Transvaginal mesh (TVM) implants are medical devices approved to treat pelvic organ prolapse (POP), a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls. Mounting litigation and growing adverse health reports question the devices’ safety and efficacy; many question if TVM devices pose more risks than benefits.
TVM has been associated with very serious reactions and not all are physical. In an ongoing case against Ethicon, a psychiatrist testified after evaluating the plaintiff, saying that the plaintiff’s and her husband’s lives are consumed with the pain that has taken over her life following implantation with a TVM, said Mesh Medical Device News Desk (MDND).
Prior to surgery in which she was implanted with the Prolift TVM, the doctor determined that the patient was a “dynamic woman” who loved her job, according to MDND. The plaintiff’s family—which also includes three sons and young grandchildren—is critical to her, said the doctor, as was her prior outdoor life. “She opted to have surgery so she could improve her quality of life,” the physician testified.
The woman received the Ethicon Prolift transvaginal mesh in July 2006 and claims the defective medial device has led to permanent physical and psychological damage. Previously, she had no history of depression, said MDND.
The plaintiff underwent a hysterectomy in 2001 which was followed by severe bleeding, stress incontinence, and other complications, said MDND. Following implantation with the TVM, the pain would increase and subside, becoming increasingly intense and then permanent, and leading to depression, anxiety, and feelings of hopelessness, the psychiatrist said. She can only sleep with medication, and then only for a few hours; she had to reduce her work hours; gained wait; has withdrawn socially; feels guilty; is unable to maintain her household; cannot play with her grandchildren; and is unable to be intimate with her husband, the psychiatrist said, according to MDND. She has also suffered through 55 medical procedures and some have led to other complications.
As we’ve previously written, the U.S. Food and Drug Administration (FDA) has warned that complications associated with TVM implants are “not rare.” The agency also stated that no clear evidence exists that TVM is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post market studies evaluating the dangers of TVM. According to an agency Safety Communication issued last summer, the most common reported adverse events related to transvaginal mesh include:
- Mesh erosion through the vagina (exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyapareunia)
- Organ perforation
- Urinary problems
Last June, Ethicon announced it would no longer sell four types of TVM devices, including the Prolift + M™ , TVT Secur, Prolift, and Prosima.
Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety. The devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.
As we’ve explained, thousands of women were recipients of TVM devices, which have come under increased scrutiny since many recipients of these devices began experiencing complications related to their defects, including severe pain, erosion of the devices through the skin or tissue, serious infections, and the need for constant revision surgeries to either correct or remove the devices. TVM allegedly has a risk of erosion, in which it travels through the body’s tissues. In some cases, the device can become embedded in inappropriate areas and multiple surgeries are required to remove it. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed.