Transvaginal mesh implants are becoming one of the most controversial medical implants in recent years. Their original use was to treat pelvic organ prolapse and stress urinary incontinence, and transvaginal mesh has been a commonly used device since its approval by the FDA in 2002.
Several years after FDA approval, severe side effects directly caused by the mesh implant began to affect patients and transvaginal mesh lawsuits followed. Manufacturers have been brought into thousands of mesh implant lawsuits with new transvaginal mesh lawsuit that claims to be continuously still being filed. Transvaginal mesh attorneys can fight for the rights of those who have experienced side effects of a transvaginal mesh device and litigate a transvaginal mesh claim for financial compensation for injuries related to the implant.
Transvaginal Mesh Implant Procedures
Transvaginal mesh procedures are used to support or strengthen internal organs. The implant is first inserted into the body through the vagina to support the pelvic organs. Next comes a small incision made in the vaginal wall to accommodate the mesh. The transvaginal mesh is then attached to the weakened or sagging organ through sutures or staples. The idea is for the mesh to provide adequate support for the weakened organ.
Although surgical mesh devices have been used for many years, the transvaginal use only began in the 21st century. The FDA approved transvaginal mesh in 2002, and after approval, other manufacturers entered the market in large numbers with their own transvaginal mesh system. Transvaginal mesh went from unused, to being used in nearly 100,000 surgeries annually only a few years after the initial FDA approval. Five U.S. manufacturers, as well as European maker Coloplast, sold the device in the U.S.
Transvaginal Mesh Implant Repairs
The main use of surgical mesh is to treat urogynecologic procedures, which includes the repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant, which ideally should reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. The three main surgical procedures that are performed using surgical mesh to treat pelvic floor disorders are:
- Transvaginal mesh to treat POP
- Transabdominal mesh to treat POP
- Mesh sling to treat SUI
Transvaginal Mesh Complications
Vaginal mesh implants have been the direct cause of many severe side effects. One type of mesh created for hernias has been in use since the 1950s, but it has been known to shift in the patient’s body or cause infection, which has led to tens of thousands of lawsuits. Transvaginal mesh devices are similar in how they cause infection and shift within the body, which can cause severe injuries and complications that are even more dire than experienced with hernia mesh devices.
Some reports of potential vaginal mesh complications originated in the early part of the century, and by 2008 there were roughly 1,000 reports of injuries and side effects caused by transvaginal mesh complications suffered by women who had been treated with the mesh implant. The public eventually realized that the mesh devices were not safe, and legal action followed suit.
The reports stated that pelvic mesh specifically was the cause of multiple side effects and complications. Every vaginal mesh side effect is dangerous and has the potential to turn into a serious problem. Transvaginal mesh reports show the following side effects and injuries in women:
- Transvaginal Mesh Erosion – The mesh can degrade over time. This means that the mesh can fail, or the eroding mesh material can cause harm elsewhere in the body.
- Organ Perforation – The mesh can shift position. When that happens, it can come into contact with other organs and damage them to the point of perforation.
- Infection – The mesh is made out of material claimed to be inert, but in some instances, it has been the site of reactions.
- Pain During Intercourse – The mesh can still be felt in the body during intercourse.
- Bleeding – The implant can irritate and rub against organs, causing internal bleeding.
Transvaginal Mesh Device Statistics
- During a period from 2005 to 2010, there were over 4,000 reports of complications arising from the use of transvaginal mesh devices.
- The FDA in 2008 released a statement that warned of potential complications but asserted that these complications were rare.
- In 75,000 transvaginal mesh surgeries performed in 2010, 10% of those implanted with the devices reported complications.
The estimated range of transvaginal mesh complications are from about 10 percent to as high as 40 percent over all procedures. The vaginal mesh complications are debilitating and can cause lasting harm, but most of the side effects are not life-threatening. However, there were media reports in the United Kingdom alleging that a woman who died from sepsis had contracted an infection from a transvaginal mesh implant. There were also reports of seven deaths between 2008 and 2010 linked to these devices. The FDA had no choice but to change its classification of transvaginal mesh to high-risk by 2016 and recently on April 16th, 2019, the FDA halted all sales of transvaginal mesh products.
The FDA Halts The Sale of Transvaginal Mesh
The FDA officially ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately on April 16, 2019. The FDA’s decision rests on the fact that companies in the marketplace have not proved that the product is safe for long-term use. The FDA also stated that women who have had the product utilized in procedures did not need to have it removed, but should consult their doctor and make sure that they are watching for potential warning signs or injuries. According to the FDA, women should continue with annual checkups as a safeguard against these severe side effects.
