Vaginal Mesh Lawsuits
Vaginal Mesh Complications: Transvaginal Procedure Puts Pelvic Organ Prolapse Repair Patients at Greater Risk
Women who suffered mesh complications after undergoing pelvic organ prolapse repair surgery with a trans vaginal mesh may have legal recourse. On July 13, 2011, the FDA announced that patients undergoing pelvic organ prolapse repair with a surgical mesh may be at a greater risk for mesh complications than women pursuing other surgical treatments. Because the manufacturers of trans vaginal meshes failed to warn patients and doctors about this increased risk, women suffering mesh complications may be able to file a claim seeking compensation for medical bills, pain and suffering and other damages.
Vaginal Mesh Complications: Eroded Mesh, Infection
Pelvic organ prolapse (POP) repair surgery can be performed through the abdomen or the vagina, using stitches or a surgical mesh to reinforce the repair and to support the pelvic organs. According to the FDA, the transvaginal placement of the surgical mesh may put women at a greater risk for POP mesh complications than other surgical options. In addition, the agency claims that with the exposure to greater risk comes no indication of greater clinical benefit in women electing to undergo pelvic organ prolapse repair surgery transvaginally.
The following are among the vaginal mesh complications reported by women who underwent pelvic organ prolapse repair surgery with a trans vaginal mesh:
- Mesh erosion
- Pain during sex
- Urinary problems
- Vaginal scarring
- Bowel, bladder and blood vessel perforation
The FDA first alerted the public to these trans vaginal mesh problems when it released a safety communication in 2008 regarding the complications associated with the trans vaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI). In the vaginal mesh complications safety announcement, the agency claimed that in the past three years it had received more than 1000 reports of mesh complications from nine different manufacturers. Since then, the number of mesh complications reported to the agency has increased; from 2008 to 2010, the agency received more than 1500 reports of mesh complications stemming from pelvic organ prolapse repair surgery, five times as many as it had received between 2005 and 2007. However, these reports of mesh complications did not always indicate whether the patient underwent POP surgery through the abdomen or the vagina.
Lawyers for Vaginal Mesh Problems
In light of the FDA mesh warnings, pelvic mesh attorneys are currently available to review claims of vaginal mesh complications from women who were implanted with many types of vaginal meshes and bladder slings, including but not limited to the following:
- Avaulta Vaginal Meshes (Biosynthetic, Plus and Solo)
- Gynecare Prosima, TVT, Gynemesh and Prolift products
- Mentor ObTape
- Bard Pelvic Meshes (PelviSoft, PelviLace and Pelvicol products)
- AMS Mini Arc Single Incision Sling
- AMS BioArc, Elevate, Perigee and Apogee
- Tyco IVS
- Boston Scientific Arise, Pinnacle, Advantage Fit, Lynx, Obtryx, Prefyx PPS and Solyx
Potentially, these individuals may be able to seek compensation for medical bills, pain and suffering and other damages resulting from their mesh problems. Fill out our free case review form today and our vaginal mesh lawyers will evaluate your claim, at no cost to you, to determine if you can participate in a vaginal mesh lawsuit. There is a time limit for filing vaginal mesh lawsuits, so do not hesitate to contact us today.
Complications : Mesh Erosion, Infection, Bleeding, Incontinence, Painful Intercourse and more
Transvaginal surgical mesh implants or slings, which have been implanted in millions of women in urogynecologicprocedures to repair pelvic organ proplase (POP) andstress urinary incontinence (SUI), have been linked to a high rate of serious mesh complications. Women throughout the country have filed transvaginal or pelvic mesh lawsuits seeking compensation for serious injuries, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection, pain and emotional distress.
Surgical pelvic mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In extreme cases, the vagina can even fall to the point where the vagina is outside of the body. Mesh can be placed to repair prolapse of the following pelvic organs: bladder (cystocele), top of the vagina (apical prolapse), uterus (procidentia), rectum (rectocele), bowel (enterocele) and urethra.
Stress urinary incontinence (SUI) is an involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise. Stress urinary incontinence (SUI) may occur as a result of weakened pelvic muscles that support the bladder and urethra. The condition is most common in women who have had multiple pregnancies and vaginal childbirths, and who suffer from pelvic organ prolapse (POP). The implanted mesh or sling is intended to work as a hammock which will support the prolapsed organs and to address the symptoms associated with POP and SUI.
Transvaginal and Pelvic Mesh Complications and Failures
Adverse events from pelvic mesh implanted transvaginally may include:
- Erosion of the mesh through the vaginal tissue
- Exposure or extrusion of mesh, which can require multiple surgeries
- Feeling a lump in the vaginal opening or something protruding from vagina
- Painful sexual intercourse (dyspareunia).
- Perforation or puncture of the bladder, intestines and bowels, as well as blood vessels around the vaginal wall
- Recurrent Pelvic Organ Prolapse (POP)
- Urinary problems
- Vaginal bleeding
- Vaginal chronic drainage, discharge and infections
- Vaginal pain
- Vaginal scarring and shortening
In many cases, women require surgical excision to remove the mesh or sling and may even require two or three additional surgeries. Despite removal of the mesh, complications may not be reversed, and women continue to suffer with vaginal pain and an impaired quality of life.
