Transvaginal mesh is a medical device, in a fibrous, net-like form that is implanted to treat stress urinary incontinence and pelvic organ prolapse in women. Though the device was approved by the FDA, the design and techniques used for implantation has contributed to serious events and complications such as organ perforation and tissue erosion.
Surgical mesh transplants have been used for hernias and other disorders requiring surgical support. In the past, most surgical mesh was made of biologic tissues such as human or bovine connective tissue. Today, transvaginal mesh is most commonly made of a plastic-like substance known as polypropylene which has been coated with biological materials in order to reduce the chances of side effects.
Transvaginal surgical mesh was intended to permanently repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP). SUI and POP are conditions that most often arise in women after hysterectomy, childbirth or menopause. SUI is the inability to hold urine if physical stress is experienced (lifting, bending) or through stress created by POP. Pelvic organ prolapse occurs when the pelvic muscles of a woman weaken, allowing the pelvic organs including the uterus, bladder and rectum to protrude or sag into the vagina.
The surgical technique used to implant the device is “transvaginal” or through the vagina. Mesh to repair POP and SUI can actually be surgically placed transvaginally or abdominally (through an abdominal incision), however the vaginal route is faster, less complicated and considered to be less invasive as incision is not frequently required.
These devices were created to help women who suffer from POP and SUI and were approved by the FDA. Despite this, not all of them have been safe and effective. Some manufacturer designs and recommended implantation techniques have contributed to infections, vaginal tissue erosion, and organ perforation along with other complications including worsened and possibly permanent urinary incontinence.
In 2010 alone, more than 75,000 women received a transvaginal mesh implant, however more than 10 percent of these surgeries resulted in failure. Similar results were seen in other years and unfortunately for many women, reports of complications came too late to prevent injury.
The FDA has reviewed scientific research regarding transvaginal mesh placement for procedures performed over the 15 year period of 1996 to 2011. The results of the investigation showed that transvaginal mesh procedures caused greater risks than non-mesh repairs and that many of the transvaginal procedures did not successfully repair pelvic organ prolapse.
Nearly 40 thousand lawsuits have been filed on behalf of women who have been injured by transvaginal mesh in the U.S. District Court for the Southern District of West Virginia alone, and many more are pending in other state courts. Unfortunately for many women, reports of complications came too late to prevent injury.
History of Transvaginal Mesh
Transvaginal mesh implantation devices were developed from surgical mesh that had been used for hernia repair since the 1950s. Traditionally, surgical mesh used for hernia repair was constructed of collagen extracted from bovine or human tissue and formed into a mesh that could be implanted.
The biologic construction allowed the body to incorporate and attach new tissue directly to the mesh. In the beginning stages of the use of surgical mesh, surgeons utilized the same biologic mesh which was then cut to the shape and size needed for the specific patient.
Manufacturers of medical devices quickly developed new products which had been specifically designed to treat stress urinary incontinence. The first manufacture was Boston Scientific with the ProtoGen Sling. It had been approved in 1996 by the FDA but was recalled due to safety concerns just three years later.
1998, Ethicon released Tension-Free Vaginal Tape (TVT) for stress urinary incontinence and the products known as “mesh” also began being called “tape” or “slings”. The first mesh designed to treat pelvic organ prolapse was Gynemesh PS, released in 2002, and was also designed by Johnson & Johnson’s Ethicon subsidiary.
The AMS Apogee Kit for SUI were approved for use in 1997 and quickly followed by The AMS Perigee kit for POP, both manufactured by American Medical Systems, now a subsidiary of Endo Health Solutions which also has heavy involvement in the pharmaceutical industry.
Some physicians and healthcare research institutes have determined that the introduction of the kits was the beginning source of the problems associated with transvaginal mesh.
Design of Transvaginal Mesh
Transvaginal mesh implantable medical devices are used to treat conditions caused by weakened pelvic muscles in the female patient.
