The U.S. Food and Drug Administration (FDA) first approved transvaginal mesh for surgical use in 1996 as a minimally invasive treatment option for women suffering from pelvic floor disorders, like pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In the years since, it’s become an increasingly common procedure.
However, as more women underwent the procedure, reports of serious complications began to surface. Alleging grievous injuries, like chronic pain, nerve damage and infection, thousands of women have since decided to take mesh manufacturers, like Boston Scientific, to court seeking damages for their faulty implants. Today, Boston Scientific is one of six major manufacturers that have been named in lawsuits filed by more than 70,000 women injured by surgical mesh implants.
For those considering a transvaginal mesh implant today, there are a few crucial facts to consider.
1. Most surgical mesh implants have not undergone clinical trials.
Although there are roughly 60 different pelvic meshes currently available on the market, dozens of these devices have skirted clinical scrutiny thanks to a FDA 510(k) clearance process. Relying on the ProteGen sling as a predicate device, the 510(k) clearance process did not and does not require mesh manufacturers to submit their surgical implants for clinical trials. This is problematic on two counts: first, it means that a large proportion of pelvic meshes have never undergone meaningful clinical review. Second, the ProteGen sling was itself recalled in 1999 due to safety reasons. This means that some meshes, which have bypassed safety review, continue to be implanted into patients based precisely on their similarity to a recalled product, the ProtoGen sling.
2. There is a high complication rate.
Transvaginal mesh is marketed as a less invasive alternative to procedures like colporrhaphy, yet, according to a 2011 study, complication rates were significantly higher among transvaginal mesh than colporrhaphy patients. The study also found that transvaginal mesh patients were more likely to experience longer operating times, greater intraoperative blood loss and more bladder perforations as a result of the surgery.
3. Some transvaginal mesh is made of counterfeit materials.
Earlier this year, the FDA issued a safety warning acknowledging that Boston Scientific’s transvaginal mesh “may” contain counterfeit materials. Specifically, Boston Scientific is accused of using an unapproved Chinese polypropylene, a polymer plastic, in the production of its meshes.
As a result of these allegations, Boston Scientific is currently the target of a Racketeering Influenced and Corruption Organization (RICO) lawsuit brought by Mostyn Law alleging a slew of illegal activities in relation to its transvaginal mesh business, including fraud, intentional misrepresentation, and negligent misrepresentation, violations of West Virginia’s trade or consumer practices, and unjust enrichment. RICO actions are typically used to target criminal enterprises like the Hell’s Angels and organized crime families. The lawsuit seeks both civil sanctions and criminal penalties against Boston Scientific.
4. Revision surgery is difficult.
Patients are often told that if they experience complications, a surgeon can simply remove the mesh implant. In reality, many meshes are designed as permanent implants and removing them is a complex and painful procedure that requires a highly skilled surgeon. Despite the complications that revision surgery presents, it is nevertheless on the rise due to the influx of women coming forward with faulty mesh implants.
5. There are alternatives to mesh
A number of alternative treatment options are available for POP and SUI patients. These include pelvic floor therapy, as well as surgery that utilizes the patient’s own tissue to support organs in place of mesh. Plastic devices called pessaries are also available and recommended for women who intend to conceive in the future.
If you are debating whether to get a transvaginal mesh implanted, talk with your doctor about the risks and alternatives. Ask questions so that you are fully informed about the potential complications. Weigh the risks of vaginal mesh against your current symptoms so you can decide what course is best for you.