Every medical device is assigned to one of three classes in the United States, based on the level of control that the Food and Drug Administration (FDA) has to exert to assure the device’s safety and effectiveness. The higher the class, the more risky a device may be.
Currently, transvaginal mesh patches are designated as Class II devices. The FDA announced, after a meeting in September 2011, that the organization is considering placing the mesh patches in the Class III category. This consideration is based on recommendations by the Obstetrics/Gynecology Devices Panel, as well as evaluation of related published literature and an assessment of the adverse event reports for transvaginal mesh.
What does this mean for the future of transvaginal mesh?
Our attorneys believe that this is yet another indication of the FDA’s concern over the severe complications associated with transvaginal mesh implants. The FDA recently ordered transvaginal mesh manufacturers to investigate the safety of the device. However, in the meantime, it is still being used, causing women continue to suffer painful and serious complications. The best way to prevent more women from being hurt is to continue to file lawsuits on behalf of injured women, hoping the claims will pressure manufacturers to remove the mesh from the market.
We are determined to obtain justice for women who have been harmed by this dangerous device by helping them file lawsuit claims against the manufacturers for compensation. No woman should have had to suffer after receiving transvaginal mesh. Contact us for more information today.
Information About the Classes of Medical Devices
Every medical device sold in the U.S. must fall into one of the three categories. Device classification is dependent on two factors: the intended use of the device (i.e. a pair of surgical scissors used to cut tissue) and the indications of use (a more specialized use for the device such as making incisions in the dermis). Additionally, the classification is risk-based, so the risk the device poses to the patient must be assessed. Class I is comprised of lowest-risk devices and Class III of most high-risk devices.
- Class I devices are not to be used in supporting or sustaining life; they cannot be of significant importance in preventing impairment of human life. Most importantly, they may not be linked to potential unreasonable risk of illness or injury.
- Class II devices are held to a higher level of guaranteed safety than Class I devices and are designed to be utilized without injury or harm to the patient.
- Class III devices usually are those that support or sustain life or are of great importance in preventing harm of human health. Class III devices may also include those that present a potential, unreasonable risk of illness or injury.
Class II vs. Class III for Transvaginal Mesh
One of the factors the FDA will use to determine the medical device classification of transvaginal mesh is risk evaluation. Several studies have been published regarding the adverse risks associated with transvaginal mesh when the device is used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Additionally, the FDA has received over 3,800 reports of significant complications associated with the mesh patches. The FDA will rely on the published studies, the adverse event reports and the recommendations of the medical community to determine the classification and continued availability of transvaginal mesh implants.
What Do You Think?
Do you think the transvaginal mesh implant issues warrant putting the device in Category III? Leave your thoughts in the comments below.