In 2011, the FDA issued a statement that warned women of the risks associated with transvaginal mesh. The FDA’s statements stated that the risks when inserting a vaginal mesh outweigh the potential benefits. The mesh was cleared without clinical trial data requirements that other drugs are subjected to.

The transvaginal mesh is a semi-permeable barrier that can be implanted by a physician into a woman that has experienced complications with pelvic organ prolapse. The mesh is designed to keep internal organs in place.
Pelvic organ prolapse is a condition where a woman’s pelvic organs protrude through the vaginal opening. Pelvic organ prolapse can occur in women that have had multiple childbirths or a hysterectomy. The bladder is the most common organ that can prolapse, but others such as the urethra, uterus, vagina, small bowel, and/or the rectum slip can also slip out of place.

Women who experience complications have been subjected to mesh erosion, painful sex or dyspareunia, mesh migration, mesh shrinkage, risk of infection, incontinence and/or internal bleeding.

If you have experienced pain, infections, bladder or urinary problems, or other serious side effects due to vaginal mesh surgery, contact a LegalView attorney for a case consultation.

Dr. David Grimes, M.D., a board-certified surgeon in obstetrics and gynecology and preventive medicine, has expressed that vaginal mesh complications should not be left for the FDA and manufacturers to determine the best course of action.

Dr. Grimes, whose credentials also include distinguished research scientist at FHI360, a global development organization, emphasizes that surgeons and doctors are also responsible in informing patients about the potential risks and side effects associated with transvaginal mesh surgery.

He stresses that vaginal mesh surgery “is industry-driven technology,” where the lack of critical appraisal has allowed the approval of medical devices that deserved more scrutiny. For example, the FDA, which currently approves medical devices like vaginal mesh using its 501 (k) process, has been the subject of controversy, as some of the devices used to approve current products on the market have been recalled.

“What we need are better standards not just within the FDA but within the professional community,” says Dr. Grimes.

However, Dr. William Maisel, M.D., Deputy Director and Chief Scientist of the FDA’s Center for Devices and Radiological Health (CDRH) clarifies that the FDA cannot really regulate the practice of medicine. Although the FDA does not “think transvaginal mesh should be routinely used for pelvic organ prolapse repair,” it does not really want to lessen options for patients because they believe that “that some patients really do need mesh.”

The manufacturers advocate this opinion. A spokesman for mesh manufacturer Ethicon, a Johnson & Johnson company, called its use in treating pelvic organ prolapse and stress urinary incontinence “an important option for many patients.”

Because some medical professionals view vaginal mesh as a viable alternative, it is up to the surgeons and doctors to ensure that each and every patient understands the risks and potential dangers. Women suffering from incontinence or a pelvic organ prolapse need to be aware of the risks of mesh shrinkage or erosion, and it is up to their doctor to adequately provide them with this information.

Read more about vaginal mesh complications at LegalView.

The review team from the Food and Drug Administration (FDA) presented data on the safety and effectiveness of surgical mesh used on Pelvic Organ Prolapse (POP) and mesh suburethral slings used for surgical management of female Stress Urinary Incontinence (SUI) during an open-public hearing in September 2011. The FDA team showed that safety and effectiveness of vaginal mesh devices are not well-established and proposed that the surgical mesh devices must be reclassified.

Approximately 1,700 different generic types of devices are classified and then assigned to a group. There are 16 medical specialties referred to as panels, which are assigned to respective groups for review. A class to which a device is placed determines the requirements that must be met before a manufacturer may distribute the device in interstate commerce. The classes are:

1) Class I General Controls (With Exemptions and Without Exemptions)
2) Class II General Controls and Special Controls (With Exemptions and Without Exemptions)
3) Class III General Controls and Premarket Approval.

Vaginal mesh devices are under Class II. This means that general controls alone are insufficient to assure safety and effectiveness and existing methods are available to provide such assurances. Class II devices need to comply with special controls which may include special labeling requirements, mandatory performance standards and postmarket surveillance.

If vaginal mesh devices are reclassified to Class III, they will be considered as devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Hence, premarket approval (or a scientific review to ensure the device’s safety and effectiveness) will be mandatory. Further, Post Market Surveillance Studies will have to be imposed. This study will evaluate the safety and effectiveness of the device.

