The transvaginal mesh implant is one example of a medical product with recognized negative side effects. Many victims have claimed they were not adequately informed about the potential complications associated with transvaginal mesh products. Some surgeons have been accused of performing unnecessary procedures without considering less harmful or invasive treatments, calling into question the safety of these implants.
Transvaginal Mesh: What Women Should Know
This transvaginal mesh implant was developed to treat stress urinary incontinence and repair pelvic organ prolapse, a common issue for women following hysterectomy, menopause, and vaginal delivery. When a woman’s pelvic muscles become too weak, pelvic organs, including the uterus, rectum, and bladder, may prolapse into the vagina.
While the transvaginal mesh technique was developed to treat pelvic floor disorders, not all surgery versions are risk-free and dependable. Several of the vaginal mesh products had severe side effects, including infection, erosion of vaginal tissues, and organ perforation.
Transvaginal mesh surgery has a greater complication risk than older therapies for pelvic organ prolapse and stress urinary incontinence while being less intrusive and easier to recover from.
It was reported in 2011 that the FDA had received 4,000 complaints of problems from transvaginal and pelvic mesh products in the preceding six years. Almost 23,000 lawsuits were brought by women hurt by mesh products when they had difficulties after having mesh implants, and manufacturers have paid over a million in punitive damages.
By contacting a Chicago transvaginal mesh attorney, you can have someone on your side fighting for you for these issues.
FDA ban on transvaginal mesh: What does it mean for women facing pelvic organ prolapse?
When the Food and Drug Administration (FDA) prohibited the sale of all transvaginal mesh devices for pelvic organ prolapse repair in April 2019, it sparked a frenzy of misinformation about an often misunderstood condition.
Living with POP may be embarrassing. A sense of pressure or a bulge coming out of the vagina, difficulty urinating, incontinence, or pelvic pain even during sex are all symptoms. Many women suffer in silence for many years before seeking treatment.
Several women who chose transvaginal mesh surgery to solve their condition had consequences such as bleeding, pelvic discomfort, pain during intercourse, and vaginal wall erosion.
The FDA verdict in 2019 ended a treatment that did not always result in safe and favorable results. In a 36-month postmarket surveillance study, the FDA found that the benefits of using surgical mesh to treat POP transvaginally do not exceed the risks.
Transvaginal mesh patients should continue with their annual and other regular check-ups and follow-up treatments. The FDA recommends if the patient is happy with the results of their operation and shows no signs of problems or discomfort, further treatment is unnecessary.
Persistent vaginal bleeding or discharge, pelvic or groin discomfort, or pain during sexual intercourse are all symptoms that patients should report to their doctors. Women who are thinking about having a surgical mesh surgery should talk to their physicians about their choices first.
Using Transvaginal Mesh for Incontinence or Prolapse
Doctors use surgical mesh devices to treat pelvic organ prolapse or stress urinary incontinence. Those who are symptomatic have pain, discomfort, or other unpleasant symptoms.
Some people are asymptomatic and may not recommend surgery, while others may benefit from conservative measures.
Physicians may offer mesh surgery when non-surgical options such as exercise, pelvic floor therapy like kegel exercises, or pessaries fail.
Mesh Types, Manufacturers, and Brands
The FDA classifies pelvic mesh used in gynecology into four groups depending on how the vaginal mesh product behaves after implantation.
Synthetic materials like plastic or polyester are used to create non-absorbent synthetic meshes. Polypropylene is the standard material for mesh implants.
Tissue develops at the implant site when the body breaks down the absorbable synthetic mesh. The pelvic ligaments benefit from this as well.
The term “biologic mesh” refers to devices made from sterilized animal tissue. Often crafted from bovine (cow) or porcine (pig) tissue, these surgical meshes deteriorate with time.
Non-absorbable synthetic mesh combines biological or re-engineered natural tissue to create a composite mesh.
Examples of brands that create meshes are:
Ethicon/Johnson & Johnson
· Gynecare TVT Secur
· Gynecare Prolift Kit
· Gynecare Prosima Pelvic Floor Repair System
· Gynecare Prolift + M Kit
· Aris Transobturator Sling
· Novasilk Slinge
· Avaulta Plus
· Avaulta Solo
· Pelvilace Support Systems
· Align Urethral Support System
· Uretex Urethral Support Systems
Boston Scientific Corp
· Uphold Vaginal Support System
· Pinnacle Pelvic Floor Repair Kit
· Obtryx Slings
American Medical Systems
· MiniArc Slings
· Bio Arc Slings
· Monarc Slings
- Ob Tape
Complications and Revision Surgery
Women who have had a transvaginal placement to treat pelvic organ prolapse are more likely to develop severe, persistent, and difficult-to-treat problems than those who have had a mesh sling inserted.
The incidence of bladder perforation and pelvic bleeding, as well as postoperative urinary incontinence and discomfort during intercourse, were all higher in women who had a transvaginal mesh implant.
The FDA advises that the most common consequences are erosion of the vaginal epithelium, infection, discomfort, urinary difficulties, and a recurrence of prolapse or incontinence. Several cases of perforation of the colon, bladder, and blood vessels after insertion have also been reported. Vaginal scarring and mesh erosion have been linked to severe reductions in patient quality of life owing to pain and discomfort.
These issues may also lead to further difficulties, such as serious complications, and you may require multiple surgeries and intravenous (IV) therapy, blood transfusions, or the treatment of hematomas or abscesses.
Transvaginal Mesh Lawsuits & Transvaginal Mesh Lawsuit Update
To date, more than 55,000 women have brought transvaginal mesh lawsuits against the manufacturers of these transvaginal mesh implants and products. Since the mid-1990s, as many as 500,000 transvaginal mesh implantations have been done annually. Thousands upon thousands of other women are likely to have significant transvaginal mesh complications as a direct consequence of these surgeries due to a large number of reported injuries.
Pretrial proceedings for many other transvaginal mesh device cases began converging in West Virginia federal court before Judge Joseph R. Goodwin in 2010. Throughout April 2014, the Southern District of West Virginia was home to seven MDLs.
State courts also hear several remaining mesh lawsuits involving these mesh manufacturers. Furthermore, Caldera Medical is being sued for its mesh devices, but the action is not being handled as an MDL in federal court in West Virginia.
If you or someone you know is suffering from pelvic prolapse pain due to transvaginal mesh, don’t hesitate to get in touch with a product liability lawyer and the Law Offices of Tom Plouff Chicago for a free consultation.