Newsletter - January 2015

Transvaginal Mesh Litigation

Boston Scientific Corp. (henceforth "Defendant"), a developer & manufacturer of medical devices, in November 2014, was ordered to pay four women over $26 million after a Miami federal court jury found that it was liable for marketing faulty Transvaginal mesh devices.

According to Thompson Reuters, the Plaintiffs sustained bleeding, pain, and infection as a result of the company's Pinnacle device, which was developed to treat pelvic organ prolapse and stress urinary incontinence. Although the Defendant was ordered to pay $26.7 million in compensatory damages, it will not face additional punitive damages. Each Plaintiff in the case is receiving between $6.5 million and $6.7 million.

The Defendant is currently facing beyond 14,000 federal lawsuits over its mesh devices.

In the last 3 months, Neural IT's Voice Processing division has been highly successful in converting leads for clients. Out of 1,361 possible contacts, the Voice Processing team was able to convert 30.5% or 416 contacts.

In the Transvaginal Mesh litigation space, Neural IT has had 1,630 medical record requests from firms, out of which 860 were reviewed for evidence. Of those records, our physicians found evidence in 453 that identified the product used in a given case, for a conversation rate of 52.67%.

Pelvic organ prolapse (POP) is an often frustrating condition that many women experience after childbirth and with changes linked to menopause, obesity, persistent cough or constipation that strains your muscles, and other common issues.

It’s caused due to the weakening of the pelvic floor muscles that normally hold your uterus, urinary bladder, and other pelvic organs in place. As these muscles stretch and weaken, your pelvic organs can begin to droop (prolapse) out of place. Though not typically life-threatening, pelvic organ prolapse can cause severe urinary incontinence (unexpected loss of urine), painful sexual intercourse, fecal incontinence (loss of stool), and other life-altering issues.

Depending on the extent of the prolapse, doctors may recommend transvaginal (vaginal) mesh surgery to help resolve your symptoms. The mesh is a surgical material that is implanted during the procedure and designed to reinforce the vaginal walls and supply support for your bladder and urethra. Transvaginal refers to the surgical approach (through the vagina) and may be suggested because it’s minimally invasive and eliminates the need for external incisions. 

Complications associated with vaginal mesh surgery include vaginal scarring, perforation of nearby organs, urinary problems, and return of pelvic organ prolapse. While the symptoms associated with vaginal mesh complication include painful sexual intercourse, which the women's partner may also experience due to encountering loosening vaginal mesh material, bleeding of the vagina that isn’t related to the menstrual cycle, persistent pelvic pain, and abdominal discharge of the vagina. 

There are also non-surgical ways to treat POP like pelvic floor physiotherapy where the pelvic muscle can be strengthened by regularly performing glute bridge exercise which has to be performed perfectly under the supervision of a physiotherapist. Other ways are bladder training and vaginal pessary where a ring-like device is placed in the vagina that helps support the pelvic organs reduce descent. Apart from this, lifestyle changes like eating healthy foods, maintaining a good weight, and avoid heavy lifting can also help overcome POP problems.

Vaginal mesh implants were introduced in the late 1990s as a routine treatment for stress urinary incontinence and pelvic organ prolapse, common complications following childbirth. However, these flexible plastic scaffolds have led to life-altering complications for many women including nerve damage, chronic pain, and several reported deaths. Medical Technology looks over the story of vaginal mesh, from the 90s to the present day.

Thousands of women who received transvaginal mesh implants to treat conditions called pelvic organ prolapse and stress urinary incontinence say that they suffered severe pain, organ damage, and other complications because of the devices. 
Since 2012, women who have sued companies over transvaginal mesh have won at least 20 verdicts in state and federal courts totaling around $300 million. By March 2017, multiple companies had settled thousands of claims for millions.

Some patients have won multimillion-dollar verdicts against manufacturers. One jury, for example, awarded $68 million to Mary McGinnis and her husband in 2018. Another jury awarded Patricia Mesigian $80 million in 2019.

A total of 108,008 lawsuits have been filed in the MDLs. But waves of settlements have whittled down the number of lawsuits that are still pending.

Before the Judicial Panel on Multidistrict Litigation formed the main mesh MDL in West Virginia, the first transvaginal mesh lawsuits involved a device called ObTape manufactured by Mentor. In 2008, the judicial panel combined several of these cases into multidistrict litigation.

Women who received the device for prolapse or stress urinary incontinence, also called SUI have filed lawsuits saying that they have suffered from painful injuries.

These women had problems such as sitting, walking, having sex, and participating in other activities, according to lawsuits. The complications were so bad that many women had to suffer through multiple revision surgeries to remove the implants.

