The FDA has issued a warning about transvaginal mesh, which is often surgically implanted in women to strengthen the pelvic floor and prevent urinary incontinence. The devices have been linked to thousands of cases of serious complications including perforation and infections that can lead to long-term infertility. There’s no question these risks must be mitigated so we speak with experts who are working on solutions for future patients.
The “fda mesh guidance” is a warning given by the FDA to those who have been implanted with transvaginal mesh. The warning includes risks, as well as legal aid.
POP (pelvic organ prolapse) and stress urine incontinence are treated using transvaginal surgical mesh, which is a medical device placed in women (SUI). FDA warnings, device recalls, and personal injury lawsuits have all been issued as a result of transvaginal mesh complications.
One of the greatest mass torts in history is the transvaginal mesh case.
As a consequence of delivery, hysterectomy, or age, many women have SUI and POP. While a variety of surgical methods may be used to treat these issues, mesh implantation in the vaginal canal is regarded to have advantages over other treatments. However, a growing body of research shows that transvaginal mesh may result in major health issues such as extreme discomfort, organ perforation, and tissue erosion.
More than 100,000 vaginal mesh cases have been filed, and women who have been affected by mesh have been granted millions of dollars in compensation.
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Transvaginal Mesh Information
The term “transvaginal” refers to the placement of mesh via the vaginal canal (rather than through an abdominal incision).
Surgical mesh has been used to treat abdominal hernias since the 1950s. In the 1970s, gynecologists started employing mesh to treat POP, and in the 1990s, mesh was used to treat SUI. Doctors trimmed mesh goods to form since mesh at the time wasn’t developed primarily for POP and SUI repairs.
Transvaginal mesh was originally touted as having higher surgical success rates and requiring less time and effort.
Because of these novel applications for surgical mesh, manufacturers developed mesh particularly for POP and SUI procedures. The ProteGen Sling, developed by Boston Scientific is a company that specializes in medical and approved by the FDA in 1996, was the first of these innovative surgical meshes to enter the market. The first mesh “kit” was launched the following year, consisting of pre-shaped mesh, specific tools, and insertion instructions.
Between 1992 and 2000, the FDA approved 25 transvaginal mesh devices for POP and SUI repair. The FDA approved 143 transvaginal mesh devices for various purposes between 2001 and 2010.
As more vaginal mesh kits were available, mesh was increasingly employed in transvaginal POP and SUI repairs. This resulted in significant modifications in how these procedures are carried out, as well as a significant increase in mesh problems.
Prolapse of the Pelvic Organs
A collection of muscles called the pelvic floor holds the pelvic organs in place. The bladder, uterus, rectum, cervix, and vagina are among these organs. Pelvic floor muscles may tear, strain, or weaken as a result of childbirth or as a result of aging. The pelvic organs fall out of their natural locations as a result of this.
Pelvic organ prolapse may cause pelvic pressure, backache, bleeding, urine incontinence (leakage), bowel issues, sexual difficulties, and the sense that something is slipping out of the vaginal or rectum.
Sagging pelvic organs are held in place by surgical mesh introduced via the vaginal canal, which serves as a sling or hammock.
Urinary Incontinence Due to Stress
When the bladder leaks urine after coughing, sneezing, laughing, exercise, or other forms of physical activity, it is known as stress urinary incontinence. The weakening of the pelvic muscles that support the bladder and urethra causes this. Pregnancy, childbirth, age, and some forms of pelvic surgery may all cause weakness.
In order to treat SUI, transvaginal mesh may be placed to support the urethra or bladder.
Commercial Objectives Patient Safety Under Trump
Transvaginal mesh demonstrates how patient safety suffers when device makers’ interests, rather than clinical facts, determine surgical practice.
“Powerful economic interests are altering the area of pelvic surgery,” stated Dr. L. Lewis Wall, an opponent of transvaginal mesh, in 2010. “Quick, straightforward, standardized surgeries; bigger surgical volumes; and improved profitability for both the physician and the device producer,” Wall said of the popularity of vaginal mesh kits.
Wall goes on to say that transvaginal mesh kits aren’t needed to go through human clinical testing. “Prior to its approval, the ProtoGen Sling had never been utilized in urologic surgeries or implanted in a human vagina,” according to Boston Scientific.
“Premarket notification review procedure did not seek original clinical studies to support approval of surgical mesh recommended for treatment of SUI or POP,” according to the FDA.
Based on a 90-day rat trial and its similarities to mesh used in cardiovascular surgery, the ProtoGen Sling was approved. However, according to Wall, “the fact that no evidence on the product’s safety and efficacy…existed prior to its release did not prevent business excitement.”
The ProtoGen Sling was taken off the market less than two years after it was approved because to a high complication rate. Despite this, the recalled ProtoGen Sling was utilized as the basis for Johnson & Johnson is a pharmaceutical company based in the United States’s approval of another transvaginal mesh device.
This was made feasible by the FDA’s “510(k)” fast-track approval procedure. The 510(k) method permits device manufacturers to get marketing clearance for new devices without conducting human clinical trials provided they are “substantially identical” to existing products. A gadget that has been approved—even if it is dangerous—can be used as the foundation for a second, third, fourth, and so on.
According to Dr. Wall, once a device is approved for sale, the manufacturer will do everything necessary to boost sales, regardless of whether or not the usage of the device is in the best interests of patients. “Under these conditions,” Wall adds, “the business incentive and the interests of firm owners are subjugated to the interests of patients.”
