The Recall Lawyers

An Ohio woman has filed a case against Endo Pharmaceuticals and American Medical Systems (AMS) for injuries she sustained from the surgical implantation of an Elevate Prolapse Repair System. The case has been filed in the U.S District Court in Philadelphia.

This system was designed to treat pelvic organ prolapse, a condition that can occur in women following multiple childbirths.

AMS advertises the system as "a Total Transvaginal Approach to Prolapse Repair Requiring Just a Single Incision." The product website boasts minimal tissue trauma and shorter recovery periods.

The lawsuit alleges that the plaintiff has experienced unspecified pain, suffering and permanent injury since undergoing the surgery implanting the mesh device. Transvaginal surgical mesh devices have been associated with severe complications and in rare occasions have been linked with death.

Generally, the case against these manufacturers has been based on a lack of FDA oversight and a lack of premarketing testing.

Corey Ann Finn of Jones Ward PLC has experience with cases involving transvaginal mesh products. If you wish to discuss your potential claims that may arise from the surgical implantation of transvaginal mesh, please send her an email at corey@jonesward.com.

Court records filed in the multi-district litigation (MDL) case in West Virginia recently show that Johnson &Johnson continued to sell its vaginal mesh implant for nine months after the Food and Drug Administration (FDA) told it to halt sales. The agency told J&J to stop selling its product in August of 2007 so that the FDA could look into potential risk of organ perforation--what many women have experienced as a result of the implantation of the device.

The FDA said in a letter to J&J that it could not market its Gynecare Prolift device until it provided information about 16 "potential deficiencies." By failing to stop marketing the device, J&J was in violation of the Federal Food, Drug and Cosmetic Act.

This new discovery certainly lends strength to the hundreds of cases that have been filed against J&J around the country. Many of those cases have been consolidated in the MDL court under a single just in West Virginia.

J&J began selling Prolift in 2005 without filing a new application with the FDA, instead claiming that the device was substantially similar to other mesh on the market. The FDA, however, required J&J to go through the formal new application process. One of the most troubling recent revelations in mesh litigation is that all of the transvaginal mesh kits on the market were approved under this expedited FDA process and were based on a product that had been pulled from the market years before because of concerns over the product.

Events like these have caused congress to look into further legislating the FDA approval process for medical devices such as mesh. This, however, is little consolation for the thousands of women who have been surgically implanted with defective devices.

J&J has now announced that it will stop selling all four of its transvaginal mesh products. However, J&J denies that this is a "recall" of its products and claims that the devices were safe for the purpose for which they were marketed.

The FDA received many reports of complications from J&J's product from 2004 to 2007. The complaints include those of infection, abscess, and organ perforation. In my experience in these cases, many of these complaints have required additional surgery--anywhere from revisions to total hysterectomies.

If you believe you have had mesh implanted transvaginally because of urinary incontinence or pelvic organ prolapse, please call Corey Ann Finn at (502) 882-6000 or send her an email at corey@jonesward.com to discuss your potential case today.

We recently posted a blog regarding Ethicon's June 4th announcement that it was discontinuing sales of four of its transvaginal mesh systems. Ethicon is a subsidiary of Johnson & Johnson. The following products are no longer being sold:

• Gynecare Prolift Kit
• Gynecare Prolift + M Kit (more absorbable)
• Gynecare Prosima Kit
• Gynecare TVT Secur

You can read our recent post here. In the wake of this announcement, several significant facts have come to light regarding pelvic mesh implants.

The Medical Problem:

Transvaginal mesh products are predominantly intended for treatment of pelvic organ prolapse ("POP"), and stress urinary incontinence. POP occurs when a woman's pelvic organ, such as a bladder, drops from its normal spot and pushes against the woman's vagina. Prolapse derives from a Latin word literally meaning "to fall out of place." This can cause feelings of pelvic pressure, a pulling or stretching in the groin area or lower backache, painful intercourse, and stress urinary incontinence, among other things. It can be extremely uncomfortable and painful. It is more commonly seen in women as they age, women who have given birth to larger babies, or women who have had particularly long periods of labor.

