Use of surgical mesh in pelvic surgery (also referred to as pelvic, transvaginal or urogynecologic mesh) has been linked to serious complications, including infection, chronic pain, urinary tract problems, mesh migration and rejection. These complications often require hospitalization and additional surgery. In rare cases, these complications may lead to death.
What Is Pelvic Mesh?
Pelvic mesh is a surgical implant used during pelvic surgery to provide additional support to weakened muscle and tissue of the pelvic floor.
Pelvic mesh is a screen-like device, made primarily of synthetic materials. Pelvic mesh products are manufactured by a number of companies, including Boston Scientific, Ethicon (a subsidiary of Johnson & Johnson), C.R. Bard, American Medical Systems (a subsidiary of Endo International), Coloplast and Covedien. Surgeons have used surgical mesh to treat various conditions since the 1970s, but the first mesh specifically designed for pelvic use (for the treatment of stress urinary incontinence (SUI)) was cleared by the FDA in 1996. A mesh specifically designed for pelvic organ prolapse (POP) was cleared in 2002.
Hundreds of thousands of surgeries to repair POP and SUI are performed every year in the United States, and pelvic mesh is now implanted during a large percentage of these surgeries. Pelvic mesh is generally designed to be a permanent implant, and within weeks the mesh becomes embedded in surrounding tissue.
The use of pelvic mesh has been linked to a high incidence of adverse health consequences and complications, some of which occur years after the original surgery. These health issues include:
- chronic pain
- adhesions (mesh adhering to an organ or scar-like tissue adhering two organs together)
- fistula (Abnormal connection between organs)
- nerve damage
- mesh migration
- mesh erosion
- mesh rejection
These are serious complications, often requiring hospitalization and additional surgery to correct the adverse impact on a patient’s health. If removal of the mesh is warranted, it necessitates a technically complex surgical procedure with risk of nerve and organ damage.
Not only are the complications associated with pelvic mesh significant, but recent studies suggest that the use of pelvic mesh fails to resolve the original condition in the majority of women in whom it is implanted. In one study, approximately 59% of the women surveyed reported that pelvic mesh did not resolve the symptoms for which they had originally sought treatment.
The FDA and its counterparts in other countries have issued numerous safety communications and alerts regarding the use of pelvic mesh products. In 2011, due to the high number of reports of complications, the FDA issued a communication titled “Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” in which it cautioned patients about the risks associated with pelvic mesh products, and recommended that surgeons “recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”
In 2016, the FDA reclassified pelvic mesh products used for POP repair from a moderate-risk device to a high-risk device.
In November 2017, after a thorough review and a Senate inquiry, Australia banned the use of pelvic mesh products for POP repair.
When Is Pelvic Mesh Used
The FDA has cleared pelvic mesh products for the treatment of two conditions, POP and SUI:
Pelvic Organ Prolapse
POP is a condition in which the pelvic floor muscles, ligaments or tissue are weakened, allowing pelvic organs, such as the bladder or uterus, to shift out of proper position.
Childbirth is the main cause of damage to pelvic floor muscles and ligaments, and up to half of women who have had children experience POP. Another significant cause of POP is the hormonal changes of menopause, which can also lead to weakened and less elastic muscles.
While some women experience no symptoms even though they suffer from POP, others experience significant and debilitating symptoms such as a feeling of heaviness or fullness in the pelvic area, painful intercourse, constipation, difficulty urinating, constant urge to urinate and vaginal spotting or bleeding.
Stress Urinary Incontinence
SUI refers to the unintentional leakage of urine due to physical movement or activity that puts stress on the bladder. In women experiencing SUI, unintentional leakage of urine may be triggered by sneezing, coughing, laughing, running or lifting heavy objects. SUI is a common condition – up to 50% of women experience bladder leakage occasionally, and approximately 20% of women report SUI as causing a significant problem in their daily lives.
Complications and Long-Term Risks from Pelvic Mesh Implantation
According to the FDA, complications associated with pelvic mesh implantation are not rare. Pelvic mesh products are known to be at risk of migration, erosion, rejection and adhesion formation. These complications may lead to severe health problems, including chronic pain, nerve damage and infection.
Complications may arise a month or longer after the surgical procedure. The FDA recommends that patients with pelvic mesh implants notify their health care providers if they experience persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during intercourse.
FDA Safety Warnings
Although the FDA has not banned the use of pelvic mesh products, it has raised significant concerns about their use.
- In October 2008, the FDA issued a Public Health Notification warning about complications associated with the use of surgical mesh to treat POP and SUI. The Notification stated that the FDA had received over 1,000 reports of complications, and that the “most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”
- In July 2011, the FDA issued a Safety Communication titled “Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” in which it stressed that serious complications associated with pelvic mesh products used for POP repair are not rare. In this Communication, the FDA recommended that health care providers choose mesh surgery only after considering several factors, including that “a mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.”
- As of Feb. 17, 2013, the FDA issued 109 postmarket study orders to dozens of manufacturers of pelvic mesh. This is unusual, because the FDA orders medical device manufacturers to conduct postmarket studies only in rare circumstances.
- In January 2016, the FDA issued an order reclassifying pelvic mesh used for POP repair from a moderate-risk (Class II) device to a high risk (Class III) device. In its explanation of the order, the FDA stated that it had seen “a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.”
The FDA is not alone in its concerns about pelvic mesh. Similar warnings have been issued by counterpart agencies in other countries, including Canada and Great Britain. And in November 2017, Australia banned the use of pelvic mesh for POP repair.
Numerous lawsuits have been filed in the United States against the manufacturers of pelvic mesh products, including Boston Scientific, Ethicon (Johnson & Johnson), C.R. Bard, and American Medical Systems (Endo International). These lawsuits seek compensation for complications and injuries associated with the implantation of pelvic mesh. In some instances these cases have resulted in either the award of significant monetary damages to the plaintiffs or in settlements that are highly favorable for the plaintiffs.
How We Can Help
If you have suffered serious health problems after pelvic surgery involving the use of pelvic mesh, you may be entitled to reimbursement for medical expenses, lost wages and other costs. Attorneys at Wilentz, Goldman & Spitzer P.A. may be able to help you recover compensation if you suffered serious harm from pelvic mesh. As a nationally recognized personal injury law firm and one of New Jersey’s largest law firms, Wilentz is committed to helping clients with their cases.
For a free consultation or more information about your legal options, please call the number below. Or, if you prefer to complete our free case evaluation form, our client relations representative will contact you shortly.