Manufacturers oppose this proposal simply because it will mean additional expenses on their production. This will also delay release of their products to the market which will mean lagging behind sales and profits.

There’s still debate whether reclassification will make an impact. But certainly, women who are now faced with the reality of mesh erosion, mesh shrinkage, or any other vaginal mesh complication could only hope this proposal came earlier.

The health problems that transvaginal mesh surgery is supposed to fix is not uncommon and they have been with us for hundreds of years. The conditions, including pelvic organ prolapse, hernias and urinary incontinence, have pushed the medical community to find more effective treatments. Studies have shown that POP and SUI can be caused by weakened pelvic muscles due to childbirth or surgery, however obesity is a contributing factor.

Vaginal mesh was introduced as a surgical treatment option for these health concerns. Although surgical mesh was used successfully in some hernia surgeries, the growing statistics of reported complications resulting from transvaginal mesh surgeries is saying otherwise.

Mesh erosion and mesh shrinkage is now a growing threat to women who have undergone vaginal mesh surgeries. The numerous lawsuits filed by different women in different places across the U.S. revolve around these two side effects intertwined with vaginal mesh devices.

And are these side effects serious? Very.

Mesh erosion, where the vaginal mesh moves or migrates from the spot where it was implanted, and mesh shrinkage, which is the change in size of the mesh device, have pushed patients to assert their rights in court against the makers of the mesh devices.

Much to the dismay of many, mesh erosion and mesh shrinkage have led to different results like extreme pain, discomfort, painful intercourse, and even additional surgeries. Before these devices flooded the market, mesh erosion and mesh shrinkage were unknown threats to women, which has only made an unfortunate situation even worse.

Read more about vaginal mesh injuries, mesh erosion, and mesh shrinkage at LegalView.

Vaginal mesh is no longer the “gold standard” when it comes to treating pelvic organ prolapse (POP) and urinary incontinence (SUI). Several other treatment options are available.

Common treatmens include a vaginal pessary, Botox, and non-mesh surgery.

A VAGINAL PESSARY is a plastic device that fits into the vagina and serves to support the uterus, vagina, bladder or rectum. What makes it different from a transvaginal mesh implant is that a pessary is not surgically inserted into the vagina. Instead, it is a removable device that, depending on the degree of prolapse, can be taken out after a period described by the physician. Use of pessary, however, has also known side effects like odorous discharge, which can be solved by cleaning the pessary with soap and water. Sexual intercourse is not hampered by the use of this device. Other minor side effects include changes in bowel movement or difficulty in urinating, both of which can be treated by changing the size of the pessary.

BOTOX, or Botulinum Toxin A, involves injecting the bladder with botox to treat incontinence and urinary symptoms caused by an overactive bladder. Side effects of Botox are minor – headaches, diarrhea, slight fever, or abdominal pain, but easy to treat.

LAPAROSCOPIC SURGERY is a minor surgical proceedure used to treat urinary incontinence. An incision is made to let the laparoscopic instrument (which has a tiny digital camera) in the area where a defect is determined. Sutures and stitches will then be made. One downside of this prodecure is that the rate of recovery depends on the tissues and muscles themselves, and may sometimes require doing additional stitches.

Unlike vaginal mesh, the U.S. Food and Drug Administration has never issued any health and safety communications for these procedures. Do they have side effects? Of course. No surgery is really guaranteed to be without any side effect. But are the side effects of these vaginal mesh alternatives serious as in vaginal mesh? No.

Women who reported vaginal mesh erosion and mesh shrinkage are not as fortunate because the side effects of vaginal mesh are far more serious than that of the alternative treatments. The rising number of lawsuits against manufacturers of vaginal mesh devices are clear proof of the risks that these devices can create.

If you have undergone vaginal mesh surgery and have experienced side effects, consult your physician immediately. Read more about vaginal mesh complications at LegalView.

The legal departments of Johnson & Johnson Inc., Ethicon Inc. and American Medical Systems Inc. may need to work more thanks to a recent lawsuit filed in Texas against the three vaginal mesh manufacturers.