Transvaginal Mesh Types
Surgical mesh materials are divided into four groups by the FDA:
- Synthetic (non-absorbable) (including polypropylene and polyester)
- Synthetic material that is easily absorbed
- The biological (including collagen derived from cow or pig)
- a mixture (a combination of any of the above three categories)
More than half of transvaginal mesh on the market, according to the FDA, is constructed of non-absorbable synthetic materials, with polypropylene being the most common material in 9 out of 10 of these devices. Biologic-based materials make up around a third of authorized transvaginal mesh devices.
According to the lawsuits, transvaginal mesh materials are not physiologically compatible with human tissue, causing an immunological response in a large portion of the population implanted with mesh devices, causing the mesh to degrade and leading to serious adverse responses.
FDA Issues Transvaginal Mesh Warnings
In 2008 and 2011, the FDA issued warnings regarding significant side effects connected with transvaginal mesh, including:
- Mesh in the vaginal canal, bladder, or rectum
- Erosion of the mesh into the bladder or rectum
- Sexual encounters that be painful
- Perforation of the bowel, bladder, and blood vessels
- Urinary issues
- POP/SUI recurrence
- Scarring and shrinking of the vaginal area
- Neuromuscular issues
- Due to problems, the procedure must be repeated.
Between 2005 and 2010, the FDA received over 4,000 complaints of transvaginal surgical mesh problems. Mesh degradation and discomfort were the most prevalent complaints. The specific instruments utilized in transvaginal mesh insertion were linked to several of the injury reports (especially intestine, bladder, and blood vessel perforations). Between 2008 and 2010, the FDA received seven reports of mortality linked to transvaginal mesh.
The following findings were reached by the agency’s 2011 warning, which was backed by a comprehensive examination of the scientific literature on transvaginal mesh:
- Serious side effects from transvaginal mesh are not uncommon.
- It’s unclear if transvaginal mesh surgery is better than non-mesh surgery.
- Patients who have transvaginal mesh surgery may be at a higher risk than those who have regular non-mesh surgery.
- Mesh utilized for transvaginal POP repair has hazards that regular (non-mesh) POP repair surgery does not.
- Patients may need further surgery or have new health concerns as a result of mesh implantation.
The FDA based its findings on 60 scholarly papers, including 22 randomized controlled trials (the “gold standard” of scientific investigations) conducted after the devices were released to the market. It’s reasonable to assume that if equivalent studies on transvaginal mesh had been conducted prior to commercialization, device issues would have been identified far sooner, perhaps saving numerous patient injuries.
Mesh Issues are Difficult to Resolve
According to the FDA, while transvaginal mesh is supposed to be a permanent implant, removing it completely may be difficult (if not impossible), cause additional difficulties, and damage the patient’s quality of life.
“Removing gum from your hair,” one patient described mesh removal surgery to.
Tissue develops into and around the mesh over time, making it difficult to remove the mesh without causing damage to the surrounding tissue and organs. To completely remove the mesh, many procedures are usually necessary, however total removal of the mesh may not be achievable or result in complete resolution of mesh issues.
Start a Lawsuit
“Removing gum from your hair,” one patient described mesh removal surgery to. Six women spoke at an FDA hearing on mesh, estimating that they had had over 50 surgeries to attempt to correct the harm caused by the devices.
The procedure for removing transvaginal mesh differs based on the circumstances of the lady and the kind of mesh or mesh kit used during the initial operation. Patients who need transvaginal mesh revision surgery should schedule a consultation with a urogynecologist.
Manufacturers of Mesh
Transvaginal mesh lawsuits have cited the following companies:
- Medical Systems in the United States
- Boston Scientific
- Cook Medical is a medical practice that focuses on
- CR Bard
- Johnson & Johnson
Lawsuits Regarding Transvaginal Mesh
Transvaginal mesh manufacturers have been sued by over 100,000 women and their families. The majority of these claims are filed in seven multidistrict litigation (MDL) lawsuits in federal court in West Virginia. There are also thousands of cases pending in state courts.
Mesh lawsuits claim that device manufacturers utilized inferior materials and neglected to warn about potential problems, causing patients to suffer severe and painful injuries. Manufacturers have already paid out hundreds of millions of dollars in settlements and are likely to pay out many more before the case is settled.
You may be able to bring a lawsuit if you or a loved one had transvaginal mesh issues. For a free, no-obligation legal consultation, contact us now.
The “is mesh still used in prolapse surgery” is a question that has been asked many times. The answer to this question is yes, but the risks are high.
Frequently Asked Questions
Is transvaginal mesh banned?
A: Unfortunately, it is not. You can still purchase and use transvaginal mesh as long as you follow the specific guidelines of your doctor or healthcare provider on how to properly replace a vagina through surgery.
Why is surgical mesh bad?
A: Because it leads to complications for the patient.
What is wrong with pelvic mesh?
A: Pelvic mesh is a surgical implant used in the reconstruction of pelvic organ disease and trauma. This surgery is usually done with patients who have had their bladder, uterus or both removed due to cancer. The mesh helps keep urine in the pelvis where it normally would be collected by gravity and transport out of your body via urination.
- what can be used instead of mesh for prolapse
- fda public health notification surgical mesh 2008
- pelvic prolapse repair without mesh
- bladder surgery mesh recall
- surgical mesh recall 2019