Are Mesh Implants Safe?

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The use of mesh implants for the transvaginal repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) became the favored method of several pelvic surgeons starting in the early 2000’s. The popularity of surgical mesh for the repair of these pelvic floor disorders encouraged a number of medical device companies to market mesh implants in kit forms.

While transvaginal repairs using mesh implants were regarded as less invasive and requiring only a shorter recovery period, problems started to surface in the middle of the decade. Thousands of women complained of experiencing serious injuries after being implanted with these vaginal mesh devices.

By 2008, the Food and Drug Administration (FDA) had to issue a Public Health Notification informing healthcare providers and patients of the complications associated with mesh implants. It provided recommendations on how to lessen the risks and how to counsel patients.

Complaints of severe complications continued to mount in the ensuing years, prompting the FDA to issue anew a Public Health Notification on July 13, 2011. Based on the 2,874 Medical Device Reports and supported by results of various clinical studies, the Agency this time issued a notification informing the public of the risks involved with mesh implants used in transvaginal repairs of POP.

Unlike its first advisory, the FDA announced that it had determined that complications involving the use of mesh implants were not rare. It further declared that the use of mesh implants for urogynecologic procedures does not conclusively improve clinical outcomes over the so-called tradition non-mesh procedures.

What Are the Complications Associated with Mesh Implants?

After a thorough review of the Medical Device Reports and assessment of scientific literature, the FDA was able to determine a number of adverse events associated with the use of vaginal mesh implants. It reported that mesh erosion, also known as exposure, extrusion, or protrusion, continued to be the most common adverse effect. It warned that this complication may require multiple surgeries and may result to continued pain even after the removal of the mesh implant.

Following mesh erosion, severe pain including dyspareunia or painful sexual intercourse, chronic infections, and vaginal bleeding were identified as the other common complications.

The agency also highlighted the possible occurrence of mesh shrinkage or contraction which may result to vaginal shortening or tightening causing extreme pain to the patient.

Below is the list of adverse effects attributed to vaginal mesh implants:

  • Mesh erosion through the vagina (known also as mesh exposure, extrusion, or protrusion)
  • Chronic pain (including dyspareunia or painful sexual intercourse)
  • Severe infections
  • Vaginal bleeding
  • Mesh contraction or shrinkage (vaginal shortening/tightening)
  • Organ perforation
  • Urinary problems
  • Neuro-muscular problems
  • Recurrent prolapse/incontinence
  • Emotional problems

What to Do When Injured by A Mesh Implant?

Women who had undergone surgical procedures using mesh implants are encouraged to have a regular consultation with their doctors and be on the alert for any possible complications. If symptoms consistent with mesh complications are experienced, it is crucial to immediately have it checked by a pelvic medicine specialist who will conduct a detailed examination to ascertain the real cause.

Appropriate measures may be recommended by your doctor once your condition has been diagnosed correctly. Depending on the gravity of the damage, she may prescribe medications or recommend a surgical procedure to remove the mesh implant.

It has been acknowledged that mesh removal or mesh excision is a very complicated and difficult procedure which may involve a lot of risks. In choosing a surgeon to do the mesh removal, it is important to get the services of those who are highly experienced on this type of operation.

From experience of other victims, numerous surgeries may be required without any guarantee that the condition may be remedied. This has caused so much pain and suffering to women who only wished to have a better quality of life.

In addition to the pain and suffering, a patient may be burdened with expenses for medications, consultations, use of medical facilities and of course the loss of past and future income.

This has left victims of mesh implants no other recourse but to take the necessary legal actions to protect their rights and to be compensated for any losses incurred.

Should you take the same course of action, it is important to have the legal assistance of a highly qualified, experienced, and competent lawyer.

Summary of Updates on Mesh Implant Lawsuits

Litigation of vaginal mesh lawsuits in the United States has been moving quite well so far. The filing of lawsuits continues in different courts across the country. It has been estimated that the number of claims against mesh manufacturers may exceed the 50,000 mark, making it one of the biggest product liability controversy in history.

It has been noted that developments in the legal front have been favorable to the mesh victims. Three lawsuits have been resolved in favor of the claimants after the juries found the mesh manufacturers liable for the injuries suffered by the plaintiffs. Christine Scott in California was awarded $5.5 million, Linda Gross with $11.1 million, and Donna Cisson with $2 million.

In addition to these jury decisions, there have been three instances where out-of-court settlements were concluded. C.R. Bard agreed to settle the claims of Wanda Queen and Melanie Virgil while Endo Solutions, the parent company of American Medical Systems, allocated $54.5 million for the settlement of selected vaginal mesh lawsuits.