Cathleen Ankenman and her husband John, filed a lawsuit before the Eastern District of Texas regarding the vaginal mesh injuries she suffered. Ankenman claims that almost three years after she was implanted with a vaginal surgical mesh, either Gynecare Prolift + M or the AMS Monarc, to treat a pelvic organ prolapse, she has had to undergone three corrective surgies.

The plaintiffs accuse the giant manufacturing companies for fraudulent concealment, fraudulent misrepresentations, negligence, breach of warranties, among others.

Had she been told, three years ago, that the implant surgery will lead her three more corrective surgeries, more medical expenses, mental and physical pain, and a tedious lawsuit, she would have refused to be implanted the device immediately.

The issue the plaintiff raises is fair. Some vaginal mesh products on the market today were not tested before they were approved for use. Instead, they were approved by the FDA’s 501(k) approval system, which compares the new product to a similar product currently on the market. However, some of these similar products have since been recalled.

Although the FDA has issued warnings about vaginal mesh due to increasing reports of mesh erosion and mesh shrinkage, many women are unfamiliar with other treatment options, such as vaginal pessaries.

One could only imagine how difficult it would have been for a woman to have a diminished, if not lost, capacity to work, piling medical expenses, and perhaps disrupted marital intimacy, all because she was not told what could happen.

Reports about and lawsuits directly connected to vaginal mesh injuries is rising. Read more about transvaginal mesh lawsuits at LegalView.

Pelvic organ prolapse (POP), Stress Urinary Incontinence (SUI), hernias, pelvic floor repair  and other health anomalies are the most common reasons why women undergo mesh surgery. In the U.S., more than 300,000 patients go through surgery to cure POP or SUI. With the introduction of vaginal mesh devices in the market, many women pinned their hopes on a better, more efficient treatment.

But as the controversy about transvaginal mesh complications grows hotter, it seems as though these women have hoped in vain.

A pelvic organ prolapse (POP) occurs when the bladder, uterus, large intestines, or the urethrapelvic organs push through the pelvic wall and descend from their natural place.

Types of POP include:
1. Anterior vaginal prolapse (cystocele) – where the wall between the vagina and bladder detaches from the pelvic bones.
2. A posterior vaginal prolapse (rectocele) is when the rectum bulges out of the vagina.
Normally, the vaginal wall could hold these organs in their proper place. However, childbirth could cause the muscles and tissues around the vaginal wall to weaken. Surgery, like hysterectomy (removal of the uterus), can also lead to POP or SUI. Prolapse can be made worse by obesity, frequent constipation, and even long-lasting coughs.

Since its invention, vaginal mesh has been a top treatment choice for these conditions over other methods. The conventional surgery for POP and SUI involved stitching together tissues and muscles in the vaginal wall and let the resulting scar be the support of the wall. This kind of surgery depends heavily on the individual healing capacity of each patient. That means, some patients recover faster than others.

Manufacturers of these mesh devices have convinced many that the mesh devices promise higher rate of fixing POP and SUI. However, many women have reported that their vaginal mesh surgery didn’t fix the problem they were supposed to. This is in addition to reports about infections, mesh erosion, mesh shrinkage, and further surgical intervention that these patients had to go through. A clinical study showed that use of vaginal mesh devices has another consideration: the stage of prolapse or descent. The vaginal mesh does not really guarantee to work for a more severe stages of prolapse, thus the need for additional surgeries and corrective operations.In light of this, not only did the vaginal mesh manufacturers break their promise to provide treatment of POP and SUI, they also added burden to the patient.

We encourage you to clarify this with your physician. Read more about vaginal mesh complications at LegalView.

Vaginal mesh devices are one of the modern innovations introduced as an alternative surgical treatment for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). However, in the FDA Health and Safety Alert concerning transvaginal mesh devices, it mentioned that patients have reported experiencing mesh erosion.

What is mesh erosion?

POP and SUI have been treated by stitching the muscle tissues in the vaginal wall together. The vaginal wall is naturally sturdy, able to support the other organs located around the abdomen. But due to child birth or surgery, the pelvic muscles surrounding the abdomen weaken and are unable to provide support.

