As supported by the July 2011 U.S. Food and Drug Administration (FDA) warning, transvaginal surgical mesh implants used to repair pelvic organ prolapse (POP) have unnecessarily exposed thousands of women to significant and undisclosed risks of serious injury. Most of these transvaginal mesh side effects can lead to severe and emergency situations, requiring:
- Medical intervention
- Surgical treatment
- Hospitalization
In many cases, the mesh cannot be completely removed, and it, therefore, permanently compromises the health of the woman affected. If you needed further treatment because an implant used to treat your POP failed and caused you unnecessary pain and suffering, talk with our seasoned transvaginal mesh implants lawsuit lawyers today.
Our attorneys understand that not only do the women affected experience extreme pain, but entire families suffer as well. Women affected by transvaginal mesh may no longer be able to work or bring the same level of income as before, and they may be prevented from providing necessary household support due to their injuries.
FDA Warning Regarding Transvaginal Mesh Implants
The FDA voiced their concern in a warning issued on July 13, 2011, that the device does not provide the best solution to POP or Stress Urinary Incontinence.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant—complete removal may not be possible and may not result in complete resolution of complications.”
What Can Cause Pelvic Organ Prolapse (POP)?
If the walls of the vagina weaken after childbirth, internal support for many of the pelvic organs, including the bladder, rectum, or uterus, may be eliminated. Without this support, the organs can prolapse, or “drop,” causing women both discomfort and pain.
A prolapse of these organs can happen after a woman undergoes a hysterectomy because the removal of the uterus can also lead to a lack of support for the pelvic organs. Transvaginal mesh implants were created as a way to permanently provide extra support to these organs. The implants are also used to treat Stress Urinary Incontinence.
Consult With Us About Your Potential Transvaginal Mesh Claim
Although the FDA is now asking medical professionals to advise patients about these dangerous implants, there are women whose lives have been severely impacted prior to this warning and without knowledge of the hazards to their health. Our firm has been heavily involved in this litigation regarding transvaginal mesh implants and other defective medical devices.
We are knowledgeable and aggressive in gaining the compensation owed to victims who have been affected by defective products and corporate negligence. Talk with our transvaginal mesh attorneys today about the injuries you have sustained by calling our firm now.