The US Food and Drug Administration ordered two medical device companies to stop selling surgical mesh used to repair pelvic organ prolapse and stress urinary incontinence.
The action is somewhat of a breakthrough for those who have greatly suffered from mesh failure. According to the FDA, both Boston Scientific and Coloplast did not demonstrate a “reasonable assurance of safety and effectiveness” for their devices. This is considered a premarket standard that has been in effect since 2016, when the FDA reclassified surgical mesh from a Class II to a Class III (high risk).
Surgical mesh, often known as vaginal mesh, has been used in millions of women. Those who suffer from pelvic organ prolapse (POP) or stress urinary incontinence (SUI) may experience their bladder, uterus or other organs ‘sagging’ into their vaginal area. This can cause unpredictable bodily functions that are rather embarrassing.
The remedy with surgical mesh is intended to strengthen weakened pelvic muscles, allowing for organs to stay in place. Surgical mesh has not only worsened the problem– it has gravely affected the patients quality of life with worsening complications.
Flaws in surgical mesh design have caused an onset of painful symptoms such as:
- Localized or general pain
- Scar-like tissue that sticks tissues together (adhesion)
- Blockage of the intestines
- Abnormal connection between organs
- Organ perforation
- Allergic reaction
- Body rejection
- Mesh migration or erosion
- Mesh shrinkage (contraction)
- Fluid build-up at the surgical site (seroma)
Many woman have filed transvaginal mesh lawsuits against various manufacturers due to medical device failure. Not only have they experienced vaginal mesh complications, many have also had to undergo revision surgery.
FDA Reclassification of Surgical Mesh
The FDA implemented a premarket approval (PMA) system for all surgical mesh in a 2016 reclassification. That meant manufacturers were required to submit and obtain approval applications in order to keep their devices on the market. According to the announcement, both Boston Scientific and Coloplast “have not demonstrated a reasonable assurance of safety and effectiveness for these devices..”
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The companies were given 10 days to submit their withdrawal plan from the market to the FDA.
Boston Scientific and Coloplast filed PMAs for its devices, while the FDA asked an advisory panel to give input on the safety and effectiveness of surgical mesh for transvaginal repair for POP. The recommendations included the device post-surgery should be comparable to native tissue repair at 36 months. Both companies failed to provide such data, which is when the FDA decided not to allow them on the market any longer.
Women who were scheduled to have POP or SUI surgery with transvaginal mesh should consult with their doctor about alternative mesh. Those who already had surgery with either Boston Scientific or Coloplast mesh devices, and are not experiencing any discomfort, should continue with regular care.
Transvaginal or Hernia Mesh Brands
Transvaginal mesh isn’t the only surgical mesh device that has failed and caused tremendous pain and discomfort to patients. Both men and women have had their quality of life gravely affected by defective hernia mesh products. Hernia mesh has been linked to serious and often life-threatening complications after implantation.
The following is a list of hernia mesh products and manufacturers our law firm is currently accepting new cases on:
- Covidien Hernia Mesh
(including the following):
Plug and Patch, Composite (PCO), ProGrip Mesh
- Physiomesh Flexible Composite Mesh
- Gore Medical
- *Bard / Davol
- Composix EX
- Spermatex IP
- 3D Max
- Perfix Plug, PerFix Mesh
- Ventralex, Ventralex ST
- Composix Kugel
- Ventrio ST
- C-QUR Mesh, Edge Mesh V-Patch, Lite Mesh V-Patch, OVT Mesh, RPM Mesh, TacShield, V-Patch, Mosaic
Mesh Withdrawal in Europe
Earlier this year, C.R. Bard, a subsidiary of Becton Dickinson & Co., announced it would be withdrawing its surgical mesh used for POP and SUI from the European market. Though the company emphasized it was not a recall, many skeptics believe the withdrawal is due to public awareness about mesh failure.
Questions About a Transvaginal Mesh Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
Many women across the country have suffered surgical mesh complications, you are not alone. If you or a loved one are experiencing transvaginal mesh complications, you may want to speak with the lawyers at Johnson//Becker. We are currently pursuing transvaginal mesh lawsuits across the country, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
We would be honored to speak with you and respond promptly to every inquiry we receive.