Pelvic organ prolapse sounds very dramatic. The prolapse of anything should be cause for concern, especially in the pelvic area. Women have been suffering from this condition since 2000 B.C., and up to 30-50% of women are going to develop POP in their lifetimes (with 2% becoming symptomatic). When organs are not where they’re supposed to be, treatment is very necessary. Let’s discuss why.
The pelvis is full of a complex web of muscles, organs and ligaments.
Pelvic organ prolapse, also called POP, is when muscles and ligaments supporting organs in the pelvic area (the bladder, uterus and rectum) become weakened. They start to sag, which creates a bulge — or a prolapse — in the vaginal space. This can happen after childbirth, menopause or a hysterectomy, though women with a family history of POP, those who are obese, or aging women are also at risk for developing it. Even asthma or constipation can trigger a prolapse because they put more pressure on the intra-abdominal area.
POP can either be asymptomatic, meaning the condition can occur with no physical symptoms, or symptomatic. Those with mild symptoms might have feelings of constant heaviness, or an increase in pressure after exercising or being on their feet all day.
Severe symptoms include vaginal bleeding, pain, difficulty urinating or defecating, and pain during sexual intercourse.
Severe cases can include patients experiencing protrusions of tissue from their vagina. POP can occur simultaneously with other pelvic floor disorders, so medical professionals will likely test for all other similar problems as well.
Doctors categorize POP in five categories, with Stage 0 meaning no prolapse and Stage 4 meaning that organs are completely outside the body. The condition is diagnosed by physical testing, cystoscopy (viewing of the interior lining of the bladder and urethra), urodynamic tests (how urine is expelled from the body), a CT scan, or an IVP (intravenous pyelogram, a type of X-Ray to show size and position of the organs).
POP can affect more than one pelvic organ. For instance, weakness of the front side vaginal wall can result in a cystocele, or a dropped bladder. An enterocele is a weak spot in the vaginal ceiling, which causes uterine prolapse. Weakness of the back vaginal wall near the rectum can result in a rectocele. These can happen at the same time. This is why it is imperative that doctors know exactly which area is exhibiting weakness before determining how to proceed.
There are currently no medications for POP (other than pain or nerve medications, which can be used off-label to treat this), but there are several other treatments available.
If your doctor thinks that you are asymptomatic, he will likely take a “wait and see” approach. If you are experiencing symptoms (like discomfort, heaviness or protruding tissue), any of the following might be recommended:
It should be noted that there is a 30% recurrence rate for women who choose surgical options for POP. Surgeons are also experimenting with vaginal grafts, both synthetic and biologic, as an alternative solution for this condition.
Transvaginal mesh has long been considered a treatment for POP because the medical community said it would extend the life of any repair.
While the product was originally inserted through the abdomen, in the 1970s surgeons began doing transvaginal surgeries for pelvic organ prolapse. Until 2002, surgeons would literally cut the piece of mesh for each specific patient. That year, however, the first surgical mesh kits specifically for POP were approved by the Food and Drug Administration. By inserting the pre-made mesh screens, doctors were able to support sagging muscles. Tissue would grow around the implant, rooting it in place.
The FDA keeps track of adverse events with the MAUDE database (Manufacturer and User Device Experience), through which both doctors and patients can report their medical outcomes. After reviewing more than 3,979 reports in a three-year period, they noted that up to 10% of women with POP who were treated with surgical mesh experienced erosion (also called exposure, extrusion or protrusion, meaning the mesh was not where it was supposed to be).
While morbidity rates were not extreme, there were three deaths associated with POP mesh surgery during 2008 to 2010 (the results of two bowel perforations and one hemorrhage). They also received complaints of:
After researching the results of those 3,979 women, the FDA stated that:
There have been so many issues and reports of adverse effects that in 2016, the FDA reclassified surgical mesh for POP surgeries as a Class III medical device, which is the category associated with the highest risk. Medical device companies must now seek premarket approval before selling mesh kits designed for POP surgeries.
You should discuss the pros and cons with your surgeon. The FDA provides a handy list of questions, including “Will my partner feel the mesh during intercourse?” and “If I develop complications, can you remove the mesh?” (Surprisingly, not every surgeon who inserts mesh can remove it.)
Some women don’t experience issues after being inserted with surgical mesh for pelvic organ prolapse. It adheres to the correct area, encourages tissue growth and isn’t painful. Those are the lucky ones.
Other times, there are severe complications. It can take years for issues to develop, though the average seems to be three to four years (one woman’s implant worked for 18 years before slicing her urethra).
Some women live in extreme pain or are even bed-ridden. Others injure their partners when having intercourse, if they’re even able to have sex, because eroding mesh can cut the other person. Problems with mesh are “not rare,” and many women wish they had known more before trying this surgery, especially because very often it cannot be removed.
Mesh is designed to encourage tissue growth, so removal can require multiple surgeries or be physically impossible. Some can’t sit for longer than an hour or have vaginal bleeding. They have also reported other nebulous physical problems like chronic low-back pain or leg pain, difficulty walking, incontinence and more.
Additionally, because mesh is made of propylene, a type of plastic, it can harden from body heat. That transforms it from the pliable, cushy implant to what feels like your screen window is how organs become perforated. This is a huge point of contention between manufacturers and patients, because medical device companies claim that the implant is inert, while patients report that it is not (thus becoming biologically incompatible with the body).
The British Society of Urogynaecologists keeps a database of adverse events, and at an international meeting they were called out by the International Continence Society for not reporting their data per health guidelines. They even called BSUG’s participation “generally poor.” When numbers are not being reported, determining the actual efficacy of mesh in treating pelvic organ prolapse is impossible. Other trials have been too short or not applicable (like companies that only test on animals prior to distribution).
This is why we must go with what we know, which is a colloquial account of what a patient experiences after surgery. In 2011, the FDA said the following:
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh. While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
This is why so many women are now suing medical device companies. Read more about lawsuits and complications.
If you think you have a claim against a transvaginal mesh company after treatment for pelvic organ prolapse, you should read the following:
There is no question about this — yes, you should. Products liability lawsuits (also known as defective products) are full of depositions, interviews, expert testimony and mountains of evidence. The medical device company has millions of dollars readily available, with which they can throw up any number of roadblocks. An attorney with experience in this area knows how to deal with companies like these.
Either your lawyer files a motion to transfer your case into an existing multidistrict litigation (or MDL, which is like a class-action lawsuit), which would save money on pretrial aspects of the case; or the Judicial Panel on Multidistrict Litigation can order you to transfer into an MDL if there are common questions of fact.
Personal injury lawyers do not work on retainer. Lawyers work on a contingency fee and should take a third of the proceeds, plus costs (filing, copying, etc.). That may increase if you go to trial (a normal number is 40% in that instance).
All legal fee agreements have a line that says “Past performance does not indicate future rewards.” This means that nobody can promise you anything. Lawyers can offer a range, telling you which clients got A and how many got B. Some cases go to trial and a jury awards damages; others settle prior to a verdict. Those settlements have reached $20 million for a single plaintiff, like the one against Ethicon. However, other plaintiffs have had their cases dismissed on the merits (meaning they had no evidence). All of this means that nobody can predict anything.
You will be talking about your vagina to anyone who asks. It will take a few years to finish up the lawsuit, and in that time you will be deposed (put under oath and asked questions by opposing counsel about your health issues). If the case proceeds to trial, you will likely have to testify. Joining a lawsuit means having patience and knowing that you might have to discuss your private problems in open court. At the very least you will undergo independent medical examinations, which are doctors’ appointments with a medical professional chosen by the defendant.
You need to do what’s right for your body. While filing a case might feel like a betrayal to your surgeon, you still need to take care of yourself. A good surgeon will support you (since really, it wasn’t his fault; it’s the mesh’s fault). The surgeon will almost definitely be called as a witness. If he is experienced, he will have played the game before.
However, in a few cases medical malpractice may come into the picture. If your doctor or surgeon was negligent, you can also pursue a case against them.
If you are feeling pain at your implant site, the first thing you do should be to speak with your surgeon. It is most critical to fix any immediate health problems before going further.
Once you have done that, then get a lawyer. Many women feel more comfortable with a female attorney, as these cases involve intimate areas. You can also try a Google search:
“Tennessee defective products OR products liability attorney POP mesh”
This will filter your results, since Googling “mesh implant attorney” will end up giving you thousands of web pages. Be sure to modify using your own state instead of Tennessee.
How do you know if an attorney is the right one for you? Read online reviews to pick the best lawyers. Then, once you’ve picked a few, speak with them in person. You can interview each one and decide if he or she is able to help. Only by talking face to face will you be able to determine the best of the bunch.
Also, keep in mind that each state has a statute of limitations (the time window in which you can file your case). Once that time is up, you are barred from filing a claim for your pelvic organ prolapse mesh complications. A few states only offer one year for personal injury cases, so if you must, get any attorney to file your claim and then choose a new lawyer for the more complicated aspects of the case.
Products liability law is difficult. You need an experienced attorney who knows how to work with pending multidistrict litigation cases. If you have not met with a lawyer yet, try the Enjuris directory for someone in your state who can help you bring a transvaginal mesh lawsuit.
Next article: Transvaginal mesh basics – background to the lawsuits
Return to the main vaginal mesh lawsuits guide