Lately, pelvic mesh injuries have been a hot topic in the media, but what are they? What causes them, and how can you prevent getting one? What can you do if you suffer from pelvic mesh injuries? The National Institute of Health (NIH) defines pelvic mesh injuries as “a complication that occurs during the surgical placement of a device called transvaginal pelvic mesh.” This device treats pelvic organ prolapse and stress urinary incontinence in women and stress urinary incontinence in men.
Pelvic mesh injuries occur due to some defect in the mesh itself or the surgical placement of the mesh. This article will serve as a guide to the potential dangers of pelvic mesh surgeries and the legal options available to you if you or someone close to you has suffered harm as a result of one of these surgeries.
What’s a pelvic mesh?
Pelvic Mesh is a manufactured, sold, and implanted medical device to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It’s intended to be permanent, and one problem is that it is dangerous to remove the mesh, and often the entire mesh is incapable of being safely removed, when the woman suffers complications from the mesh, like erosions, pelvic pain, and pain with sex. Although polypropylene was originally developed for for hernia repair, it then started to be used in the woman’s pelvic area.
Here are anatomical drawings showing where transabdominal mesh is placed:
The FDA requires that these devices provide long-term effectiveness, be effective after only one implantation, and cause no long-term damage. The devices are made of a synthetic polypropylene polymer and are designed to fuse with surrounding tissue over time.
Note: A number of federal agencies, including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the American Urogynecologic Society, and Consumer Product Safety Commission (CPSC), have conducted studies on these devices. The studies have confirmed that transvaginal mesh is often not properly tested before being released. Specifically, it was found that these devices were not tested for safety or efficacy before being released on the market. Other federal government websites have also revealed that doctors were not always provided with full information about these devices before surgery.
What is a pelvic organ prolapse?
Pelvic organ prolapse (POP) is a condition affecting the pelvic organs. Commonly it refers to the descent of the uterus, bladder, and urethra into the vagina. The latest health news indicates that close to 9 million women in the U.S. suffer from some type of pelvic floor disorder, which can include uterine prolapse, bladder prolapse, and pelvic organ prolapse. Pelvic organ prolapse can range from mild to severe, and symptoms may include vaginal bulging that’s noticeable or a feeling of pressure, discomfort, heaviness, or a sense of “something falling out.”
Some women with pelvic organ prolapse can manage their POPsymptoms with conservative measures, like a pessary. But many women want a “fix” that a pessary does not provide. . For others, surgery may be necessary to support the pelvic organs. Surgery may also be necessary if other symptoms related to vaginal pressure or pain are severe enough to disrupt daily activities or quality of life, for example, if there’s discomfort with sexual function or during bowel movements.
What causes pelvic organ prolapse?
Pelvic organ prolapse is also known as pelvic floor disorder, is caused by weakening the muscles and support tissue in and around the pelvis. This weakening can be due to childbirth, chronic infections, constant straining, or age. The severity of a woman’s pelvic organ prolapse depends on the weakness in the pelvic support structure. The chief cause of pelvic organ prolapse is childbirth. Pelvic mesh implants can cause pelvic mesh injuries. Hernia mesh injuries can be caused by hernia mesh and hernia mesh complications. Pelvic floor disorder can also occur in women who have undergone a hysterectomy or have been treated for endometriosis.
Pelvic Organ Prolapse: Symptoms and Treatment
Pelvic organ prolapse occurs when a pelvic organ descends into or out of its normal anatomical location. This occurs most commonly in women who have given birth or the following menopause when estrogen levels decrease. Some types of surgery may be performed during vaginal childbirth, including a cesarean section, episiotomy, or repair of tears. Other pelvic organ prolapse symptoms include:
- The feeling that you can’t empty your bladder as well as you used to due to pelvic organ prolapse
- Tissue protruding from the vagina
- Bowel problems
- Weight loss due to severe pelvic organ prolapse
- Pain with sex
- Pelvic pain (painful urination and pelvic cramping)
The symptoms of pelvic organ prolapse typically start slowly and worsen over time. By the time you notice the symptoms, the condition may have been present for several years. If left untreated, pelvic organ prolapse can lead to several serious health problems, including urinary tract infections and chronic constipation.
