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.

Recently, the United States Food and Drug Administration called for stricter regulations against hip replacements and vaginal mesh.

Under the current medical device approval process, manufacturers only have to prove that their products are substantially similar to those already on the market before getting pre-market approval. These products can be approved for patient use even if the previous, similar product has been pulled from the market, or is under review for recall. Right now, the Food and Drug Administration does not have any authority in every case, which has led to several devices being used by patients that could be harmful.

Many women who have received transvaginal surgical mesh have experience several complications including: pain, infection, bleeding, and most commonly, mesh erosion, where the mesh erodes into surrounding tissue, making it very difficult to remove.

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.

Transobturator tape procedure (TOT) can be effective for the treatment of stress urinary incontinence (SUI), but there has been little research done on the safeness of this procedure. Follow-up for these types of studies is only about two-years and any complications could be underreported.

A study performed by researchers at the University of Geneva in Switzerland studied 253 women who underwent TOT with three different types of slings (Aris®, Obtape®, and TVT-O®). The follow-up for this study was at 27-months and follow-up was available for 96.6 percent of the women studied.

Researchers found that 29.4 percent of women experienced erosion of the sling and 21.3 percent of the participants experienced late complications, including de novo, or worsening of preexisting urgencies. However, over 70 percent of women were satisfied with the procedure and complications were low.

Transobturator tape procedure is an alternative to vaginal mesh, which has been linked to higher rates of serious complications.

Jay Nevarez, a mother-of-three from Colorado, had no idea that the device that was inserted into her pelvis was very similar to one that had been recalled nearly a decade ago because of severe complications, including persistent pain and infection.

What did she have implanted? She had a trans vaginal surgical mesh, a medical device that has come under scrutiny by the United States Food and Drug Administration (FDA) and many others.

Nevarez has filed suit against Johnson & Johnson/ Ethicon, the maker of the Gynecare TVT implant, which was automatically approved based on its similarity to another product. That product manufactured by Boston Scientific was removed from the market shortly after the Gynecare TVT was approved.

Representative Edward Markey (D-MA) is trying to change this. According to him, there is a loophole in today’s legislation that allows certain medical devices to be approved for market use even if there is reason to believe they may harm others. Markey is putting forth a bill that would strengthen the FDA’s regulations on medical devices.

In the meantime, however, Nevarez is still in constant pain and according to her, has lost everything, including her health, her job, and is in the process of losing her home.

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.