They are categorized by the FDA into 4 types:
– considered to be a permanent implant as it will remain in the body indefinitely unless removed. This type of mesh implant is mad entirely of synthetic materials such as plastics or polyesters. The most common type of synthetic material used for non-absorbable synthetics is polypropylene which is used for 91 percent of synthetic meshes in this category.
– will lose shape and strength over time as it degrades and is absorbed by the body. It is not intended as a long-term or permanent implant but under normal conditions it is expected that the patient’s own body will grow new tissue at the site of the implant to keep the repair intact.
– derived from natural animal tissue that has been extracted and disinfected for reformation into a mesh. These products are usually comprised of bovine (cow) or porcine (pig) tissue but can be made from human tissue. As the product degrades, it is expected that the patient’s own tissue will grow at the new site.
– made of a combination of any of the two above types.
Synthetic mesh materials are woven into a number of different shapes, depending upon their potential use. FDA guidance has suggested that larger-pore; lightweight mesh will reduce the inflammatory response of the body and has therefore become the standard.
Conditions Treated by Transvaginal Mesh Procedures
Pelvic Organ Prolapse
– happens when a pelvic organ such as the bladder or uterus drops (prolapses) from its normal position in your abdomen into the lower portion of the abdomen and may begin to press on other organs. This happens because the muscles and ligaments holding the pelvic organs can get weak or stretch from childbirth, surgery or as menopause progresses. Most women have some type of prolapse but not all need treatment. POP can also be caused by obesity, long lasting cough, constipation that happens on a regular basis causing straining and some types of pelvic organ tumors. In some cases, the doctor may be able to prescribe exercises but in other cases, surgery may be advised.
Stress Urinary Incontinence
– urinary incontinence (loss of bladder control) caused by physical movement such as lifting, running, coughing, laughing, or sneezing. It happens because these activities put physical pressure onto your bladder, which has been weakened due to medical or natural events such as pregnancy or childbirth, surgical procedures, menopause or other conditions. The doctor may be able to suggest some non-surgical remedies but in some cases, surgery will be advised.
– a hysterectomy, either partial hysterectomy which has removed only the uterus or a total hysterectomy which has removed both the uterus and ovaries, can cause falling of the pelvic organs as the uterus is no longer there to support them. Hysterectomy is a common cause of POP and SUI and should be considered a risk factor for a requirement for suspension or sling surgery.
Serious Adverse Events and Complications of Transvaginal Mesh
Transvaginal Mesh Erosion
– the mesh that is implanted during the transvaginal mesh procedure can erode through the vaginal wall. This can eventual result in organ perforation and can require additional surgery, sometimes multiple surgeries to repair. In addition, in some cases the damage cannot be repaired. Once inside the vaginal area, the mesh can shrink or contract causing pain during intercourse or an inability to have intercourse and/or generalized pelvic pain that is severe. It may also cause bleeding that cannot be easily controlled. In addition, the original condition may return (SUI or POP) as the problem has not been repaired.
Transvaginal Mesh Organ Perforation
– If the mesh erodes a portion of the vaginal wall, it may actually perforate the vagina. This exposes the patient to intense pain, severe bleeding, and possible infection. Transvaginal mesh has the potential to erode and perforate other organs as well, though these are not that common. Any organ close to the location of the transvaginal mesh implantation may be subject to damage from the mesh.
Though not as immediately severe, transvaginal mesh can also cause:
- Urinary tract infections, in some cases infections may be chronic and require continuous antibiotic treatment
- Vaginal scarring which can thicken the vaginal walls, making intercourse painful or impossible and also creating generalized vaginal discomfort or pain
- Need for additional surgeries as problems caused by transvaginal mesh may require surgery to treat them and the patient may require corrective surgery to treat the original problem that has not been cured.
- Nerve damage causing recurrent pain or loss of sensation
- Vaginal shrinkage related to mesh shrinkage or vaginal scar tissue shrinkage resulting in pain and discomfort
- Neuromuscular problems related to pain a difficulty moving and nerve damage affecting other areas
- Emotional problems related to the continuous need to have additional surgeries and physical exams and possible permanent disability
Mesh Revision Surgery
Revision surgery may be required to correct the original condition in cases where the transvaginal mesh procedure has not worked. This affects over 10 percent of all patients who have received the transvaginal mesh implant. Revision surgery, or multiple surgeries may also be required to correct physical problems caused by the implant itself. Each additional surgery exposes the patient to additional risks of bleeding and infection and successive surgeries may not always “fix” a botched procedure.