If you have symptoms of pelvic floor disorders, speak with your doctor right away to discuss a treatment plan. For example, you may be prescribed pelvic floor muscle strengthening exercises or vaginal pessary devices to help stabilize the weak muscles and organs.
How is pelvic organ prolapse diagnosed?
To determine if you have pelvic organ prolapse, you’ll likely need a physical examination, which is sometimes done by a doctor specializing in pelvic floor disorders (urogynecologist). An evaluation for pelvic organ prolapse begins with a medical history, physical exam, and diagnostic test. In addition, the following may be checked.
- A bulge in your vagina or vaginal area
- Pain in your pelvic area – this is a sign of a serious pelvic organ prolapse
- Urinary urgency, frequency, and leakage
- Bowel urgency and changes in bowel habits
- A prolapse of your bladder, rectum, uterus, or small bowel into your vagina
According to Harvard medical school, most doctors will perform a pelvic examination to look for the physical signs of uterine prolapse. You may need to lie on your back and raise one leg, then the other. Your doctor will insert a finger or two into your vagina and gently feel your pelvis. Next, your clinician will press down on your abdomen (tummy) to feel whether any organs are protruding.
Surgery for vaginal vault prolapse?
The four most common types of uterine prolapse/ pelvic organ prolapse surgeries are:
Uterine prolapse/Vaginal surgery
Also called vaginoplasty, it is a procedure that reconstructs and supports the vagina (to prevent pelvic organ prolapse), including the removal of excess tissue. The word “vagina” comes from the Latin “vagina,” which means sheath or scabbard.
The vagina is the passageway between the cervix and the vulva. It extends into the body to form a hollow organ that surrounds the opening of the cervix and leads to the uterus. Its outermost layer of tissue can be seen as a thin strip along the inner lips, while a deeper muscle layer extends along the length of the passageway.
Pelvic floor disorders occur when one or more of your pelvic organs (the small intestine, bladder, urethra, etc.) have slipped out of place and are no longer held by surrounding muscles and ligaments. The vagina changes in size during sexual arousal; it will increase slightly in length and width. This causes an increase in blood flow to that area which can be felt as vaginal lubrication.
This reconstructive surgery involves repositioning the vagina and supporting it with special mesh material or stitches attached to your body. Vaginoplasty procedures can be performed as minimally invasive surgeries using local anesthesia. The goal of this type of pelvic organ prolapse surgery is to:
- Repair a vaginal defect
- Improve urinary control
- Prevent a recurrence of prolapse
- Some risks of vaginal repair include: bleeding, infection, scar tissue
Recurrence of prolapse – Pelvic organ prolapse is when your organs fall out of place again after the pelvic organ prolapse surgery. If you have a recurrence, you may need another reconstructive surgery or expert opinion.
Hysterectomy: obliterative surgery.
If you have severe prolapse and want to avoid further pelvic organ problems, your doctor may recommend a hysterectomy. Pelvic organ prolapse treated with this kind of surgery removes your uterus and cervix, weakening pelvic floor muscles even more if the surgery is not handled properly.
Cystocele and Urethrocele Repair:
These two conditions occur when the bladder and urethra drop into the vaginal canal. A cystocele repair surgery, called a cystocele repair, corrects the condition by tightening and strengthening the supporting connective tissues in the vaginal wall.
A urethrocele repair aims to cure urinary leakage by lifting and supporting the urethra in the vaginal canal. Both surgeries are performed under general anesthesia, and patients often return home on the same day.
Although cystocele and urethrocele repairs are the least invasive surgeries, they pose risks. This vaginal vault organ prolapse surgery is especially risky for women with certain pre-existing medical conditions or a history of pregnancy complications. In addition, if you have a weakened pelvic floor or vaginal wall, which is often a result of childbirth or aging, you may be more prone to health complications from these types of surgeries. Risk factors that may increase the chance of complications during and after this surgery include:
- Pregnancy complications:
- Vaginal vault prolapse surgery is not recommended for women who have had multiple vaginal births (multiple vaginal births increase the risk of severe pelvic organ prolapse) or women who have had a C-section to deliver a child (a C-section is the major operation that delivers a baby through the abdominal and uterine walls, rather than through the vagina)
Rectocele Repair Surgery/Sacrocolpopexy:
If you have a rectocele or rectal prolapse, your doctor may recommend a rectopexy. Treating pelvic organ prolapse through this reconstructive surgery entails using staples to tighten weakened tissue and bring the vaginal vault closer together to repair pelvic floor disorders. It can also reduce lower back pain in women with a prolapsed uterus or bladder. In some cases, it can be performed simultaneously as other pelvic floor surgeries.