The Products:

The Prolift and Prosima products--"POP Kits"--consist of a type of surgical mesh similar to woven fabric. They are marketed to OBGYNs and surgeons as a minimally invasive treatment for POP. A large part of the problem is that these products are marketed to doctors as having little or no complications--a fact that has since been found to be misleading. Doctors, in turn, pass this misleading claim to their patients, who are more likely to have the surgery because they believe the risks are low. Nearly 100,000 women each year are estimated to have these products surgically implanted. They are marketed as an alternative to other procedures that are seen as more surgically invasive.

The Gynecare TVT Secur, on the other hand, is a medical device known as a "mini-sling" to treat and prevent stress urinary incontinence (SUI). Similar devices have been around since the 90's. Because of this product's design, which only requires one intra-vaginal incision, as opposed to other procedures requiring multiple incisions, these products are also marketed as less invasive. Although Ethicon manufactures several types of sling devices, this is the only product subject to the sales halt.

The Product Problem:

As we reported earlier, transvaginal mesh implants have been linked to erosion of mesh through the vaginal walls, infection, bleeding, vaginal shortening and tightening, bowel, bladder and blood vessel perforation, discomfort and pain during sex and painful urination. It has also been linked to vaginal prolapse and stress urinary incontinence, which are the very medical issues it is designed to treat.

Complications with these implants, which are the subject of a large portion of lawsuits, include permanent injuries and disfigurement due to vaginal scarring and revision surgeries. Last year, the FDA reported that it found a fivefold increase in complications, severe injuries, and death associated with mesh implant products.

What's Happening:

Ethicon's recall of these four products is likely due to increasing scrutiny from investigators, including the Food & Drug Administration (FDA). Additionally, nearly 1,000 women who have had these or similar implants and have suffered serious pelvic injuries have filed lawsuits across the country. Last July the FDA released a public warning that there is a high incidence of reported adverse events associated with these products. The agency continues to investigate.

These products have also been criticized by the medical community and in scientific literature. According to these criticisms, there are several alternatives to these products that do not cause the severe adverse events and side effects linked to these products. Ethicon's recall of its products may be the first step in removing them completely from the market. And although the FDA has yet to step in, the agency's involvement is likely to increase based on the recall. Dangerous drug and medical device lawyers like those at JONES WARD PLC believe that Ethicon's recall implicates the dangerousness of its products. It has essentially pulled all of its synthetic mesh devices from the market. And this might only be the beginning: several other manufacturers of medical devices have similar transvaginal mesh products. They could be just as dangerous.

The good news? Recall of dangerous medical devices could save thousands of women from suffering significant and debilitating injuries. Increased FDA scrutiny and pressure from lawsuits signifies to these manufacturers that they should, and likely, will be held responsible for harming the public. But in the meantime, we will continue to update our blog with any news regarding these dangerous medical devices.

The defective drug and device lawyers at JONES WARD PLC are experienced in these types of cases. If you or a loved one has suffered an injury from a transvaginal mesh implant, or other medical device or dangerous drug, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.

Johnson & Johnson, a manufacturer of a variety of healthcare products, including medical devices, has recently announced that it asked the Food & Drug Administration's permission to halt sales of four transvaginal mesh implants. The following products are included in its request:

• TVT Secure
• Prosima Pelvic Floor Repair System
• Prolift Pelvic Floor Repair System
• Prolift MTM Pelvic Floor Repair System.

The sales are being halted in the wake of lawsuits filed by nearly 1,000 women who have had these or similar implants and have suffered serious pelvic injuries. An estimated 300,000 women have had the implants. The FDA is investigating as complaints of serious pelvic injuries and other adverse events continue to rise. Investigators are currently looking into other transvaginal mesh devices made by other manufacturers, including Boston Scientific and AMS.

And this is not the first time J&J has aroused concern. Johnson & Johnson's Ethicon unit began selling its first vaginal mesh product, Gynecare Prolift, in 2005. It is alleged to have sold the device for over three years before obtaining the proper FDA clearance. It was not until the company asked the FDA to market a related product that the agency became aware of its sales. J&J attempted to justify its action by arguing that a similar device was already on the market.

As early as last year, the FDA mandated that mesh manufacturers reclassify their devices as high-risk products, after discovering a fivefold increase in injuries, death, and severe complications related to the implants.

Transvaginal mesh is a type of surgical mesh similar to woven fabric. It is typically implanted to treat pelvic organ prolapse (when a pelvic organ, such as a bladder, drops from its normal spot and pushes against the woman's vagina) and stress urinary incontinence. These are usually implanted in women after childbirth.

