Vaginal Mesh is a medical device which is implanted in the body to provide extra support in the condition of weakened repairing or damaged tissues. Generally, the material of mesh is composed of synthetic material or animal tissues. In case of synthetic mesh, the kitted or non-knitted sheets, made up of polypropylene- flexible and woven plastic. This plastic can be cut into different sizes and shapes according to the requirements of the procedure.
In the animal -derived mesh, the processed and disinfected intestinal or skin tissues are used for implantation. The animal tissues of porcine (pig) and bovine (cow) are mostly used in the formation of animal mesh. Based on its nature, there are two types of surgical mesh; absorbent and non-absorbent mesh. The former is permanent type of mesh which remains in the body while the later degrades in the body and lose its strength after some time. The absorbent mesh is used when longtime repairing or support is not desired.
What is Vaginal Mesh?
This net-like surgical mesh is used for Urogynecological surgeries (also known as vaginal mesh) like in the repairing procedures of Pelvic organ prolapse (POP) and stress Urinary incontinence (SUI). These two are common problems in women after the birth of baby and at the stage of menopause. Around 20% of women are suffered with these complications and the vaginal meshes are the treatment used for curing.
Generally, these are permanent surgical mesh procedures and commonly known as Vaginal mesh. The whole procedure is complicated and complex; starting from the designing of these mesh, implantation and to the post- surgical effects on the patients. The FDA has classified this surgical device as a “High Risk Device” but still some medical experts are using it.
What is a mesh implant used for?
Since early 1990s, the vaginal mesh is used in treatment of hernia within the abdomen when the organ protrudes through the patient’s abdominal muscles. The mesh is also used in the reconstruction of pelvic or vaginal walls in woman and for the stimulation of growth of impaired or damaged tissues of the body. The strength of the mesh is directly related to the supportive functioning of the mesh in the body after implantation; means the stronger device will support the tissues more powerfully. The key function of this surgical mesh is to support prolapsed organs. This support can be non-permanent or permanent. Globally, the vaginal mesh is used to treat:
- Pelvic Organ Prolapse (POP)
- Stress Urinary Incontinence (SUI)
Pelvic Organ Prolapse (POP)
Pelvic Organ Prolapse (POP) is a condition when muscles and ligaments supporting a pelvic organ of woman weaken and the pelvic organ slip out of place (prolapse). The most common treatment for this POP is the implantation of surgical mesh in the body of patient at a specific site which ultimately gives strength to reinforce the weakened vaginal wall. This mesh can be implanted in the body through two paths; the Transabdominal (through abdomen) or the Transvaginal (through Vagina).
Stress Urinary Incontinence (SUI)
In Stress Urinary Incontinence (SUI), the urine from the body is unintentionally discharged when the patient moves physically like during coughing, sneezing, running or lifting heavy things. Due to physical activity, the pressure develops on bladder and urine discharges. The surgical mesh is implanted in the body for the treatment of this condition. The implantation is done through vagina and ultimately mesh supports the urethra or bladder neck. This procedure is known as Mid-urethral sling or a mesh sling.
Is mesh safe?
Vaginal mesh can be a safe treatment if these meshes are used for the right candidates and by expert surgeons. But, no doubt, each type of mesh procedure has its own risks and benefits.
According to FDA, the organization has been reported about during surgery and post-surgery complications associated with the use of vaginal mesh in the women since 2011. Latest study proves that woman gives birth with first Uterus Transplant in United States. The reported complications include the adverse side-effects of mesh in the body and adhesion problems when the loops of intestine adhere with mesh or with each other. There are problems regarding injuries with nearby organs, nerves and blood vessels of patients. The surgery may include infection, bleeding, difficulty in intercourse, mesh erosion, chronic pain in lower pelvic and re-occurrence of hernia. FDA has recalled this vaginal mesh from the market and named as “high risk device” in 2016. FDA currently only allowing the use of vaginal mesh in treatment of POP with due complications but not for the SUI.
