What are transvaginal mesh implants?
Transvaginal mesh implants were first used as standard therapy to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse repair, which are frequent problems after delivery. However, these medical procedures have resulted in life-altering problems for many women, including nerve damage, pelvic pain, and pelvic floor disorders.
Transvaginal mesh products exist in various shapes and sizes, including tape, ribbon, mesh, sling, and hammock. Transvaginal mesh implants are classified into four types:
Absorbable synthetic – This synthetic mesh dissolves over time as the body absorbs it. It promotes tissue development at the surgery site, assisting the body in strengthening pelvic ligaments.
Nonabsorbable synthetic materials – This plastic or polyester implant is meant to be permanent. Polypropylene, a form of plastic, accounts for about 90% of nonabsorbable synthetic mesh. This category contains more than half of all FDA-approved mesh implants. This is the most common implant since it is said to respond better with connective tissue and help the body mend itself. These are also regarded as having the lowest infection rate. However, a major plastics specialist has raised concerns about using polypropylene in the human body.
Biological – These are the “natural products” made from sterilized animal tissue that dissolve and absorb into the body over time.
Composite – These are constructed from a blend of absorbable synthetic, nonabsorbable synthetic, and biological mesh.
When was the surgical mesh introduced in the US?
The first mesh implant for SUI, Boston Scientific’s ProteGen Sling, was approved by the US Food and Drug Administration (FDA) in 1996. The first POP mesh device was authorized in 2002.
Boston Scientific withdrew the ProteGen Sling in 1999 due to patient difficulties, but not before numerous similar mesh implants were authorized under the FDA’s 501(k) procedure because they replicated the ProteGen Sling’s design. The 501(k) is a premarket application to the FDA that shows the device is substantially identical to another legally marketed product.
Following these first introductions, more and more mesh items were created and released into the market across the world.
Complications related to transvaginal mesh surgery that led to the lawsuits
While short-term clinical research demonstrated that the most popular mesh products had a success rate to treat pelvic floor disorders and a low incidence of problems for SUI, longer-term trials show that mesh implants for POP have a greater rate of complication. There is also insufficient evidence to support the products’ long-term usage. According to NHS data, one in every 15 women with the most common mesh implants will require transvaginal mesh removal surgery.
The following concerns were raised in complaints:
- Mesh erosion
- Nerve damage
- Neuro-muscular issues
- Pelvic organs perforation
- Debilitating pain
- Painful intercourse
- Stress incontinence
- Vaginal scarring
- Vaginal shrinkage (as scar tissue builds)
Patients who develop mesh erosion or organ perforation will almost certainly require multiple procedures to correct the problem. Because mesh implants were intended to remain in the body and perhaps foster tissue growth of weakened or damaged tissue, removing them is a painful experience and may need multiple surgeries, as blood vessels and tissue keep the mesh firmly in place. This implies that surgeons must remove one component (and one reconstructive surgery) at a time.
Bans and limitations on mesh products
In November 2017, The Therapeutic Goods Administration of Australia determined that the risks to patients of employing mesh to treat POP exceeded the benefits and discreetly prohibited using the devices for this surgery.
In April 2019, FDA ordered manufacturers of surgical mesh devices for transvaginal repair of pelvic organ prolapse to cease marketing and distributing their goods immediately. As a result, there are presently no FDA-approved surgical mesh solutions for transvaginal POP repair that may be lawfully implanted in the United States.
The Ministry of Health in New Zealand followed suit and prohibited using any pelvic mesh. It remains the only country that does so for both Pelvic Organ Prolapse and Stress Urinary Incontinence.
In July 2018, the UK Department of Health and NHS England acknowledged Baroness Cumberlege’s suggestions that mesh implants could not be declared safe unless specific requirements were satisfied. The requirements were that doctors only undertake the procedures if they were adequately educated and did them regularly and that a register on the devices be created to track mesh complications as they arise.
The British National Institute of Health and Care Excellence (NICE) decided in April 2019 that mesh implants might be distributed by NHS in England again if they followed Cumberlege’s criteria. However, the NHS is not required to follow NICE’s recommendations, and the ‘hold’ on these procedures remains in place.
The medical profession took this stance because far too many women were encountering mesh-related complications.
Do you have a transvaginal mesh lawsuit?
If you have any of the following symptoms, you may be eligible to join an active case:
- Infection: According to research, bacteria might develop on the medical device, resulting in infection.
- Surgical mesh erosion occurs when the mesh causes harm to the weakened vaginal wall or other internal pelvic organs.
- Mesh can induce pain by cutting into tissues, shrinking, damaging nerves, and causing scar tissue to form. As a result, unpleasant movement or even painful sex may occur.
- Recurring incontinence: This is a new symptom that can occur after obtaining an implant; if the patient had mesh expressly for stress urinary incontinence, it could worsen the condition.
- Recurring pelvic floor disorder: The mesh implant may fail to treat pelvic organ prolapse, causing the condition to reoccur.
- Urinary problems: Surgical mesh can cause serious complications, bladder blockage, making urinating difficult or uncomfortable.
Transvaginal mesh lawsuits
Most surgical mesh lawsuits are product liability actions that rely on the legal idea of faulty items. The active transvaginal mesh cases are a set of product liability claims. Therefore, if you wish to join a case, you must do so if you have transvaginal mesh surgery complications.
When pursuing a product liability lawsuit, the court often applies either the idea of negligence or strict responsibility, with the latter implying that the defendant’s intent was irrelevant as long as the product was faulty.
A transvaginal mesh product that did not work as it was supposed my fall into these categories in the lawsuit: failure to warn, manufacturing defects, or design defects.
Transvaginal mesh product liability litigation settlements might take a long time. Many issues must be answered, such as which firms manufactured the mesh, where problems occurred in the supply chain, who implanted it, and what health concerns the device created. This will lead to a great deal of discovery between the parties.
However, if you or a loved one has had complications with transvaginal mesh, please get in touch with Thomas Plouff for a free consultation about what can be done for you.