Transvaginal Mesh FINALLY Pulled from Market
On April 15, The FDA ordered the only two remaining manufacturers of mesh used for transvaginal repair of pelvic organ prolapse to stop selling the products in the U.S. Unfortunately, this is too little too late for thousands of women injured by the mesh. Litigation over pelvic mesh is one of the largest mass tort cases in history. More than 100,000 women have filed suit due to injuries including bleeding, pain, inflammation, pain during sex, and perforation of organs. Many women have had multiple surgeries to attempt to remove the mesh but continue to suffer ongoing symptoms and complications.
For years women and legal advocates have tried to persuade the FDA to do something about pelvic mesh. In 2016 The FDA reclassified the mesh as high risk which would require the manufacturers to submit applications to gain premarket approval to continue marketing them in the U.S. All but two mesh manufacturers declined to do this and withdrew their products from the market in 2018. Boston Scientific and Coloplast filed applications for their devices but the FDA found that they had not demonstrated a reasonable assurance of safety and effectiveness for the devices (source: showardlaw.com).
SIDE-EFFECTS AND ADVERSE EVENTS LINKED TO TRANSVAGINAL MESH AND VAGINAL SLING PRODUCTS
Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from 7 surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:
- erosion through the vaginal tissue
- mesh contraction
- mesh extrusion
- infection and abscess
- blood loss
- chronic and acute nerve damage
- pudendal nerve damage
- pelvic floor damage
- scar tissue
- chronic pelvic pain
- urinary problems and/or incontinence
- recurrence of prolapse
- bowel, bladder, and blood vessel perforation
- dyspareunia or pain during sexual intercourse
The injuries that women are alleged to have suffered from this mesh implant are severe and debilitating and could have been avoided had people had the proper information.
The edges of the mesh/sling can cut through the skin after implantation, causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel, and uterus.
Complications from these infections can include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc. Some of these infections can spread through the whole body and lead to death.
Releases & Articles
April 1, 2016: FDA Release on Boston Scientific Urogynecologic Mesh:
Boston Scientific Surgical Mesh May Contain Counterfeit Raw Material
January 15, 2016: Transvaginal Mesh is the Stuff of Nightmares
"...surgical Mesh to be reclassified as class III or high risk medical device...", may be off the market by 2019 Read More in the Daily Beast
April 24, 2015: Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study
Study Shows that despite multiple FDA warning use of Transvaginal Mesh increased by 44.7%
July 13, 2011: FDA Safety Communication:
UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
https://www.meshmedicaldevicenewsdesk.com/mesigian-prolift-pelvic-mesh-trial-underway-in-philadelphia/ https://www.fiercebiotech.com/medtech/philadelphia-juries-knock-j-j-two-multimillion-dollar-verdicts-vaginal-mesh-cases https://www.beasleyallen.com/news/jj-hit-with-80-million-verdict-in-latest-vaginal-mesh-trial/ https://www.inquirer.com/business/pelvic-mesh-verdict-80-million-johnson-and-johnson-media-woman-20190517.html