It was reported in September 2013 by a reliable online media source that settlement talks between five major mesh manufacturers involved in a West Virginia multidistrict litigation (MDL) and thousands of plaintiffs are ongoing. Mesh companies allegedly involved in these talks are C.R. Bard, Boston Scientific, American Medical Systems, Coloplast, and Cook Medical.

While these negotiations continue, trials dates for a number of vaginal mesh claims have been scheduled for the end of the year and early next year.

What Is A Mesh Implant?

A transvaginal mesh implant is defined as a screen-like medical device used in surgical procedures to repair urogynecologic disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). This device has also been referred to as mesh graft, bladder sling, bladder tape, bladder mesh, pelvic mesh, polypropylene mesh, and transvaginal mesh device.

As distinguished from a procedure done through the abdomen, a transvaginal mesh surgery means the repair of POP or SUI is done with a mesh implant through the vagina. Hence, the name transvaginal mesh implant.

While there may be other types of materials used as mesh implants, the most common is the non-absorbable synthetic type using polypropylene. This man-made material accounts for over 80 percent of all mesh implants used for pelvic floor repairs. Being non-absorbable, this material does not degrade and may be considered a permanent implant in a woman’s body.

The four categories of surgical mesh materials are the following:

  • non-absorbable synthetic (e.g., polypropylene or polyester)
  • absorbable synthetic (e.g., poly(lactic-co-glycolic acid) or poly(caprolactone))
  • biologic (e.g., acellular collagen derived from bovine or porcine sources)
  • composite (i.e., a combination of any of the previous three categories)

What Are The Uses Of Mesh Implants?

Surgical mesh was originally used by surgeons in the treatment of hernia conditions by implanting the mesh through the abdomen. The use of this device was later adapted by pelvic surgeons in treating patients with pelvic organ prolapse (POP) and stress urinary incontinence (SUI) by cutting the mesh into sizes that fit the requirements of the patients.

Pelvic organ prolapse (POP) is a pelvic floor disorder wherein a pelvic organ such as the bladder, uterus, small bowel, and rectum drops or descends from its normal position towards the vaginal wall. This may cause a bulge in the vaginal wall or may even protrude into the vaginal opening. This occurs when the pelvic floor support made up of muscles, ligaments, and tissues are weakened or damaged due to several factors.

It estimated that over 34 million women worldwide are affected with this condition. It is believed that one out two women over the age of 45 may experience this condition.

Stress urinary incontinence (SUI), the most common pelvic floor disorder, is characterized by the involuntary release of urine during movements that increase the intra-abdominal pressure which in turn increases pressure on the bladder. Activities or movements that may trigger this include coughing, laughing, sneezing, lifting, running, and jumping.

In 2010, it was reported that there were over 18.6 million American women diagnosed with SUI. A recent study has also shown that the risk of requiring surgery to treat this urinary problem increases to 20 percent by the time a woman reaches 80 years of age.

What Are The Procedures Using Mesh Implants?

Surgical procedures using transvaginal mesh implants may actually be classified under two categories. One will be that for pelvic organ prolapse (POP) which generally uses a larger mesh implant and that for stress urinary incontinence (SUI) which is more commonly known as a sling procedure.

While both types of procedures may be similar in that they are performed through the vagina and use mesh implants, POP repairs are done using mesh implants configured to match the anatomical defect of the patient. The mesh implants may be placed in the anterior (front) part of the vaginal wall to repair bladder prolapse, posterior (back) portion to repair rectal prolapse, and at the top (apical) of the vagina for uterine and vaginal vault prolapse.

Sling procedures for SUI generally use small mesh implants intended to provide support to the urethra or bladder neck. There are three types of procedures that are favored by most surgeons.

The retropubic procedure or known as TVT slings is done by making a small incision in the vagina just under the urethra and then making two small opening just above the pubic bone. The TOT or transobturator approach is very similar to that of the TVT slings but differs in that the arms are not passed through the pubic bone but through the groin or thighs. The third approach which is the mini sling uses a shorter mesh implant and is done with only one incision.

References:
meshmedicaldevicenewsdesk.com
bloomberg.com/news/2013-09-30/bard-vaginal-mesh-makers-said-to-be-in-settlement-talks.html
fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
rcog.org.uk/files/rcog-corp/2013-03-20_Pelvic_organ_prolapse.pdf
emedicine.medscape.com/article/447951-overview
medicinenet.com/script/main/art.asp?articlekey=116460
thewomens.org.au/meshinvaginalprolapsesurgery
meshsurgeons.com/
wvsd.uscourts.gov/MDL/