Vaginal Mesh Recall Lawsuit – Surgical Mesh Implant Erosion
If you have developed serious complications following a surgery involving transvaginal mesh, contact our product liability lawyers for a free and confidential consultation by filling out the online form below, by calling my office directly at (215) 948-2718 or toll-free (844) 459-8719. I’m also of counsel with TorHoerman Law, the nationwide product liability firm that negotiated the $2.4 billion Actos settlement and the $650 million Pradaxa settlement.
My most recent article on this subject is The FDA Is Doing Too Little, Too Late About Transvaginal Mesh.
This website answers frequently asked questions about the transvaginal mesh complications and the law, including:
- What happened?
- Which vaginal mesh products are affected?
- Who might have a claim?
- What steps has the Food and Drug Administration taken?
- Has there been a recall of transvaginal mesh?
- What scientific studies have been done to determine the safety of implanted vaginal mesh?
- Is there a class action lawsuit against the makers of vaginal surgical mesh?
- How did this happen?
- What is pelvic organ prolapse?
Medical studies have shown that the vaginal mesh used by surgeons and gynecologists to repair pelvic organ prolapse (like cystocele or urethrocele) and to treat urinary incontinence has a much higher rate of serious complications (particularly erosion of the mesh through the vagina) than previously claimed by the mesh manufacturers, and so patients who suffered those complications have begun filing lawsuits to obtain compensation for their injuries.
Unfortunately, even many doctors don’t understand the nature and scope of the problem. We have seen many OB/GYNs “treat” vaginal mesh erosion by doing nothing more than prescribing premarin estrogen cream and telling the patient their problems are mostly psychological. If you have the symptoms below, you’re not alone — we represent dozens of women who, just like you, have had what was supposed to be a “routine” surgery turn into a living nightmare. We can help you find treatment and obtain compensation.
Which vaginal mesh products are affected?
Most reports have come from:
- Gynecare, Gynemesh, or Ethicon (made by Johnson & Johnson);
- Avaulta, Pelvicol, and Pelvisoft (made by C.R. Bard);
- Advantage Sling, Obtryx, Perfyx, Pinnacle and others (made by Boston Scientific Products);
- Spar, Miniarc, Monarc, Apogee, Perigee, Elevate (made by American Medical Systems) meshes; and,
- MPathy, Mentor-Aris, Supris, Suspend, T-Sling, Novasilk, Exair, Restorelle, and Virtue (made by Coloplast A/S).
Any surgical mesh used to repair pelvic organ prolapse or stress urinary incontinence is at a risk of erosion, failure, and the need for repair.
Put simply, the use of surgical mesh as a treatment in the vaginal and pelvic area has never been adequately tested to ensure it is effective and safe. In 1990s, gynecologists started using surgical mesh for their procedures, and soon thereafter medical device manufacturers used the “510(k) clearance” loophole (discussed more below) to get the FDA to approve their use without testing. Shockingly, the pelvic mesh that is causing concern now is substantially similar to the “ProteGen” vaginally implanted mesh that was recalled from the market more than ten years ago due to similar vaginal wall erosion issues. In light of the ProteGen problems from more than ten years ago, the vaginal mesh implant companies should never have sold their products in the first place and the FDA should not have approved them for sale.
Who might have a claim?
Although everyone implanted with a synthetic transvaginal mesh may have a theoretical legal claim, claims without specific damages are disfavored by courts and are typically not worth the expense and emotional burden of pursuing litigation. At our firm, we screen for cases in which the patient suffered either:
- Diagnosed organ damage due to adhesions to the bladder or urethra, or due to perforations of the bowel. Interstitial cystitis and fistulas are common terms used by physicians. Sometimes organ damage can be diagnosed if the patient had to be hospitalized after their mesh, tape or sling was implanted. Often, if organ damage has occurred, the patient’s treating doctor will recommend mesh removal, replacement or repair surgery, and sometimes tissue reconstruction surgery.
- Ongoing severe symptoms such as:
- the mesh eroding or sticking through the bladder, bowel or vagina,
- unexplained infection or recurring infections,
- pain during intercourse (“dyspareunia”)
- vaginal scarring, or erosion or sloughing of vaginal tissue,
- recurrence of vaginal prolapse, uterine prolapse, or,
- urinary problems like incontinence.