Transvaginal Mesh Lawsuits
Victims of vaginal mesh implant and sling failures who file a transvaginal mesh lawsuit may be able to collect damages for:
- Additional surgery and multiple surgical revisions
- Emotional distress
- Loss of ability to have sexual relations
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and Suffering
- Spousal loss of consortium
Pelvic mesh lawsuits have been filed on behalf of women around the country against several manufacturers of transvaginal mesh (TVM) and sling devices for POP and SUI repair including:
- American Medical Systems: Sold under the names Elevate, Perigee and Apogee
- Boston Scientific: Sold under the names Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System
- C.R. Bard, Inc.: Sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace
- Johnson & Johnson/Ethicon: Sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima and Gynecare TVT
As the U.S. Food & Drug Administration (FDA) continues to investigate the safety risks, complications and failures of surgical mesh implanted transvaginally to treat POP and SUI, it is expected that the litigation surrounding transvaginal mesh products complications and painful side effects will only continue to grow
Transvaginal Mesh Timeline
Nov. 15, 1996: The Food and Drug Administration (FDA) gives Boston Scientific clearance for ProteGen through the 510(k) route, a process that allows devices onto the market without a substantial amount of clinical testing as long as the manufacturer can argue that it is similar enough to a previous device, referred to as a predicate. Boston Scientific’s evidence was based on 3 month rat study, and cited predicates such as hernia slings and fabric used for cardiac surgery. The ProteGen is the first transvaginal mesh device targeted to treat incontinence.
Jun. 1998: The FDA inspects a Boston Scientific manufacturing plant and finds that problems with the device are worse than reported, failing to cite certain cases of serious medical complications. The agency stated, “"During the inspection, it was learned that the number of events being reported is approximately two-thirds of the complaints being made to the firm,” according to The Star Ledger.
Aug. 18, 1998: Despite the results of the previous inspection, there is no solid reason for Boston Scientific to issue a recall, the FDA says in an investigation report.
1998: Johnson & Johnson wins clearance for Gynecare TVT through the 510(k) route, citing Boston Scientific’s ProteGen as a predicate.
Jan. 22, 1999: Boston Scientific recalls the ProteGen, stating that the device “does not produce outcomes that are consistent with the company's standard of performance for its products or customer expectations.” cites The Star Ledger. Reportedly, the company received complaints of pain during sexual intercourse, discomfort and vaginal tissue erosion. Despite the acknowledged failure, the recall does not affect J&J’s Gynecare TVT device, nor any following devices based on either of these products.
2003: Boston Scientific settles 738 lawsuits over its vaginal mesh device. The amount is undisclosed.
2005-2007: The FDA receives over 1,000 reports from nine different manufacturers citing frequent complaints such as erosion of vaginal tissue, pain, infection, urinary problems, and recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), the original problems that were supposed to be treated. Reports also included instances of bowel, bladder and blood vessel perforation during the initial procedure.
Oct. 20, 2008: The FDA issues a Public Health Notification warning about the serious complications related to transvaginal mesh implants used to treat SUI and POP, citing the numerous reports received from 2005-2007. At this time, the agency says that the complications are rare, but potentially serious.
Jan. 1, 2008- Dec. 31, 2010: The FDA receives 2,874 additional reports concerning the complications associated with the mesh implants used to treat POP and SUI. Common complaints included vaginal erosion, pain, infection, bleeding, painful sexual intercourse, urinary problems organ perforation. Reports also included cases of emotional problems, vaginal scarring and shrinkage, neuromuscular difficulties and recurrence of POP symptoms.
2010: An FDA-estimated 300,000 women receive transvaginal mesh implants.
Jul. 13, 2011: The FDA releases an update on its previous Public Health Notification regarding the safety risks associated with vaginal mesh implants. The update cites the reports received between 2008-2010, stating that the complications are in fact not rare, as previously announced in 2008. The update also notes that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Sept. 2011: An FDA advisory panel recommends that vaginal mesh implants used to treat POP should be reclassified from moderate-risk to high-risk. The reclassification would force manufacturers to conduct studies based on human testing.
Jan. 2012: The FDA orders 33 manufacturers, including J&J and C.R. Bard, to conduct 3 year studies to assess the impact of transvaginal mesh implants on organ damage and other serious complications.
Jan. 2012: Industry manufacturers are faced with over 650 lawsuits alleging that the device caused a host of painful injuries.
Feb. 7, 2012: The U.S. Judicial Panel consolidates three multidistrict litigation (MDL) cases into one. Lawsuits filed again J&J’s Ethicon Inc., American Medical Systems and Boston Scientific are set to be centralized before U.S. District Chief Judge Joseph R. Goodwin in the Southern District of West Virginia.
Transvaginal Mesh Complication Victims - Legal Help
If you or a loved one suffered painful injuries as a result of POP or SUI repair that involved a vaginal mesh implant, you may have valuable legal rights. To learn more about obtaining compensation for transvaginal mesh injuries, please fill out our online form today.