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FDA Halts Pelvic Mesh Sales Over Safety Concerns

Defective products are a common cause of personal injuries. Faulty medical devices, in particular, are dangerous and can leave patients suffering serious, potentially life-threatening complications. In terms of medical controversy and concerns over safety issues, mesh devices frequently used in surgical procedures have been making headlines and resulting in patient lawsuits for a number of years. Recently, federal regulators took the dramatic step of halting sales of a common type of pelvic mesh used frequently to treat women with a variety of pain disorder over safety concerns. The following highlights what you need to know about the issue.

Pelvic Mesh Among Women

Surgical mesh has proved invaluable in treating certain medical conditions, such as hernias and urinary incontinence. However, there has also been a long history of complaints and complications related to mesh use. According to an April 17, 2019 report in the Insurance Claims Journal, the U.S. Food and Drug Administration (FDA) has taken the dramatic step in halting the sale of pelvic mesh by two of the main manufacturers, Boston Scientific and Coloplast, in response to safety concerns. The action follows general warnings the FDA issued in 2016 regarding the potential dangers associated with these and similar types of devices.   

Pelvic organ prolapse is a common problem among women, affecting roughly 25 percent of the female population in the United States to some degree. If left untreated, it can result in pain and bulging in the pelvic region while leading both to urinary and fecal incontinence. According to the Women’s Health Center at the West Portland Physical Therapy Clinic, pelvic prolapse can happen when organs such as the bladder, urethra, uterus, or rectum fall out of their usual positions. Milder cases can be treated through postural alignment and lifestyle changes, which include dietary modifications and performing specific exercises. However, when pelvic prolapse is more severe, surgery may be a woman’s only option.

Safety Concerns About Pelvic Mesh

According to the FDA, roughly one out of every eight women has surgery to correct pelvic organ prolapse at some point in her lifetime. While pelvic mesh provided what doctors at first thought was a safe, effective way of treating the condition transvaginally and avoiding more major surgeries, it did not take long before reports regarding complications began flooding in. Among the common problems experienced by women who have had pelvic mesh implanted include:

  • Chronic pain in the pelvic region;
  • Fever and infection;
  • Pain during intercourse;
  • Bleeding and urinary problems
  • Exposure of the mesh through the vagina.

For women who have undergone surgical mesh implant procedures, if you experience these or other symptoms it is important to contact your medical provider immediately.

Our Portland Personal Injury Attorneys Are Here to Help

Complications from mesh implants can endanger your health while removing the mesh involves additional painful procedures. At the Johnston Law Firm, we can assist you in holding mesh manufacturers accountable for your suffering and the expenses you incur.  Contact our Portland personal injury attorneys online or call (503) 546-3167 and request a free consultation to discuss how we can help you today.  


Marc Johnston

Lead Attorney at Johnston Law Firm, P.C.

Based in downtown Portland, Marc A. Johnston is the owner and managing attorney of the award-winning, internationally-known personal injury law firm, Johnston Law Firm, P.C. Marc's career has been dedicated to representing the injured and individuals who have been treated unfairly by an insurance company. His focus on trial law creates the backbone of the Johnston Law Firm — a firm that is ready to go the distance in seeking justice for its clients.