Juries have sided with numerous plaintiffs who accused companies of designing defective products, fraudulently promoting the safety of the devices, and failing to warn of potential complications. Despite multiple settlements, thousands of lawsuits are still pending in federal and state courts. It’s unclear whether companies will try to resolve remaining claims or fight them. 

Johnson & Johnson lost the first federal mesh lawsuit in February 2013, and American Medical Systems became the first company to agree to a large settlement in July 2013. Less than a month later, Bard lost the second federal lawsuit involving transvaginal mesh.

Five companies began settlement discussions in October 2013. Johnson & Johnson was the only company that did not participate. It remains the company with the most lawsuits pending against it.

Transvaginal mesh products are sometimes used to repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions that can often occur following childbirth or as patient ages. Despite how commonplace the use of mesh products in these procedures became following their introduction, both in the US market and globally, patients soon began to experience severe, devastating complications.

Complications from mesh include nerve damage and chronic pain, vaginal scarring and shrinkage resulting from the erosion of the mesh inside of the body, and cases of organ perforation where the implants became exposed inside the patient’s vaginas. The implants have even been linked to several deaths.

Researchers have struggled to determine how often these issues occur, current estimates lie between 15% and 25%. What is clear is that when complications do arise they are often severe and life-limiting, far more so than the original condition they were intended to treat.

Transvaginal mesh products are sometimes used to repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions that can often occur following childbirth or as patient ages. Despite how commonplace the use of mesh products in these procedures became following their introduction, both in the US market and globally, patients soon began to experience severe, devastating complications. 
  
The US Food and Drug Administration (FDA) cleared the first mesh implant for SUI, Boston Scientific’s ProteGen Sling, in 1996. The first mesh for pelvic organ prolapse (POP) was approved in 2002. 
In 2008, the FDA released a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed transvaginally to treat SUI and POP.

A later safety communication was issued about the use of mesh specifically for POP in 2011. The FDA noted that serious complications associated with these procedures were not rare, and that mesh surgeries did not alleviate patients’ symptoms any more than non-mesh procedures.

News

Jul 26, 2018

Just a week after the United Kingdom's National Health Services (NHS) declared a temporary ban on the use of transvaginal mesh, Ireland's Chief Medical Officer Simon Harris has also announced a temporary suspension on the use of the mesh stating “understandable public and patient anxiety” concerning the safety of the implants.

Harris stated, "there are understandable public and patient anxiety about the ongoing safety of mesh devices following the considerable publicity that this issue has received, and this has been heightened by recent developments in the NHS. A pause on the use of mesh procedures, pending confirmation by the Executive that the key recommendations below have been implemented, is now considered proportionate and necessary to provide public assurance that these procedures are being carried out in accordance with internationally accepted good practice.” The ban will remain intact till Ireland's Health Service Executive (HSE) can provide possible recommendations related to surgical training, informed consent and an agreed dataset development on the mesh products.

Lawsuits against the manufacturers of Transvaginal mesh (TVM) continue to be filed in the U.S. District Courts, over design flaws causing severe internal injuries in several women. Ethicon, C.R. Bard, Boston Scientific are some of the defendants in the TVM litigation, overlooked by Judge Joseph R. Goodwin in the Southern District of West Virginia.

Jan 4, 2018

The FDA has shown no signs or indications regarding any ban on transvaginal mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) with the news pouring in about a recommended ban requested by the National Institute for Health and Care Excellence (NICE) in the U.K.

NICE requested the ban indicated for the treatment of POP and not SUI and expects a virtual ban as the news spreads.

Although thousands of transvaginal lawsuits have been filed in the U.S. since 2008, with mixed verdicts announced for both parties, and manufacturers settling a significant number of claims, the FDA has no intention of considering a ban. The agency did reclassify the device in 2016 as a Class III (high risk) product for the treatment of POP, making them ineligible for the 510(k) clearance program.

Aug 8, 2017

Another Transvaginal Mesh manufacturer, Endo International plc (Endo), announced this August that it was setting aside an additional $775 million rounding off to a near total of $2.6 billion to resolve the remaining 22,000 Transvaginal Mesh Multidistrict Litigation lawsuits pending in the US District Court of West Virginia. This amount was in addition to the millions the company had spent earlier to settle the cases.

TVM litigation cases are one of the largest mass torts. As of now, thousands of mesh lawsuits are consolidated in West Virginia federal court through seven multidistrict litigation (MDL) cases and the remaining are filed in the state courts in Pennsylvania and West Virginia.