FDA Orders Complete and Total End to the Sale and Distribution of Pelvic Mesh

FDA Orders Complete and Total End to the Sale and Distribution of Pelvic Mesh

The Food and Drug Administration (FDA) has ordered an immediate halt to the sale and distribution of all surgical mesh products used to repair pelvic organ prolapse. Also known as pelvic or vaginal mesh, companies are already paying nearly $8 Billion to resolve claims associated with these dangerous medical devices.

Most manufacturers voluntarily stopped sales after the agency raised concerns about pelvic mesh in 2011. According to the FDA, Boston Scientific and Coloplast, the 2 remaining manufacturers of pelvic mesh, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” The devices in question were:

  • Uphold™ LITE Vaginal Support System (Boston Scientific)
  • Xenform™ Soft Tissue Repair System (Boston Scientific)
  • Restorelle® DirectFix Anterior (Coloplast)

More than 100,000 women have filed claims against manufacturers of pelvic mesh after suffering horrific injuries from a medical device that was supposed to help them. The implants have scarred and eroded inside women, requiring painful revision surgeries. As of last year, the FDA said it had received reports of 80 deaths.

For women who have pelvic mesh implanted, the FDA advises no additional action unless they are experiencing complications. Continue with routine check-ups, follow-up care, and be alert for symptoms, including:

  • persistent vaginal bleeding or discharge
  • pelvic or groin pain
  • pain with sex

Women who were planning to have pelvic mesh implanted should discuss other options with their physician.

Surgical Mesh and Pelvic Organ Prolapse

Surgical mesh is used during surgery to provide support when repairing weakened or damaged tissue. In women with POP (pelvic organ prolapse), the mesh was most often made of non-absorbable synthetic polypropylene, although its use declined as the risks of pelvic mesh were publicized.

Roughly 1 in 8 women will undergo surgery for POP during their life time. In women who have POP, the pelvic organs — the uterus, vagina, cervix, urethra, bladder, and rectum — begin to sag because the supporting muscles have weakened due to child birth, age, or other reasons. Symptoms of POP include:

  • Pelvic discomfort, pain, or pressure
  • Bulge of tissue or organs that protrudes to or past the vaginal opening
  • Leakage of urine (urinary incontinence)
  • Sexual difficulties

In order to reinforce the vaginal wall and keep organs in place, pelvic mesh was sometimes implanted in women with POP as part of their treatment. Vaginal mesh was also similarly used to treat stress urinary incontinence (SUI).

How the FDA Determined Pelvic Mesh Is Not Safe and Effective

The stop order on pelvic mesh is the latest in a string of regulatory actions taken by the FDA to address the thousands of women who have come forward with serious health issues as a result of pelvic mesh.

In 2011, the FDA issued a Safety Communication concerning pelvic mesh and ordered 34 manufacturers to conduct post-market surveillance studies of their products. Most manufacturers opted to stop marketing pelvic mesh instead of conducting the research.

In 2016, the FDA reclassified pelvic mesh as a Class III device. The new classification is the agency’s most stringent, and requires manufacturers to submit premarket approval applications in order to keep their device on the market.

In 2019, after reviewing the premarket approval applications of the 2 remaining manufacturers, the FDA decided that the devices did not meet he required standards.

“We determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”

Could Other Dangerous Medical Devices be Reclassified?

The reclassification of pelvic meshes and their subsequent prohibition is part of a deliberate push by the FDA to “advance women’s health and improve access to safe and effective medical devices.” For too long, the medical device market was governed by outdated regulations which put untested medical devices on the market. The results have been devastating.

Pelvic meshes are just one of an increasing number of medical devices that come with risks patients were never warned about. Worldwide, medical devices are linked to an estimated 1.7 million injuries and 83,000 deaths in the last decade. And when people start getting hurt or killed, it takes years for the FDA to recognize and respond to the problem.

No doubt the pressure of 100,000 pelvic mesh lawsuits had something to do with the FDA’s decision to scrutinize this dangerous device. Pulling pelvic mesh off the market is a step in the right direction, but only after the civil justice system raised serious health concerns. That job should have been done long ago — before thousands of women were needlessly injured.

Find additional information about POP and the use of pelvic mesh for patients and healthcare providers.

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