FDA bans mesh implants: The stories that led to the action

On Behalf of | Apr 19, 2019 | Firm News

Pain. Infection. Bleeding. Urinary problems. These sound like symptoms of a medical issue for which you may seek treatment. Instead, these are the complications that hundreds of thousands of women have suffered as the result of their medical treatment.

We are talking about the vaginal mesh implants medical providers used to treat pelvic organ prolapse (POP). These implants proved to be dangerous, resulting in more than 100,000 lawsuits over the past couple of decades. On Tuesday, April 16, the U.S. Food and Drug Administration ordered manufacturers to stop selling the product.

Painful and disabling complications altered lives forever

There is no doubt that this is a big win for women. If a woman suffering POP seeks treatment, doctors cannot implant a product that is not available and thus cannot suffer complications. While there is a win to celebrate, it came at a great cost to the individual women who suffered.

When surveyed, 69.3% of women who suffered complications reported that they left them with marked or extreme disabilities. These disrupted their work, school, social life, leisure activities, family life and home responsibilities.

The word “complication” does not do justice to the damage done. It doesn’t capture the life-changing financial, physical and emotional harm the complications caused so many women. Here are a few of their stories:

  • A family that missed out on life together: For one mother and wife, her complications left her bed-ridden for nearly 20 years from either the pain alone or while recovering from her 12 surgeries, the last of which cost $8,000. She felt that not only did she miss out on life, but her children grew up with a mom who couldn’t actively participate in their lives and a husband who didn’t get intimacy.
  • They should have known better: “May they rot in hell,” said another mom of three when she explained that doctors didn’t tell her about class actions people were filing when they gave her a transvaginal mesh implant. The implant ended up taking away many things she used to be able to do and left her with “depression, chronic pain and discomfort and continuous bladder prolapse issues.”
  • Unable to have a sexual relationship: Intimacy is a vital part of a relationship, but a woman whose doctors never warned her of the complications admitted that they ruined two relationships and countless future potential ones. “I feel I can no longer have a sexual relationship, which has left me feeling depressed and alone,” she said.
  • I nearly ended my life: For one registered nurse, the nearly 30-year spasms that “felt like the front of [her] was being pulled to the back” had sent her into a serious state of depression. After three operations, she could reduce her chronic pain to a level that she could have a “reasonable life.”

These stories are real, personal and painful. The worst part is that there are so many more. Removing the device from the market helps, but there are lessons to be learned. Everyone from medical device manufacturers to doctors to the FDA should all ask the question, “What can we do better?”

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