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 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.
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 firstname.lastname@example.org.