For women suffering from pelvic organ prolapse, pelvic mesh seemed like a miracle cure. Unfortunately, the lack of clinical testing of pelvic mesh products led to massive recalls and lawsuits after women began experience debilitating and permanent injuries. Transvaginal mesh injuries are the same types of injuries suffered by hernia mesh patients, which should come as no surprise considering both products are made out of the same material. This has left many hernia mesh victims wondering why manufacturers didn’t take the hint.

For women who have given birth or patients who have undergone surgery, the pelvic muscles can stretch and weaken causing organs like the bladder to sink lower in the body than normal. This is called pelvic organ prolapse and in the late 1990s, the first pelvic mesh was developed to treat the condition. Pelvic mesh is made out of polypropylene plastic, a material that is cheap to produce and abundantly available. Polypropylene plastic is also preferred because it is not biodegradable and it will not absorb into human tissues.

Three years after hitting the market, pelvic mesh products were subject to recalls. However, the original approval allowed other pelvic mesh devices to be approved through the controversial 501(k) approval process. The U.S. Food and Drug Administration (FDA), allows medical devices and prescription drugs to go through a much less stringent approval process if the device or drug is similar to one currently approved by the FDA.

Even though the first pelvic mesh product was eventually recalled, its approval allowed for the eventual approval of nearly sixty more pelvic mesh products. None of these devices were ever subject to clinical studies to prove their safety and efficacy. As a result, patients were unaware of the dangers associated with pelvic mesh, including bleeding, erosion of the device, the abnormal connection of two organs or tissues, nerve damage around the mesh, and migration of the mesh. Now thousands of woman are suffering from mesh erosion, vaginal scarring, urinary incontinence, painful intercourse, injury to the bladder, and other debilitating injuries.

Pelvic organ prolapse and hernias were once thought to be very similar conditions, so manufacturers designed hernia mesh based on pelvic mesh devices. Hernia mesh products produced a similar history when the FDA began recalling hernia mesh devices for causing complications. However, through the 501(k) approval process, dozens of hernia mesh manufacturers flooded the market. Because it is made out of the same material as pelvic mesh, hernia mesh has produced similar complications, including producing scarring, inflammation, bleeding, nerve damage, migration, and the connection of two organs.

All patients deserve to know the risks associated with medical devices and procedures. Both pelvic mesh and hernia mesh patients were not warned of the dangers, even after polypropylene plastic mesh products proved to be dangerous. The dangers of this type of mesh have been well known by manufacturers for over ten years, but to preserve profits, manufactures did not warn patients.

When the U.S. Food and Drug Administration (FDA) sent out a warning letter to patients and physicians in 2015 regarding infections from the Stockert 3T heater-cooler device, it was thought the full scope of the risk was understood. However, nearly two years later a new study has found the infection risk was more widespread than previously believed.

The Initial Problem

The Stockert 3T is manufactured in Germany by LivaNova. In early 2015, the company began to receive complaints from European patients about infections connected to the device. The heater-cooler device has been linked to rare bacteria called mycobacterium chimaera, or M. chimaera.

Studying The Infection Risk

Researchers from Pittsburgh looked into the infection risk presented by the Stockert 3T by collecting samples from across the country. Researchers tested 89 samples from 23 difference states, the District of Columbia, and Canada and found 33 units were contaminated with M. chimaera. The Stockert 3T is used in approximately 60% of hospitals for regulating patient body temperatures during cardiac/thoracic surgery, so the threat to patients is very real.

M. chimaera is a particularly dangerous bacteria because it presents very generic symptoms, making it difficult to diagnose. Last year, the FDA reported 79 instances of patient infections from the device, including at least 12 deaths. However, the agency believes many cases go unreported.

Infection Risk In Children

Recently, children who underwent cardiothoracic surgery in which the Stockert 3T was used have developed life-threatening infections because of the device.

Nearly one dozen children were infected with mycobacterium abscessus, or M. abscessus, a fast growing bacteria resistant to many types of antibiotics after undergoing surgery at the Children’s Hospital in New Orleans. M. abscessus can cause skin to become red, tender to the touch, swollen, or even painful. Infected skin can also develop boils. M. abscessus can also cause fever, chills, and muscle aches, among other symptoms.

Unfortunately, the Children’s Hospital in New Orleans is concerned there could be even more patients infected. Bacteria spread into open surgical wounds can lay dormant for months or even years before manifesting symptoms.

M. abscessus is most commonly spread in a hospital setting by contaminated medical equipment. Invasive procedures using contaminated medical equipment can expose a patient’s open surgical wound to the bacteria.

Informing Patients

After the latest findings from researchers, some hospitals are reaching out to patients to inform them they may have been exposed to the risk. Because it can take months or even years for infection symptoms to manifest, it is incredibly important for cardiac surgery patients to watch out for signs of an infection. If you underwent cardiac or thoracic surgery within the last five years, talk to your doctor about your infection risk.