Transvaginal Mesh and the FDA
The FDA does not appear to have required adequate testing before issuing approval to transvaginal mesh manufacturers. In addition, many of the devices that are on the market for use today were approved based on the first sling type device, ProtoGen Sling. The ProtoGen Sling device was recalled in 1999 by the FDA after it was found that the device did “not appear to function as intended” and had “higher than expected rate of vaginal erosion” occurrences.
Dr. L. Lewis Wall, Urogynecologist published an American Journal of Obstetrics and Gynecology article regarding the ProtoGen Sling, stating that it “had never been implanted in a human vagina prior to its clearance”. The FDA did not look more closely at transvaginal mesh until after a number of independent physicians conducted clinical trials of their own. Study results revealed a high risk of complications.
FDA Activities regarding Transvaginal Mesh since damages became more apparent in 2008:
- 2008 October – Public Health Safety Notification issues warning about complications of transvaginal mesh for SUI and POP but maintains that complications are rare.
- 2011 July – Update to 2008 Public Health Safety Notification issued, stating that complications are NOT RARE. Also stating that it is “not clear that transvaginal POP repair with mesh is more effective” and “may expose patients to greater risk” than non-mesh repair.
- 2011 September – Obstetrics and Gynecology Devices (OGD) Panel of the Medical Device Advisory Committee is organized by the FDA.
- 2012 January – FDA orders that manufacturers of transvaginal mesh devices must conduct additional, post-marketing studies based on recommendations of the OGD Panel.
- 2012 February – FDA orders 34 manufacturers of POP mesh devices to conduct 95 post-marketing studies, FDA orders 7 manufacturers of SUI mesh devices to conduct 14 post-marketing studies to evaluate safety and adverse events
- 2013 March – FDA Web pages are updated to include more information regarding adverse events occurring related to mesh used for SUI.
Transvaginal Mesh Lawsuits and Settlements
Nearly 100 thousand transvaginal mesh lawsuits have been filed on behalf of women and family members against major medical device manufacturers involved in marketing of transvaginal mesh products. Over 40 thousand lawsuits have been filed in the U.S. District Court for the Southern District of West Virginia alone, including six federal multidistrict litigations overseen by Chief Judge Joseph R. Goodwin.
Companies named in the multidistrict litigations include:
- American Medical Systems
- Ethicon, a subsidiary of Johnson & Johnson
- Boston Scientific
- Cook Medical Inc.
- C.R. Bard
- Coloplast Corp
Lawsuits have claimed that:
- Companies misled the FDA, medical community and the public at large regarding the safety and efficacy of transvaginal products
- Companies failed to conduct appropriate testing and research to determine risks of surgical mesh used for female pelvic disorders
- Companies failed to establish methods that are safe and effective for removal of transvaginal mesh implants
- Companies concealed knowledge that their products could cause permanent and debilitating injuries
- Companies had a legal duty to insure the safety and effectiveness of their products but provided false and misleading information
Notable cases and settlements:
- Bakersfield, CA couple were awarded a jury verdict of $5.5 million against C.R. Bard (2012)
- Atlantic City, NJ woman was awarded a jury verdict of $3.35 million against Ethicon / Johnson & Johnson (2013)
- Charleston, WV woman was awarded a jury verdict of $2 million against Bard. (2013
- An undisclosed number of lawsuits were settled by an agreement to pay $54 million by Endo Health Solutions, parent company of American Medical Systems (June 2013)
- Bloomberg News reported in 23013 that some manufacturers were in discussions for an out of court settlement of up to $30 thousand per claim, however no such agreement has materialized.
- More than 40 transvaginal mesh products are named in the federal lawsuits. Judge Goodwin has set individual trial dates for each company / product (as the defendant).