Transvaginal mesh implants have been linked to erosion of mesh through the vaginal walls, infection, bleeding, vaginal shortening and tightening, bowel, bladder and blood vessel perforation, discomfort and pain during sex and painful urination. It has also been linked to vaginal prolapse and stress urinary incontinence, which are the very medical issues it is designed to treat.

Complications with these implants, which are the subject of a large portion of lawsuits, include permanent injuries and disfigurement due to vaginal scarring and revision surgeries.

We have blogged about this dangerous medical device three times. You can read our earlier blogs here, here and here. As more information comes to light, we will be sure to update you. The defective drug and device lawyers at JONES WARD PLC are experienced in these types of cases. If you or a loved one has suffered an injury from a transvaginal mesh implant, or other medical device or dangerous drug, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.662.8000 or layne@jonesward.com.

On January 4, 2012, the FDA announced that it is considering changing the classification of transvaginal mesh from a Class II to Class III medical device.

What is the difference between Class II and Class III?

A Class III device requires "an independent assessment of safety and effectiveness during a premarket review." Basically, a Class III drug goes through rigorous trials before it is approved by the FDA for use. A Class II device, on the other hand, may be exempt from this kind of testing or premarket review.

How did transvaginal mesh get approved by the FDA in the first place?

For most Class II devices, they are not required to go through premarket review because of the FDA's 510(k) submission process. This process allows drug companies to get their devices approved by the FDA by claiming that they are "substantially equivalent" to a device that has already been approved. 168 transvaginal mesh devices on the market became FDA approved through this process.

Was there any kind of testing of transvaginal mesh?

There were lab studies and animal studies that drug companies submitted to the FDA. There were no human studies.

If transvaginal mesh is reclassified from a Class II to Class III device, companies that make these devices will be required to go through postmarket surveillance studies. According to FDA policy, this process can take up to three years. It could have a very significant impact on some of the ongoing lawsuits brought by women and their spouses who have been injured by transvaginal mesh.

What is transvaginal mesh?

Transvaginal is mesh that is used in the vagina for certain surgeries to treat one of the following conditions:

• Pelvic Organ Prolapse (POP). For more information on POP, click http://www.the-recall-lawyers.com/2011/09/fda-to-hold-transvaginal-mesh.html#more
• Sudden Urinary Incontinence (SUI). This is a condition that occurs when a woman is unable to prevent urine from leaking from her urethra. There are many known causes, the most common of which is pregnancy. Multiple pregnancies may cause this condition to become permanent.

Continue reading "FDA Considers Requiring More Studies of Transvaginal Mesh" »

Following two days of meetings on transvaginal mesh, the FDA said it would require two makers of vaginal mesh, Johnson & Johnson and C.F. Bard Inc., to conduct clinical studies and present safety information on the use of mesh to treat Pelvic Organ Prolapse (POP).

The FDA had initially approved mesh under a summary proceeding requiring no preclinical testing. However, now at least seven deaths have been linked to its use. Problems caused by vaginal mesh have been described as extremely painful and include organ perforation, bleeding, and infection. Such complications may require corrective surgery.

Continue reading "FDA to Require Transvaginal Mesh Clinical Trials" »

The Food and Drug Administration plans to hold a subcommittee meeting to discuss "the safety and effectiveness of transvaginal surgical mesh for repair of pelvic organ prolapse" this week on September 8 and 9. This meeting comes at a time when consumer groups are calling for the widespread recall of surgical mesh due to severe complications.

Tranvaginal surgical mesh is used to treat Pelvic Organ Prolapse, a condition that occurs when the support in the vagina is lost which results in the dropping of the bladder, urethra and other pelvic organs. Vaginal mesh has also been used to treat Stress Urinary Incontinence, a condition that occurs due to weakening of the pelvic area muscles and causes short bouts of incontinence.

The FDA first warned of serious complications from transvaginal surgical mesh in October of 2008. It warned of erosion through vaginal epithelium--the wearing away of the thin lining covering the vaginal wall. Surgical mesh has also been linked to infection, pain, urinary problems, bowel, bladder or blood vessel perforations.

Continue reading "FDA to Hold Transvaginal Mesh Hearings This Week" »