Women may experience stress urinary incontinence or pelvic organ prolapse (POP) as a result of pelvic muscles and tissues weakening from childbirth, menopause, or surgeries. A pelvic organ prolapse (POP) occurs when the pelvic muscles are no longer able to support pelvic organs like the bladder, urethra, and bladder. One or more of these organs may then fall or drop forward into the vaginal wall. Severe forms of POP may be treated with surgery. Vaginal meshes were hailed as an improved solution to traditional non-mesh surgery because they reduce the risk of recurrence. Unfortunately, they also cause more post-treatment complications and side effects.
Each year, thousands of women have corrective surgery to repair POP. The U.S. Food and Drug Administration (FDA) has received a significant number of complaints that have resulted from the use of transvaginal mesh and vaginal slings. In July 2011, the FDA warned of increased risk of serious and painful complications associated with transvaginal surgical meshes.
Identified Problems with Surgical or Pelvic Mesh Implants
Complications arising from transvaginal mesh implants include mesh failure, infection, vaginal pain, urinary problems, pelvic pain, erosion of the mesh into the vagina, hardening of the vaginal mesh, injury to nearby organs, and difficulty during sex. Additional side effects from the mesh implants may include bleeding and pain; erosion through vaginal epithelium; recurrence of prolapse and/or incontinence; bowel, bladder, and blood vessel perforation; and dyspareunia (pain during intercourse).
Manufacturers of Surgical or Pelvic Mesh Implants with Reported Problems
In 2008, the FDA warned about possible complications with vaginal mesh surgeries, but noted that these complications were rare. Then, between 2008 and 2010, the agency received five times as many reports of vaginal mesh problems as they had between 2005 and 2007. At the same time, new studies emerged highlighting the risks of complications, including mesh erosion into the vagina or other organs, scar tissue formation, infections, pelvic pain, urinary incontinence, and recurrence of prolapse.
The following is a list of vaginal mesh implant manufacturers whose products have reported problems:
Ethicon's Gynecare Prolift (Johnson & Johnson): Some patients have reported persistent or recurring pain caused by the Gynecare Prolift Pelvic Floor System. The most common complaint among Gynecare Prolift Pelvic Floor System patients is mesh erosion. When the Gynecare mesh is surgically inserted, the patient may suffer from trauma caused by bladder, bowel and blood vessel perforation. This trauma is believed to be the cause of vaginal mesh erosion. Patients also complain that the Gynecare complications cause pain before, during, or after sexual intercourse, otherwise known as dyspareunia. Patients also report the surgical insertion of the Gynecare Prolift has led to serious infection. Infection could be caused by bladder, bowel and blood vessel perforation. Also, the vaginal mesh may be blocking tissue from absorbing nutrients and oxygen, which impairs healing and eventually leads to infection. Infection can lead to death, which makes this the most serious of the Gynecare complications. As a result, these patients often have the Gynecare mesh surgically removed. In July 2011, the FDA issued an updated Gynecare mesh FDA warning stating that complications with vaginal mesh are not rare, and that it is unclear if POP repair with products like Gynecare Prolift is better than traditional non-mesh repair. The FDA warned physicians to be aware of the risks, and to tell their patients that some of the complications may not be reparable even with additional surgeries. The Gynecare Prolift is manufactured by Ethicon, a subsidiary of Johnson & Johnson. A multi-district Gynecare lawsuit is now underway, but injured parties must respond before their claims expire, the date of which depends on the brand of vaginal mesh used in their situation.
Pinnacle Pelvic Floor Repair Kit (Boston Scientific): A second brand of transvaginal mesh that has caused complications within patients is the Pinnacle Pelvic Floor Repair Kit, manufactured by Boston Scientific. This vaginal sling, made of polypropylene knitted mesh, is also known to erode and extrude within the body, causing pain and complications such as infection, urinary trouble, and dyspareunia. Despite the quick recovery time and the simplicity of the transvaginal mesh procedure, patients who receive the Pinnacle Pelvic Floor Repair Kit often report serious complications following the insertion. Boston Scientific warns that use of the device may require serious follow-up care, including apical repair for uterine enlargement, mesh removal/revision surgery, hysterectomy from tissue in-growth and scarring, and more. The Pinnacle Pelvic Floor Repair Kit is not the first of Boston Scientific’s vaginal slings to come under scrutiny for dangerous complications. Boston Scientific began manufacturing transvaginal mesh products in 1996, and in 2011, the FDA alerted the public to the complications of the “simple surgery.” Despite the continuing complications and distressed consumers, Pinnacle Pelvic Floor Repair Kits are inserted in – and removed from – thousands of patients every year.
Avaulta Plus (CR Bard Inc.): As of 2013, CR Bard Inc. is working to settle thousands of transvaginal mesh lawsuits across the nation. Patients who received the Avaulta Plus transvaginal surgical mesh report pain, infection, urinary trouble, and other complications similar to other transvaginal mesh products available. Like other products, the Avaulta Plus is made with polypropylene plastic that can erode or perforate the patient’s organs, causing dangerous infection and serious pain. This type of surgical mesh was created to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but has proven to cause more harm than good in many women. No recall has been issued for the Avaulta Plus or other transvaginal mesh products, despite more than 1,000 reports of complications associated with the devices.
American Medical Systems, Inc. (AMS) products: American Medical Systems, Inc. recently settled nearly 20,000 cases claiming that their transvaginal mesh medical devices caused serious side effects, including vaginal bleeding, chronic pain, infection, and vaginal scarring, and more in women across the country. Other serious side effects reported include mesh contraction, mesh erosion, the perforation of organs, and more. Like companies that produce similar devices, AMS markets their transvaginal mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but analysis has concluded that the risks and side effects involved with implanting device greatly outweigh the medical benefits.
Pelvic mesh products produced by AMS include:
Coloplast products: Coloplast Corporation is another brand facing thousands of claims across the nation that their transvaginal mesh devices cause severe side effects within patients. Like other pelvic mesh devices, inflammation, urinary dysfunction, painful sexual intercourse, and more side effects can result from the use of Coloplast products. Other serious side effects, such as mesh erosion, can begin to affect patients using these devices and require follow-up or revision surgery.
Additional manufacturers that the FDA has received reports regarding complications from transvaginal mesh implants or slings include: Caldera, Sofradium, Tyco, and Mentor Corporation.
Your Legal Options
Our defective medical device attorneys are currently evaluating cases concerning defective transvaginal mesh implants, including the Gynecare Prolift Pelvic Floor Repair System. If you or a loved one has received a Gynecare mesh implant, one of the implants listed above, or a failed pelvic mesh implant leading to pain or other complications, including revision surgery, please contact Brayton Purcell LLP today or call our toll-free number, 800-598-0314.