Important: While surgery might be an effective solution, many women with pelvic organ prolapse and urinary incontinence do not choose surgery. Instead, they use pessaries as pelvic organ prolapse treatment until surgery is needed or when medical conditions worsen.
Pessaries are also used as a stopgap measure for tissues support before surgery. Pessaries are small devices inserted into the vagina to support the vaginal walls and bladder. The doctor will insert the pessary into the vagina to help restore the organs to their proper position.
A pessary (removable device) can make life easier for a person with pelvic organ prolapse and urinary incontinence, but it does have some downsides. For example, you must check your pessary regularly to see if it needs replacing or adjusting. If it does, you’ll need to make a trip to see your doctor. Removing a pessary can also cause discomfort or even injury if it doesn’t come out correctly.
Pessaries aren’t for everyone because they don’t treat the underlying problem with pelvic organ prolapse. However, they can help buy you more time before surgery while your symptoms improve. And they can allow you to keep active until your symptoms worsen enough to necessitate further treatment.
Barring surgery, here are some tips to prevent pelvic floor disorders:
- Change your diet to achieve a healthy weight.
- Physical therapy for both pelvic organ prolapse and pelvic floor muscle training
- Kegel exercises. Kegel exercises, also called pelvic floor exercises are one of the most effective ways to strengthen and combat pelvic organ prolapse, or pelvic floor disorders.
For proper Kegel exercise:
- Find a comfortable position on the ground. You can sit cross-legged or lie down on the floor.
- Contract your muscles to stop the flow of urine from your vaginal vault. Then release to relax for a few seconds. Try this several times until you get used to the sensation (make sure no one is around!).
- Once you are comfortable with this exercise, contract and relax your muscles for 10 seconds at a time, three times in a row. Ten is the maximum number of contractions for one set of pelvic floor muscle training for optimal results; repeat two or more sets per day. Make sure that you do not tense your face or body while contracting your muscles; hold this relaxed contracted position while doing these exercises.
- For those that experience severe pain or discomfort while doing these Kegel exercises, make an appointment with your doctor as soon as possible, as they may be experiencing a more serious condition that needs medical attention.
What are the risk factors with pelvic organ prolapse surgery?
Risks of prolapse mesh when applied transabdominal vs. transvaginally: In transvaginal repair, the risk is increased for urinary and bowel obstruction and chronic pain with attempts at intercourse. A study from Harvard medical school shows that synthetic material used in pelvic meshes may not be as safe for use in women as previously thought.
In a study of four different brands (Gynemesh PS, Alyte, Restorelle, and UltraPro – all considered anisotropic ) of synthetic mesh, the researchers found that the synthetic material used in pelvic repair is degraded over time by a natural enzyme called collagenase.
The results show that the material is more likely to break down in the vaginal connective tissue through that site than through the abdominal tissue, elevating prolapse symptoms. In a meta-analysis of randomized trials done on patients who went for repair prolapse using an anisotropic mesh (Alyte, Gynemesh, Restorelle) performed transabdominally, the overall complication rate was 21.1% vs. 64.7% in patients who had it performed vaginally.
If the mesh is not searchable, complications can range from pelvic pain near the pelvic area, bowel control issues, dyspareunia, vaginal opening complications, bleeding and/or hematoma, and/or bladder perforation.
If the mesh is exposed to vaginal fluids, the risk may be increased for the development of a bacterial vaginosis infection or reinfection of Trichomoniasis. The long-term risks of mesh erosion into the bladder are unknown but have been seen in case studies following transvaginal placement of mesh (10-21%).
Lastly, if surgical treatment is performed vaginally, there is a risk of ureteral injury to both ureters, which may lead to hydronephrosis and kidney failure due to obstruction, for which medical intervention would be necessary for normal position to resume.