Read more about vaginal mesh erosion symptoms.
We then screen to determine if medical malpractice may have been the cause of the problems. Indeed, the vaginal mesh manufacturers have already started defending these mesh lawsuits, much as they defended the earlier bladder sling cases, by blaming the patient’s physicians and surgeons. Sometimes, though, the problem really was primarily due to medical malpractice, and so we independently investigate the issue.
We look initially for when the problems began: if the patient had unexpected problems (like trouble urinating) within the first month of the implant, it is more likely the problems were caused by malpractice than by mesh erosion. If, instead, the problems began six months or later after the implant, then it makes it more likely that the mesh was the problem, not a negligent surgical installation. If the injuries appear to be caused by malpractice, then we will handle the case as a malpractice case rather than a defective medical device case.
If you fit the above criteria, or aren’t sure if you do, please use the form on the right to send me and email or call my office directly at (215) 948-2718 for a no-cost, confidential review of your claim.
Which mesh lawyers run this website?
I’m not a an actor on a television commercial or someone in a call center: I’m a real lawyer who has successfully tried serious injury and wrongful death cases in front of juries, and a four-time winner of the American Bar Association Journal’s award for legal writing. If you use the contact form below, the email goes to me. If you call (215) 948-2718, it will be answered by me or by my receptionist.
But I know the reality: drug companies rarely listen to individual lawyers. I am of counsel with TorHoerman Law, the nationwide product liability firm that negotiated the $2.4 billion Actos settlement and the $650 million Pradaxa settlement. We will bring to your case the same resources, perseverance, and exceptional legal representation.
What steps has the Food and Drug Administration taken?
On October 20, 2008, the FDA issued a Public Health Notification to healthcare practitioners alerting them to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), noting that the agency had received over 1,000 reports of complications arising from the use of transvaginal surgical mesh, and that the “most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”
On July 13, 2011 the FDA issued a Safety Communication update stating that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare,” and that a review of scientific literature had shown “showed that transvaginal public organ prolapse repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.”
Specifically, the FDA has identified the following common side effects of using surgical mesh to as an implant in the vaginal or pelvic region:
From 2008 to 2010, the most frequent complications reported to the FDA from the use of surgical mesh devices for POP repair included vaginal mesh erosion (also called exposure, extrusion or protrusion), pain (including painful sexual intercourse known as dyspareunia), infection, urinary problems, bleeding, and organ perforation. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. Many of the [medical device reports] cited the need for additional intervention, including medical or surgical treatment and hospitalization.
If a medical implant is effective at treating a condition, the FDA will permit some degree of complications, but the FDA’s latest data reveals both that (1) vaginal mesh implants are no better at treating public organ prolapse or stress urinary incontinence and (2) serious complications from the use of mesh are “not rare.” In fact, FDA data shows “approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery,” an extraordinarily high failure rate for a surgical implant.
On January 4, 2012, the FDA disclosed that it was “considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III,” which would heighten the requirements imposed on manufacturers before they can sell vaginal mesh. The FDA further ordered manufacturers of urogynecologic surgical mesh for POP and single-incision mini-slings for SUI to conduct near 100 new post-market studies to assess the safety of the meshes and the likelihood of severe complications developing.
On January 4, 2016, the FDA announced it was it was reclassifying a small subset of transvaginal meshes so that more clinical testing would be required before the devices could be sold. Unfortunately, the announcement is nowhere near enough to make these products safer or to get them off the market entirely, as I explained in this blog post.
Has there been a recall of transvaginal mesh?
Some consumer advocate organizations such as Public Citizen have called for the FDA to ban the marketing of synthetic surgical mesh for implantation in the vaginal wall. Physician organizations like the American Congress of Obstetricians and Gynecologists have not reached final conclusions as to whether the use of transvaginal mesh should be discontinued entirely.
Although the FDA has recognized the risks of vaginal mesh, such as mesh erosion, mesh contraction, and mesh shrinkage, and has questioned the usefulness of the synthetic meshes, the FDA has not yet ordered a recall of implanted meshes. It is unlikely that the companies which make these surgical meshes will voluntarily order a recall.