This action of FDA is endorsed by a recent death of 42 years old Chrissy Barjcic who suffered from urinary incontinence after delivering her second baby four years ago. The treatment was given with using vaginal mesh procedure in Ontario, Canada. The treatment is named as “Mid-urethral sling” in which the purpose of vaginal mesh was to support her bladder. Soon after operation, she suffered with severe pain which completely ceased her movements. Her medical advisors even removed the implanted vaginal mesh. But, unfortunate Chrissy Brajcic suffered with continued pain and infection reoccurred. Ultimately, she became resistant to antibiotics and suffered with sepsis in her last days of life. During her trouble days, she launched an awareness campaign for other ladies.
Complications can occur by any surgery but point of keen importance is that the surgeon must be expert in implantation of vaginal mesh and proper examination of patient and an appropriate candidate for the vaginal mesh implantation should be selected.
What are the symptoms of pelvic mesh complications?
Following are the indicators or symptoms of pelvic mesh like Prolapsed Uterus Symptoms after vagina mesh implantation surgery:
- Bloating / inability in passing stool
- Abnormal discharge
- Vaginal bleeding
- Increase in urine frequency
- Soreness and heat at the site of surgery
- Lumping at the site of surgery
- Fever, nausea and vomiting
- Pelvic pain and severe pain with intercourse
- Inflammation – with chronic wound- may lead to loss in stretch and deformity
In the medical science, none of surgery is free from complications. All the devices and products which are used during surgeries are passed after rigorous clinical trials and called sound safe and effective for the patients, but the complications are completely related to human limitations. These limitations include;
- Well-trained surgeons
- Health of patients/ patient health profile
Only the assumptions regarding trained surgeon and effective products by the patients are not going to work in the case of vaginal mesh procedures. There is a series of red flags in this procedure.
Can mesh cause cancer?
Researchers have recently revealed that the chronic inflammation after the implantation of vaginal mesh may lead to cancer. Undoubtedly, most of synthetic meshes available in market claim that vaginal meshes, their final products, are non-carcinogenic, but still inflammatory response of the patient’s body against an infected mesh may be a big reason of constant aggression of the patient’s skin. The patient can suffer with this chronic inflammation for years which may cause cancer. The only solution of this complication is to remove the infected vaginal mesh by the procedure of surgical excision.
Can a hernia be repaired without mesh?
Yes, the treatment which is known as “primary repair” goes without using mesh. In fact, a hernia is an abnormality in which there is a development of a hole in the fascia- a series of rigid connective tissues which keeps all other organs intact at a specific place in the body. Technically, if the nearby fascia to the hernia is strong and healthy than it can support the nearby organs intact- than the treatment can go without using mesh. However, medical researchers say that the treatment of hernia without using vaginal mesh can lead to re-occurrence of hernia. So, the medical surgeons prefer to implant vaginal mesh for the permanent solution of this abnormality. To control weight of patient follow our experts diet plan for diabetic patients.
The choice for treatment of hernia with or without mesh depends on various factors like body weight of the patient, previous history of surgeries, medical record of patient, conditions related to infection, the exact location of the hernia, situation and strength ratio of nearby tissues and many more. See these top 10 liver transplant centers in India also which are providing state of art services like mesh implants in USA.
Types of vaginal mesh implants
U.S. Food and Drug Administration have approved different types of vaginal mesh implants are as follows:
- Mini-sling implant
- Laparoscopic bladder suspension procedure
- Sacral Nerve Stimulation
- Bladder Muscle Injections
- TVT sling
- TOT sling
- Mini sling implant
There is another type of vaginal mesh implant used for the treatment of stress urinary incontinence. This procedure is latest and least invasive treatment. It takes five to ten minutes just like tension free tape min urethral slings. Mini sling procedure involves a single incision. This is latest and fast recovery process without damaging bowel, bladder and other major pelvic injuries due to its bypass retropubic needle passage altogether.
Laparoscopic bladder suspension procedure
This is another sling procedure used for severe stress urinary incontinence that is caused by incompetence of the internal `sphincter of the urethra. This condition involves open of the urethra due to incompetency of internal sphincter, after it small amount of urine retained in parts of urethra due to physical stress and cause leakage. Laparoscopic bladder suspension procedure is less invasive and open surgery. This device is a tube like with camera on its one end, then with small incision surgeons reach to the lower abdomen. A bright light directly shines in operative field with very sensitive camera; operative field can be seen very clearly. When it is opened the bladder neck is sutured to the pubic bone. This is very effective treatment with fewer side effects. Patients have reduced risk of surgeries, benefits of shorter hospital stays, and fast recovery.