Vaginal mesh was designed as an additional surgical treatment option – a mesh device is implanted to provide support for the organs and allow the tissue to grow into the device. Theoretically, the tissues should heal first and not let the mesh device move in the process. Problems arise when the mesh device erodes even before the tissues heal.

Vaginal mesh erosion can be experienced few weeks after surgery. One cause may be due to incorrect placement or a defective mesh device. Also, because the vagina is not a sterile surgical environment, infections during the healing period can cause the mesh to erode. Patients are usually given 5 weeks or more to wait for the tissues to heal. Some patients may lose track of this period and engage in sexual intercourse within this time which can also cause the vaginal mesh to erode.

Some patients reported having foul-odored discharges a few weeks after surgery. This may be a sign of infection, or mesh erosion, or both. Some patients reported feeling pain or discomfort, urinary problems, or recurrence of prolapse and incontinence. These are signs of vaginal mesh erosion.

Mesh erosion would require one or more surgeries to correct it; either to remove a part of the eroded material, or to remove the entire device.

It is very important that the physician or the surgeon was able to explain thoroughly the possibility of a mesh erosion to the patient. This is a very serious complication as this will lead to more health risk and more surgeries for the patient.

Women put their hopes in what pharmaceutical manufacturers of mesh devices promise. You will know that this promise is not kept when you are experiencing the symptoms of mesh erosion. LegalView offers free consultation to guide women on how to deal with a vaginal mesh erosion claim.

Vaginal mesh shrinkage (or contraction) is one known cause of complications and injuries reported by women who underwent vaginal mesh surgery. These medical innovation known as a vaginal mesh device started to be used for Pelvic Organ Prolapse (POP) and hernia. Ideally, the device is supposed to support the vaginal wall, which in turn supports the organs surrounding the organ. This should prevent the other organs from moving from their natural position. Vaginal mesh shrinkage, or contraction in a more clinical term, is exactly what it is — shrinking of the device.

It is not so difficult to imagine what effect shrinking will lead to, especially when it is used as a support. Imagine a post in your house, shrinking. Naturally, the weight it carries will have to eventually collapse. This is vaginal mesh shrinkage.

In a journal published by the The American College of Obstetricians and Gynecologist in 2010, it showed that vaginal mesh shrinkage is a known complication of vaginal mesh surgeries. But this is not the most frightening thing about it. The journal said in its discussion that the origin “of this phenomenon is still unknown.”

Here are some theories explaining how vaginal mesh shrinkage may occur:

Some researchers say that the shrinkage  may be a physical consequence of the inflammatory response to the mesh, that is, the body’s inflammation pushes the foreign material causing it to shrink.  Others theories that it may be a result of inadequate tissue in-growth into the mesh. Whatever the reason is, the journal concludes that shrinkage becomes very high when the material is introduced into a biological tissue. Using imaging techniques such as ultrasonography or magnetic resonance imaging, the researchers saw that the dimensions of the graft were assessed after the surgery, and compared with the original mesh device before the surgery.

Again, these are just theories.

In a study presented at the 34th Annual Scientific Meeting of the International Urogynecological Association,  it was shown that long-term changes in mesh volume found mean contraction of 30 percent, 65 percent, 85 percent from its original size. This was seen after follow-up durations of 3, 6, and 8 years, respectively. The study thus showed that the shrinkage is progressive and there is a linear evolution of the contraction rate with time, raising the worrying possibility that mesh contraction syndrome will be more frequent. This is but just an observation, and as discussed, there is really no definite explanation yet about shrinkage in vaginal mesh devices.

Common signs associated with shrinkage is pain and discomfort and dyspareunia (painful sexual intercourse). The study also showed that surgical intervention is necessary to avoid further complications caused by vaginal mesh shrinkage.

Had patients knew this, would they have proceeded with their transvaginal mesh surgery? Or would have the physician encouraged these women had they known this? None can tell definitely. But the fact remains the manufacturers of these mesh devices are obliged to have known all of these findings before they introduced these devices into the market.

If you feel you are experiencing vaginal mesh shrinkage, consult a physician immediately. Also, LegalView can give you legal advice, free of charge, to let you know your rights as a patient.

Read more about transvaginal mesh injuries at LegalView.