What scientific studies have been done to determine the safety of implanted vaginal mesh?
In addition to the extensive data reviewed by the FDA in reaching their conclusions, other studies have also found that transvaginal mesh to repair pelvic organ prolapse has a higher risk of serious complications. In Vaginal Mesh for Prolapse: A Randomized Controlled Trial, published in the medical journal Obstetrics & Gynecology in August 2010, the researchers concluded “At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.”
In Factors Associated With Erosion Of Transvaginally Placed Polypropylene Mesh For Pelvic Organ Prolapse, published in the medical journal Female Pelvic Medicine & Reconstructive Surgery, researchers found no data linking smoking, age, menopausal status, hormone replacement therapy, diabetes or body-mass index to be risk factors for the development of mesh erosion.
Is there a class action lawsuit against the makers of vaginal surgical mesh?
There are many individual pending lawsuits relating to vaginal mesh, but no pending class action lawsuits. Class action lawsuits are rarely used in personal injury and defective medical device cases. Instead, many individual cases are filed, and sometimes the court consolidates the pre-trial proceedings for those cases. We don’t file any of our cases as class actions; they’re individually filed, and they can only be settled with the client’s consent.
Patients who have suffered complications from the implantation of vaginal mesh to treat pelvic organ prolapse may be entitled to compensation if the manufacturers of transvaginal mesh are found to have been negligent in the design, testing, manufacturing and marketing of their products. I’ve previously written articles on this blogs about the types of claims available against pharmaceutical and medical device manufacturers, like “failure to warn.”
Some cases have been settled on a confidential basis. American Medical System and C.R. Bard have both publicly disclosed settlements. Ethicon (owned by Johnson & Johnson) has steadfastly refused to settle, and our firm is currently pursuing several “bellwhether” cases against them.
How did this happen?
Highly similar surgical meshes have been used by surgeons to repair hernias and other abdominal issues, and so the FDA allowed the use of those meshes for pelvic repairs, including when implanted into the vaginal wall, without first requiring controlled human studies. This loophole — called the “510(k) clearance” — has been sharply criticized by the Institute of Medicine, which has recommended eliminating the “510 (k) clearance” program entirely.
Those studies would have likely revealed the problem before the surgical meshes were implanted in over 70,000 pelvic and vaginal wall procedures a year. Further, as described above, the current vaginal mesh erosion problems are substantially similar to complications noted in a pelvic mesh recalled from the market more than ten years ago, and so the FDA should not have approved any of the current meshes in the first place. The manufacturers of these meshes, however, had a legal duty independent of the FDA to ensure their products were properly designed, tested, and manufactured, and it appears the manufactures did not fulfill their legal and ethical duties to their patients.
What is pelvic organ prolapse?
Pelvic organ prolapse is a condition in which the bladder, rectum, small bowel or urethra drop lower in the abdomen, typically as the result of weakness in the muscles and connective tissue of the vaginal wall caused by child birth, a hysterectomy, or menopause. The additional pressure on the vagina can then cause pain (often described as a felling of pressure) and can cause urinary symptoms like incontinence, bowel symptoms like constipation, and sexual problems like pain during intercourse. Each of these conditions — bladder prolapse (cystocele), rectal prolapse (rectocele), herniated small bowel (enterocele), and uterine prolapse — causes distinct symptoms and is treated with separate methods, but the conditions share much in common and so are often discussed together.
Half of all women who give birth develop a prolapse, but most prolapses can be treated or kept from progressing with lifestyle changes (like quitting smoking), the use of Kegel exercises, or the insertion of a vaginal pessary, a small device similar to a diaphragm or cervical cap. 10% of women who develop prolapses need surgical treatment.
The FDA warnings currently relate only to the use of vaginal mesh to treat pelvic organ prolapse. Transvaginal mesh is also used to treat Stress Urinary Incontinence and in that capacity can also lead to similar complications; more general information about surgery to treat SUI is available here.
For a free, confidential review of your claim, use the contact form below or call my office directly at (215) 948-2718.