The debate about the usage of surgical mesh products continues. Many, if not all, transvaginal mesh implants have been pulled from the market due to the FDA reclassifying transvaginal mesh products used to treat POP (Pelvic Organ Prolapse) into the highest-risk category. Therefore, transvaginal mesh surgery for pelvic organ prolapse POP repair has been deemed dangerous.
The FDA has now recalled all surgical mesh devices after discovering that women who have transvaginal mesh surgery with the device may have more negative effects than those who choose alternative surgical techniques. As a result, surgeons worldwide have returned to native tissue repair.
When was pelvic mesh first used?
Pelvic mesh is a medical device implanted through the vagina into women’s pelvic organs to address weaker pelvic floor muscles caused by pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
So when was pelvic mesh first used? Modern surgical mesh originated in the 1950s when surgeons utilized a mesh-like substance to treat hernias.
During the 1970s, surgeons used hernia mesh to treat pelvic organ prolapse and stress urinary incontinence. Initially, surgeons would fit and mold the mesh implant to each patient’s requirements before surgically implanting them into the abdomen to offer additional support to the pelvic muscles.
With the increased popularity of abdominal implantation for treating POP and SUI, medical device makers started attempting to build a mesh that could be used to treat pelvic floor disorders. According to FDA research, doctors preferred transvaginal implantation over abdominal surgery for pelvic floor disorder because it was considered less intrusive, faster, and gentler on the patient.
The first transvaginal mesh, known as the ProtoGen Sling, was created by Boston Scientific. Under a premarket program, the FDA authorized using the sling to treat SUI in 1996. But, three years later, the product was withdrawn due to emerging safety concerns.
Mesh, commonly known as slings or tape, was utilized for SUI surgery for the first time in 1998. This surgical mesh became widespread with the introduction of Tension-Free Vaginal Tape by Johnson & Johnson’s Ethicon business. It wasn’t until 2002 that a surgical mesh, particularly for women suffering from POP, was developed. Johnson & Johnson’s Ethicon division also manufactured Gynemesh PS.
The next innovation in transvaginal mesh occurred in the late 1990s when medical manufacturers started providing surgical mesh kits that included the pre-formed mesh device, female pelvic reconstructive surgery instruments, and surgical instructions for surgeons to follow.
Is mesh still used in prolapse surgery?
In 2011, the FDA issued a follow-up public health review of synthetic mesh, essentially redacting its previous report based on additional research and analysis. According to the FDA, serious adverse effects of the mesh are not uncommon. Transvaginally placed mesh to repair pelvic organ prolapse cases does not improve the outcomes of comparable non-mesh surgeries.
Later that year, the FDA met with the Medical Device Advisory Committee’s Obstetrics and Gynecology Devices Panel to discuss the safety and effectiveness of transvaginal mesh used in POP and SUI surgeries. Based on the panel’s discussion,
It was suggested that transvaginal mesh for POP be reclassified from a low- to moderate-risk device to a high-risk one. Transvaginal mesh used for SUI should be considered a low- to moderate-risk device.
The FDA continues to monitor the outcomes, safety, and efficacy of POP and SUI surgeries involving transvaginal mesh.
Is pelvic mesh the same as hernia mesh?
Hernia mesh and pelvic mesh have many similarities, including the same manufacturer in many circumstances.
Although vaginal mesh has been prohibited in numerous countries, several hernia meshes have also been pulled off the market due to safety concerns. For example, the Ethicon Physiomesh was recalled globally in 2016 after unpublished research revealed a greater risk of recurrence or revision surgery when compared to other comparable meshes.
How long does pelvic mesh last?
Mesh bladder slings made from plastic are the most frequent form of bladder sling used to treat stress incontinence. However, mesh slings have a more complication risk than tissue slings. Complications such as mesh exposure may develop during or after surgery.
Although long-term follow-up of some of the first women to get the slings revealed minimal issues after more than 17 years, the researchers caution that past research has connected the devices to chronic discomfort, pelvic pain, fistulas, and mesh erosions into the urethra or vagina.
Repeat surgeries to remove or replace the devices may be required to treat the mesh complications, which authorities in the United States have emphasized in consumer warnings and encouraged doctors to communicate to patients contemplating these treatments.
What are the symptoms of mesh erosion?
The Food and Drug Administration describes mesh erosion as a problem when mesh erodes through tissue and becomes exposed. The problem is also known as exposure, extrusion, or protrusion. According to the FDA, the most frequent mesh-related problem seen by patients undergoing transvaginal POP repair with mesh is vaginal mesh erosion.
Mesh protruding through the vaginal wall, debilitating pain, pelvic discomfort, and pain during intercourse are among the issues. Maintain your usual care if you’ve had this surgery.
When the mesh is used to treat stress urinary incontinence or prolapse repair, there is a tiny possibility that secondary complications may occur. The mesh may protrude through the surgical incision and into the vaginal canal.
The majority of patients with erosion have no symptoms. Many with symptoms report spotting, discharge, or partner discomfort during intercourse. Severe issues are uncommon.
By contacting a Chicago pelvic mesh attorney, you can have someone on your side fighting for you during this process, your health is most important.
Can pelvic mesh be removed?
The mesh implants are intended to be permanent, and they get lodged in the surrounding tissue within the first few weeks following surgery to give stronger pelvic support. If the implant becomes visible in the vagina, surgeons usually remove the mesh and sew it up, which may occasionally be done under local anesthesia.
But, if the patient has more permanent complications, such as discomfort, complete removal may take hours of surgery. Physicians must also consider the possibility of nerve damage and harm to neighboring organs, such as the bladder and intestine.
The degree and kind of mesh problem will dictate the nature of the revision surgery required. The removal of mesh normally requires a certain number of steps, the total number of which is dependent on the kind of mesh used. Women who have filed lawsuits against mesh producers say they’ve had to undergo multiple surgeries to remove the mesh.
Does the bladder mesh need to be replaced?
Women with a piece of mesh implanted transvaginally to address pelvic organ prolapse often have more severe, persistent, and difficult-to-treat problems than women with a mesh sling implanted.
Conservative erosion management may be achievable in certain instances. Some surgeons, for example, may prescribe topical estrogen cream to aid in healing vaginal tissues.
Nevertheless, women who developed recurring incontinence required removing the whole sling and installing a new sling.
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.