You know a device presents a serious danger when the FDA releases not one but two warnings about the potential pelvic mesh complications following a surgical procedure. These complications incited multiple FDA warnings and led to one of the largest lawsuits in medical history. The first warning about the complications for surgical mesh devices used to treat POP (pelvic organ prolapse) and SUI (stress urinary incontinence) was issued October 20, 2008, and the second was issued on July 13, 2011, with reports of severe complications and injuries continuing to file in to this day.
To underscore the severity of these warnings, you must first understand what transvaginal mesh implants are and why they can be dangerous. For those suffering from POP and SUI, daily activities can be difficult. Organs may be at risk, and the unintentional loss of urine (when sneezing, exercising, etc.) is just one among many uncomfortable symptoms. To repair the weakened vaginal wall, a net-like implant (transvaginal mesh) is inserted which prevents many common POP and SUI side effects. Unfortunately, inserting the mesh is not always necessary to address those issues and has caused an array of complications of its own. Furthermore, the FDA has reported that these pelvic mesh complications are not rare.
Included among the complications reported to the FDA following transvaginal mesh procedures are:
- Mesh erosion through the vagina
- Pain
- Infection
- Bleeding
- Pain during sexual intercourse
- Organ perforation
- Urinary problems
This list is in no way comprehensive of every transvaginal mesh surgery complication.
FDA Receives Thousands of Reports on Pelvic Mesh Complications
From 2005-2007, the FDA received over 1,000 adverse event reports involving transvaginal mesh surgery. And from 2008-2010, the FDA received an additional 2,874 reports. Included were accounts of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional damages. Most pelvic mesh complications required additional intervention including medication, surgeries to repair damage, and hospitalization.
If you had transvaginal mesh surgery, doctors suggest looking for the following symptoms. If you have any of these symptoms, report them to your physician immediately:
- Pain during intercourse
- Other types of chronic pain
- Fever or vaginal discharge that’s bloody or malodorous
- A recurrence of the prolapse
The FDA asserts that many complications are needless, since POP and SUI could be treated without invasive and problematic surgeries. They state that this type of procedure carries unique risks and benefits, and that it is important for health care providers to consider the necessity of such procedures before causing unnecessary suffering and complications to their patients.
If you or a loved one experienced complications following transvaginal mesh surgery, you may be entitled to compensation. Over 50,000 transvaginal mesh injury claims have been filed. if you were injured, get a free case evaluation today before the statute of limitations runs out.