Transabdominal Mesh Complications
The FDA has prohibited the sale of most surgical mesh devices for transvaginal pelvic organ prolapse (POP) treatment.
The FDA’s decision has left some women anxious and confused, mainly because there are various forms of surgical mesh surgery used to treat pelvic floor disorders, and the FDA decision only impacts one approach—transvaginal mesh surgery. An incision in the vaginal wall is made, and mesh is inserted to support the prolapsed pelvic organs. (The idea is for a woman’s tissue to grow into the mesh openings, forming a supporting wall.)
The Food and Drug Administration said the device makers had not established a reasonable assurance of their safety or efficacy by the FDA deadline. Complications documented in lawsuits against the TVM manufacturers include bleeding, erosion, discomfort, inflammation, and infections, which have led to roughly $8 billion in payouts to 100,000 women.
Notably, the FDA imposed no limits on using mesh during prolapse surgery through the abdomen (transabdominal). It also does not affect the transvaginal use of pelvic mesh to treat SUI, often known as mesh sling treatment.
Why was surgical mesh used in transvaginal and transabdominal issues?
Since the 50s, polypropylene mesh was used to treat abdominal hernias. Historically, pelvic organ prolapse using native tissue repair or sutures that attach the prolapsed organ to a nearby muscle. Although this is still feasible for most women, some do not have enough or strong enough native tissue. This strategy is not always successful and doesn’t treat pelvic floor disorder.
As a result, gynecologists and urologic surgeons started trying transvaginal mesh implants in the 70s, cutting them themselves and inserting them via abdominal incisions. In the 1990s, a minimally invasive transvaginal mesh implant surgery was developed, which included creating an incision in the vagina to implant the pelvic mesh to reduce recovery time.
Meanwhile, the FDA sanctioned the first surgical mesh considerations for stress incontinence (the mid-urethral sling) in 1996. The first mesh for transvaginal pelvic organ prolapse repair was authorized in 2002. Manufacturers started producing kits, including surgical instruments and mesh for female pelvic reconstructive surgery during this period, with the first receiving FDA approval in 2002.
Do they still use mesh for uterine prolapse?
The FDA has restricted the sale or distribution of surgical mesh devices for transvaginal correction of pelvic organ prolapse.
The following are two frequent pelvic floor operations that employ mesh and are not impacted by the FDA announcement:
Transabdominal mesh to treat pelvic organ prolapse: This minimally invasive surgery involves introducing the mesh to support organs via a tiny incision in the abdomen or laparoscopically (small incisions around the pelvic muscles navel and using a camera). This technique has been around for over 30 years, thoroughly researched, and proven safe.
Procedure for using a mid-urethral sling: This is the most often utilized procedure to treat stress urinary incontinence. Your surgeon will make three smaller incisions (one in your vagina and two above your pubic bone) and inserts a thin strip of synthetic mesh under your urethra to raise and support it and the bladder neck. It’s a safe and less complicated surgery you can have for urinary and stress incontinence.
Using mesh in vaginal surgery to address uterine prolapse is no longer an option. If you have this problem, you should not have mesh put in via a vaginal cut. The mesh may increase your chances of mesh-related complications after surgery.
What are the side effects of the bladder mesh?
Between 2008 and 2010, the FDA received multiple reports of problems associated with using surgical mesh devices for POP repair, with many needing further intervention, including surgical treatment of transvaginal mesh removal and hospitalization. The following were the most common complications:
- · Vaginal mesh erosion/protrusion via the vagina
- · Extreme pelvic pain
- · Bleeding
- · Infection
- · Dyspareunia (painful sexual intercourse)
- · Perforation of organs caused by surgical equipment used in the mesh implantation technique
- · Urinary issues
- · Prolapse reoccurrences
- · Neuromuscular issues
- · Weakened vaginal wall
- · Emotional issues
- · Mesh contraction results in vaginal shortening, tightness, and discomfort.
Is mesh used in abdominal hysterectomy?
A hysterectomy is one of the most frequent surgical operations done on women throughout their reproductive years, and it entails the removal of the uterus as well as the cervix, ovaries, and fallopian tubes.
The mesh was also used to prevent recurring vagina bleeding during a hysterectomy. Often it happens when the vaginal surface changes shape and drops into a downward vein.
Why did FDA ban surgical mesh intended for transvaginal use?
Transvaginal mesh was initially used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in the mid-90s. It is implanted transvaginally or via the vagina for pelvic organ prolapse repairs or bladder suspension operations.
Transvaginal mesh was first authorized based on similarities to other mesh devices already in use, using a procedure known as the FDA 201(k), which permits medical device manufacturers to “skip” expensive clinical studies. Many transvaginal mesh devices were never tested on people before they were approved.
The FDA’s 501(k) procedure may be partially to blame. A statement issued in 2008 stated transvaginal mesh products did not seem to be more effective or safer than current surgical therapies for POP or SUI, and that the implants may raise the risk of serious side effects.
The transvaginal mesh was withdrawn from the market and is no longer accessible for new surgical insertion. Though items were not forced to be returned, all transvaginal placement manufacturers were told to stop producing them, and the transvaginal mesh was classed as a higher-risk medical device.
Transvaginal mesh is no longer used in operations after the declaration, yet many women continue to experience difficulties due to the existing mesh. More than 100,000 lawsuits have been brought against transvaginal mesh manufacturers due to injuries.
Why are mesh manufacturers Ethicon, Boston Scientific & Coloplast in the hot seat?
Transvaginal mesh injuries have resulted in several lawsuits. Many of these cases have been resolved, while others may still be pending in federal, state, and municipal courts.
Ethicon or Johnson & Johnson, Coloplast, and Boston Scientific are among the companies implicated in transvaginal mesh cases.
Most transvaginal mesh claims were resolved after numerous bellwether judgments yielded millions of dollars in compensation to wounded plaintiffs.