting a Pennsylvania Transvaginal Mesh Attorney right away.  The injuries and complications associated with transvaginal mesh can get worse over time.  Additionally, you may have limited time to take legal action, so it is crucial that you act quickly if you believe you have been injured as a result of transvaginal mesh.  The Pennsylvania Transvaginal Mesh Attorneys of Cordisco & Saile LLC represent thousands of clients who have suffered at the hands of defective transvaginal mesh products, helping those clients seek and recover the compensation they deserve.  To schedule your free consultation, contact Cordisco & Saile LLC today by calling (215) 791-8911, or complete an online form on our Contact Us page.