Recently, we’ve seen some well-publicized lawsuits against transvaginally placed prolapse meshes: J&J’s Ethicon lawsuit was the biggest single product suit in 2016, at $12 billion with 9000 cases filed. And now Kimberly-Clark’s Ethicon addition for a transvaginally placed sling has been added to the growing list of lawsuits, with over 4000 cases filed.
Known Pelvic mesh injuries include:
- Organ perforation. The most common complication with transabdominal mesh is erosion, which occurs when mesh pieces move beyond the intended location. The erosion can cause painful intestinal problems if the affected tissue has to be removed.
- Erosion of pelvic organs. Pelvic organ perforation is another potential transabdominal mesh complication that can occur when the organ itself becomes caught between pieces of the mesh.
It is very important to recognize the symptoms of mesh erosion, which is the most common complication with transabdominal mesh, which include:
- Discomfort or pain during sexual intercourse due to prolapsed organs
- Unexpected vaginal bleeding and urine leakage
- Shortness of breath, chronic coughing, or chest pain
- Bleeding from the surgical site
If any of these symptoms occur, patients should contact their physician immediately. Surgery may be needed to remove the mesh.
- Mesh shrinkage
- Mesh infection
- Pain during sex
- Scarring or adhesions that obstruct the urinary tract or bowels
- Numbness in the vagina and anus. This is common when the bladder drops
- Obstruction and pain in the vagina and anus due to scars from multiple surgeries
- Fecal incontinence and prolapse from an inability to hold stool in the rectum
Some other complications might not become apparent until months or even years after surgery. It’s important to keep track of any reactions you experience after pelvic organ prolapse surgery to tell your doctor if they get worse over time. Depending on the procedure you have, possible risks may include:
- Anesthesia complications
- Bladder injury
- Neurological complications
- Bowel injury
- Blood clots
- Recurrent prolapse
- Blood transfusion if you have severe bleeding
According to the National Association for Continence, the risks of surgery also may depend on your overall health and other factors. Talk with your doctor about ways to minimize your risk and for ideal surgical options. You also can talk with a certified diabetes educator to learn more about the risks if you have diabetes. The outlook for pelvic organ prolapse surgery depends on the severity of your symptoms and whether you had previous surgery.
To reduce the risk of complications or “wrongful surgery,” you should make sure that you meet with your surgeon and;
- Ask plenty of questions beforehand, including surgical options and if they offer longer support.
- You should be able to determine if the doctor has adequate experience and training to perform this particular surgery. If your doctor is not ready to provide medical advice, they may not be the best source to help you after your surgery.
With that being said, you will want to be sure that your doctor is board-certified in general surgery, gynecology, and urology and has extensive experience with pelvic organ prolapse procedures. They should also attend a minimum of two training programs per year to ensure that they stay up-to-date on the latest techniques and technologies.
One thing to notice is that the mesh, whether it is placed transvaginally or transabdominally, surrounds the vagina:
If fibrosis takes place, then this plastic mesh hardens, becomes rigid, and can saw through the tissue to enter the vagina, causing pain to both the woman and partner during sex.
What are the available legal options for people who have been injured by transvaginal or transabdominal mesh for POP repair?
With such a wide range of symptoms and risks, patients who have developed complications from transvaginal or transabdominal mesh have several legal options. The first step to getting the help you need is learning how to report pelvic mesh injuries. Here are some steps you should take if you were injured during pelvic mesh surgery:
- Step 1 – According to National Association for Continence, you should learn how your injury occurred – When it comes to pelvic mesh implants, too many women receive the same advice: accept the medical device implanted in you as a condition of receiving treatment for a painful pelvic condition. Such an approach is not informed consent. The failure to outline the risks and alternatives and warn of the risks of serious health conditions caused by the mesh devices themselves is a major cause of pelvic mesh injuries.
Victims need to review their medical records and consult with experts, such as Tom Plouff, Chicago IL attorney, to fully understand how their injuries occurred and how they may proceed with litigation and other legal remedies. Plouff has handle a number of pelvic mesh cases, including being the trial attorney on behalf of a woman who obtained a $35 million veridict in a transvaginal mesh case, Prolift, against Ethicon ad Johnson & Johnson. Plouff has an impressive track record of multimillion dollar jury verdicts. As of February 2022, Plouff has scheduled for trial a transabdominal Coloplast Restroelle Y mesh (for POP repair) case in March 2022, and another transabdominal mesh Restorelle XL mesh case in June 2022. A pelvic mesh injury attorney is a good source source that a victim can turn to if they want to get the full and final word on pelvic mesh injuries.
