What Is The New FDA Transvaginal Mesh Classification?

This may not come as a shock to any of us, particularly people above retirement age, but the human design is flawed. Thankfully we have reached an age of medical technology where, if one of these flaws decides to afflict you, you’re not going to die in most cases.

This is true with an ailment called pelvic organ prolapse (POP), which effects women, particularly in their later years or after they’ve had children. POP happens when the muscles within the vaginal cavity that hold up the bladder and uterus weaken to the point that they can no longer adequately support the organs, thus causing them to sag, putting significant pressure on the area restricting the passing of urine and other complications such as pelvic organ prolapse and stress urinary incontinence.

Physical ailments such as POP are generally addressed with medical devices, like the transvaginal mesh or transvaginal sling. They are regulated by the Food and Drug Administration (FDA) and set into three general classes, Class I, II, and III. And it seems that the transvaginal mesh has a new designation, Class III due to the serious design flaws found in many of different products in the market.

FDA Transvaginal Mesh Reclassification

The FDA started out the new year with bad news for the manufacturers of the transvaginal mesh and transvaginal sling. They reclassified the device from Class II to Class III, which mandates postmarket surveillance studies to be performed by manufacturers of urogynecologic surgical mesh devices. This means that further approvals will be required to go through a trial of human testing prior to approval.

“Serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the agency wrote on its website, however, still confirming that the devices are needed. “It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.”

The FDA Classifications are:

Class I – General Controls

• With Exemptions
• Without Exemptions

Class II – General Controls and Special Controls

• With Exemptions
• Without Exemptions

Class III – General Controls and Premarket Approval

Transvaginal Mesh Complications

In 2010 alone, nearly 185,000 women underwent procedures. In July, an FDA report found a fivefold jump in deaths, injuries or malfunctions tied to the products. These changes come after several studies and thousands of reports of serious injuries associated with the devices such as:

• Vaginal mesh erosion
• Pain
• Painful sexual intercourse
• Infection
• Urinary problems
• Bleeding
• Organ perforation
• Recurrent prolapse
• Neuro-muscular problems
• Vaginal scarring

The FDA issued 88 postmarket study orders to 33 manufacturers of transvaginal mesh for POP and 11 postmarket study orders to seven manufacturers of mesh mini-slings for stress urinary incontinence (SUI).

Device manufacturers who are not only faced with transvaginal mesh lawsuits, are now also required to submit study plans to the FDA that address specific safety and effectiveness concerns related to the surgical mesh devices. Data from the studies will enable the FDA to better understand the safety and effectiveness profiles of these devices.

Researchers from one study published in the journal Obstetrics and Gynecology reported that about 15% of the women treated with vaginal mesh experienced complications. Unlike the FDA, they concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.

The FDA approved of these devices under the controversial 510(k) approval process, which allows devices to be cleared for market, without any studies performed on patients, as long as they are “substantially equivalent” to existing products.

On November 21, 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a Joint Committee Opinion opining that due to the concerns about the safety and efficacy of the use of transvaginal mesh to treat pelvic organ prolapse (POP), it should be reserved for high-risk women for whom the benefit may justify the risk.

Defective Medical Device Lawyers

Defective medical devices can seriously effect a woman’s health and could possibly do permanent damage to vital internal organs. This could result in extensive hospitalization and a series of surgeries that may not have been required is the device had been properly designed and tested.

The defective design legal team at Phillips Law Firm has been following this issue since it was brought to the attention of the public nearly six years ago. Since then we have been prepared to answer questions and listen to the stories of real people affected by defective transvaginal meshes and slings. Call theDefective Device Attorneys at Phillips Law Firm for a consultation on how you can get the justice and compensation you deserve.

Real People. Real Justice. (800) 708-6000