Surgical Mesh Lawsuit Settlements
Women who have been injured or experienced side effects from transvaginal mesh complications can file a lawsuit against the company that created the product. This is classified as a product liability lawsuit. If successful, plaintiffs may receive the following:
- Compensation for pain and suffering
- Reimbursements for past and future medical bills
- Lost wages if surgical mesh complications caused missed work
- Loss of consortium
- Punitive damages against the manufacturer if there was an element of misconduct
There have been roughly 73,000 product liability claims filed as of January 2018 against those who have manufactured or sold transvaginal mesh products. The amount of pelvic mesh lawsuits continues to expand as more and more patients start to experience the negative side effects associated with transvaginal mesh products. The statute of limitations begins from the time the patient the device was used on knew or should have known to the best of their ability that they were injured. It does not begin with the date that the mesh was implanted. Because of this, patients who received the mesh years ago can still file a suit, so long as the injury did not occur until the applicable period. Considering that this device is a “ticking time bomb” implanted in a woman’s body, it’s likely that as time goes on, more lawsuits will arise.
Surgical mesh lawsuits are classified as product liability claims against the manufacturer. A vaginal mesh lawsuit will have to prove that the product was defective in some way and that the plaintiff suffered injuries or side effects directly from the product and its defect. Transvaginal mesh product lawsuits have made these assertions in the past:
- The product was defective, so the manufacturer should be held liable for the harm suffered under any and all circumstances.
- Transvaginal mesh was defectively designed, causing it to either shift or degrade.
- The product was defectively manufactured, causing complications that women suffered.
- The makers of this product knew or should have known of the side effects, yet they failed to warn patients before they were implanted in their bodies.
- The defendants were negligent in designing and making the product.
- Transvaginal meshes violated warranties by not working for their intended purposes, which was to treat pelvic organ prolapse and stress urinary incontinence.
Transvaginal Mesh Settlements
Because of the multitude of lawsuits against them, some of the manufacturers of these products entered into a settlement of the claims that have been filed against them. Endo International plc, the company who originally purchased the manufacturer of transvaginal mesh, settled the claims against transvaginal mesh for $2.6 billion. They fully cooperated to cease making and selling the mesh. Several other manufacturers, including Coloplast, have also settled their cases.
Larger manufacturers have fought the cases brought against them in court, an example being Johnson & Johnson, who sells vaginal mesh products through its Ethicon subsidiary, facing several verdicts against their product. Johnson & Johnson has settled thousands of cases involving their mesh implant and has had jury verdicts settled for as large as $35 million. Boston Scientific, another large manufacturer of transvaginal mesh products, had a $100 million verdict, however it was later reduced to $10 million.
Contact a Transvaginal Mesh Complications Lawyer
The Eichholz Law Firm has experience in lawsuits where a defective medical device causes an injury. These cases require the skill and knowledge of a reputable lawyer because they require analysis of scientific evidence and the likely testimony of expert witnesses. The manufacturers of these products, who are dealing with thousands of transvaginal mesh lawsuits will never admit fault, as they want to pay as little as possible. If the defendants make a settlement offer, it will likely be on their terms in order to pay less. In this situation, a transvaginal mesh attorney is imperative to protect the plaintiff’s financial needs. Contact The Eichholz Law Firm or fill out our online application for a case evaluation, so we can advise you on your next steps to securing a settlement because of your transvaginal mesh injury.
- FDA. “Urogynecologic Surgical Mesh Implants“, U.S. Department of Health and Human Services, https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/. Accessed April 23rd, 2019.
- Mayo Clinic. “Get the facts about transvaginal mesh complications“, Mayo Foundation for Medical Education and Research, https://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300. Accessed April 22nd, 2019.
- Gopal H. Badlani, Hemendra N. Shah. “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review“, US National Library of Medicine National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424888/. Accessed April 22, 2019.
- Matthew Goldstein. “As Pelvic Mesh Settlements Near $8 Billion, Women Question Lawyers’ Fees“, The New York Times, https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html. Accessed April 22, 2019.
- Department of Surgery, Division of Urology.”The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics“, Female Pelvic Medicine & Reconstructive Surgery, https://journals.lww.com/jpelvicsurgery/Abstract/2018/01000/The_Truth_Behind_Transvaginal_Mesh_Litigation__.4.aspx. Accessed April 22, 2019.