For example, Tom Plouff an experienced trial attorney Chicago, IL, will review your case to determine what is best for your needs and to help you decide what legal options may be best for you. The following reasons you may have a wrongful surgery lawsuit:
- You had an unnecessary operation
- The surgeon left something inside of you during pelvic organ prolapse surgery
- The surgeon made a mistake during a hysterectomy
- The surgeon did not inform you of risks associated with pelvic organ prolapse surgery or hysterectomy
- No consent was obtained before the operation
Call Tom Plouff, a Chicago-based attorney, now for your consultation and learn how he can help you hold the negligent doctor and hospital responsible for the damages caused by pelvic organ prolapse surgery. Tom Plouff Chicago IL is a leader in pelvic organ prolapse (POP) lawsuits and has a nationwide team of attorneys and medical experts who have collectively recovered more than $150 million for POP-related injuries.
For example, In March 2022, Plouff is set to go to a jury trial in federal court in Hammond, IN, the same place he obtained a $35 million verdict on Prolift, on a Coloplast Y mesh case on behalf of Rebecca Martinez. Plouff, a Chicago-based attorney, is also set to go to trial in state court in Indianapolis, IN, in a Coloplast XL mesh case on behalf of a woman injured from transabdominal mesh.
That is the case on behalf of Melissa Little, in which case the court denied summary judgment to Coloplast, so the case will go to trial in Indiana in June 2022.
- Step 2 – Consult with your doctor(s) and/or physical therapist(s). Don’t be afraid to ask questions or express concerns. Be proactive in seeking treatment. It’s important to not be afraid to ask your doctor questions, express concerns or seek a second opinion if you don’t feel comfortable. The more information you have, the better equipped you’ll be to make the best decision for your health and well-being.
- Depending on the device you received, you may need follow-up surgery. You must follow up with your surgeon and have them examine you to ensure everything is OK. If you have concerns, it’s always best to ask than suffer in silence.
- Step 3- Don’t ignore your symptoms. Do not delay recovery treatments due to lack of medical payment coverage. You may have fallen prey to a fraudster who has convinced you to sign up for medical coverage that does not exist.
- If you have been taken in and sent for medical tests or treatment, but you are not sure whether or not the insurance is valid, take a step back and think. The following points may be helpful. Don’t be afraid to try to verify the information on your own. See if any of the provided contact details work or put in your calls to hospitals and clinics in the area.
- Step 4- Join in the discussion: The thought of joining the discussion about vaginal mesh is often enough to get someone to walk away from any potential lawsuit. They feel like they aren’t victims, so why would anyone else care about their opinion. However, joining the discussion is beneficial for everyone. When you join a discussion or forum related to vaginal mesh and vaginal mesh injury, there are several ways to feel better.
- The first way you will feel better is if you feel less alone. You are not alone in this situation, and it can be hard to realize that when you keep everything bottled up and within yourself. When you join the discussion(check pelvic floor disorders network right here), you realize that others have experienced the same types of issues that you are experiencing right now with vaginal mesh, either with different products or the same products. Victims of vaginal mesh injuries should contact Tom Plouff, Chicago IL attorney, for more information on their legal options.
- Step 5 – Understand that the financial recovery will provide compensation for all related damages, including your medical bills, lost wages, disability benefits, etc. The most important and substantia component of damages are past and future pain and sufereing and past and future loss of a normal life.
In the end, what is important is that you keep your head up and stay strong if you are. You have every right to be compensated for your injuries from your surgeon’s negligent performance. You have a team of professionals on your side that will help you get through this difficult time. By investing in legal representation, you will ensure that you are protected and compensated for the harms you have suffered.
We understand that this time is stressful and difficult, but rest assured that there is a light at the end of the tunnel. If a faulty pelvic mesh implant has injured you or anyone you know, contact Tom Plouff, Chicago IL attorney, today for help.