Many companies, both American and worldwide, manufacture transvaginal mesh. It is typically made from synthetic materials, though animal tissue has been used as well.
One manufacturer of this mesh is Ethicon, Inc., a Johnson & Johnson subsidiary. Ethicon introduced their transvaginal devices to the market in March 2015. The company utilized a clearing method that allows new products that are predicated on existing and approved devices may forego the standard, rigorous approval process with the U.S. Food and Drug Administration (FDA).
In 2008, the FDA announced a Public Health Notification regarding patients and physicians reporting serious complications associated with mesh devices.
Purpose of Transvaginal Mesh
Transvaginal mesh is primarily used to repair pelvic organ prolapse (POP). Pelvic organs including the bladder, uterus, and bowel, are supported by several internal structures. When these support structures become too weak, stretched or broken, the pelvic organs drop from their normal position, and prolapse, or bulge, into the vagina. This is pelvic organ prolapse. While POP is not a life-threatening condition, it can significantly reduce quality of life with symptoms including disruption to sexual, urinary, and/or defecatory functions, and pelvic discomfort. Transvaginal mesh is surgically implanted in the vagina to strengthen the pelvic floor.
Transvaginal mesh can also be used to treat stress urinary incontinence (SUI). This refers to the unintentional loss of urine due to a physical movement that stresses the bladder, like coughing, sneezing, working out, laughing, or heavy lifting. In this scenario, the mesh can be implanted through the vagina to support the bladder neck or urethra.
Ethicon Abbrevo Transvaginal Mesh Safety Concerns
In October 2008, the FDA released a Public Health Notification regarding significant issues from the erosion and contraction of mesh, leading to surgeries and further complications. In July 2011, the agency further updated that notification to warn that these complications are not rare in patients who have been fitted with transvaginal mesh.
Mesh Erosion and Contraction Cause Severe Problems
The FDA began investigating reports of mesh complications as early as 2005, based on consumer and physician reports. The agency conducted a systematic review of research and published reports from 1996-2011.
The FDA has found that the most common and consistently report complication from transvaginal POP surgeries using mesh is the erosion of mesh. When the mesh erodes, it can require several surgeries to repair, and can debilitate patients. In some cases, the multiple surgeries aren’t able to resolve the complications.
Further, mesh shrinkage, or contraction, is another significant risk of transvaginal POP repair. As the mesh contracts, the vagina can shorten and/or tighten, and vaginal pain can be significant.
Both mesh erosion and mesh contraction can lead to severe pelvic pain, painful sexual intercourse, or a total inability to engage in sexual intercourse.
FDA Recommendations Against Transvaginal Mesh
The FDA strongly recommends against the use of transvaginal mesh, recognizing that most cases of POP can be successfully treated without the mesh. The agency further encourages public health providers to choose mesh placement surgery only after considering all other surgical and non-surgical options with the patient.
When option to use surgical, permanent mash, the FDA continues to make several recommendations to public health providers, including:
- Be aware of the risks associated with surgical mesh, and inform patients of the risks associated with the permanent implant and the serious complications and effect on quality of life post-surgery.
- Obtain specialized training for each mesh placement technique.
- Provide a patient, who has opted to use mesh in a POP surgery, the manufacturer information about the specific product used.
- Watch for complications associated with the mesh placement procedures.
Ethicon Abbrevo Transvaginal Mesh Lawsuits
Many lawsuits have been filed against Ethicon regarding the Abbrevo transvaginal mesh and associated pain and injury. Some have been settled with awards to the plaintiffs, but many lawsuits are ongoing.
There is a pending multidistrict litigation (MDL) against Ethicon. The U.S. District Court Southern District of West Virginia is overseeing MDL 2327.