Sacral Nerve Stimulation
This is another sling procedure that uses external device to stimulate the muscles of the bladder and pelvic floor. External device is tested for two weeks. This device is implanted beneath the skin. This therapy is used for the symptoms of overactive bladder. It works like reversible treatment in which small device send electrical impulses to the nerves that is located on the lower back. These nerves are called sacral nerves. Electrical stimulation helps in bladder control problem very easily. Before start this treatment you have to monitor bladder’s record for at least three days this baseline record may help in test stimulation.
In the very first stage the permanent lead implanted. In the operation theater you will lay face down on table and surgeon will give you anesthesia. Procedure involves insertion of needle and lead near the sacral nerve that is located in the lower back on the left or right side. In procedure doctor will ask you to identify the sensation like in vagina, rectum and parineal body. If pt feels the sensation then physician monitors the anus or toes. With all the confirmation of responses a lead wire that is threaded through the needle and remove the needle while leaving the temporary lead wire in place. The external device should be kept up to three weeks. During this procedure you will have to avoid from lifting, baths and sexual functioning.
In the step 2 the small pocket that is made during the first procedure is opened and made larger. Battery is placed in the pocket that is connected to the permanent lead that is arising from the sacral nerves. This procedure is done after general anesthesia. Doctor uses programmer to set stimulation settings for checking neurotransmitter information.pt have opportunity to turn on and off stimulator by hand to adjust battery output amplitude with the instruction of healthcare pt learn about operating programmer. Several visits may include for settings. Neurostimulator runs for 10 years but depends on the person’s usage. Neurostimulator can be replaced if battery runs out.
Bladder muscle injection
In the condition of full bladder with urine and patient feeling strong urge to urinate but she could not then in this condition doctors recommends bladder muscle injections that is called BOTOX injections. Botox injection is simply injected in muscle of bladder to relax. This treatment is very simple and easy not complicated but it takes 9 months for treatment. This treatment can use both male and female. To start the treatment firstly doctors do test to determine whether bladder is contracted or not. It is done to check the bladder is unable to store urine. If any damage occurs then doctors recommend medication to treat this problem or relax muscle. Drugs recommended known as anticholinergic Detrusitol, Vesicare and Lyrinel. Doctors recommend injection if medications do not work.
This treatment is based on one day procedure in which patient is admitted in hospital and instructed him/her to avoid drinking and eating before 5 hours. For this treatment anesthesia is given then cystoscopy performed and telescope is passed through natural way to bladder without incision. After examining bladder Botox is injected in bladder wall through needle and bladder emptied. Catheter can also be removed to empty bladder.
Tension free vaginal tape is used for remove stressful incontinence of urine, leakage of urine that can be due to coughing, sneezing, jumping, lifting, exercising or other activities. If bladder muscle lost support and strength, In this case urethra no longer closed when extra pressure is put o the bladder. This treatment requires small incision in it. 1 cm cut is made on the lower abdomen with 3-cm incision in the vagina to insert the tape in place. It takes one night stay at hospital.
TOT sling is known as transobturator tape sling this is also used for the incontinence of urine. It is like TVT very effective treatment.
Vaginal mesh lawsuit
In class action over vaginal mesh lawsuit is under trial due to the flaws in company’s mesh products. But on the other hand medical specialist fined that implants are still beneficial.
Johnsons & Johnson settlement
Johnson & Johnson pharmaceutical company is settling the vaginal mesh implant lawsuit in Australia due to flaws in mesh products. At least 700 women are facing these issues including pain, and other complication Johnson& Johnson have faced aggressive promotion designed to persuade surgeons and patients for operation unable to resolve difficulties in this case Tony Bannon told the court in his opening submissions.
Lawsuits have filed against Johnson and other manufacturer in united state and the United Kingdom. In this case one woman in United States awarded $57 million over damages against Johnson & Johnson mesh products. J&j agreed to pay $120 million to settle 2,000 -3,000 mesh lawsuits in January 2016.
Boston scientific manufacturer have faced a lot of issues related to mesh implant. They have approximately settled 20,000 mesh lawsuits.