In April, the Food & Drug Administration ordered manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling their products because there was no “reasonable assurance” that they were safe. Ethicon still faces more than 22,000 pelvic mesh lawsuits. More than 80 are still pending in the Philadelphia’s Complex Litigation Center, alone.
Serious surgical mesh complications
Patricia Mesigian, like many other women, suffered and continues to suffer serious side effects from her original 2008 surgery. Shortly after the first procedure, she started bleeding vaginally. Corrective surgery revealed that a portion of the mesh had cut into her vagina. Four years later, she began bleeding again and sex had become painful.
She underwent a third surgery to remove more of the mesh. From 2013 to 2017, she had three more operations and several other treatments to remove scar tissue. She is left with chronic pain, and her family relationships have suffered.
Her situation is not uncommon. Approximately 200,000 inpatient surgical procedures are performed for pelvic organ prolapse in the U.S. each year. In recent years, surgeons have increasingly turned to synthetic and biologic mesh for the procedure. During the same period, more women have begun to report painful complications.
The most serious of these, according to the FDA, are infection, pain, urinary problems, vaginal scarring and recurrence of prolapse and or incontinence. The mesh also erodes, gradually dislodging from the vaginal wall where it was implanted and moving into the surrounding tissue and organs. The mesh may protrude from the opening of the vagina, in a complication described as “extrusion” or “exposure.” The FDA has noted some cases of vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including painful intercourse.
Because transvaginal mesh is considered a permanent implant, surgery to remove the mesh can be difficult and may increase a woman’s risk of additional complications or symptoms. Over time, the tissue grows into and around the mesh, so removing the mesh without damaging the surrounding tissue and organs is a delicate process. In some cases, complete removal is not possible. Pain and recurring infections become a permanent state of life.
Incontinence mesh uses similar graft material, and patients may suffer from similar symptoms postoperatively. Complications arising from the use of synthetic mesh to repair abdominal hernias have also been reported.
Did Johnson & Johnson and Ethicon hide the truth?
The essence of these surgical mesh lawsuits is not just that the mesh was dangerous, but that J&J and Ethicon either knew or had reason to know that it was defective and either deliberately or negligently hid that evidence from doctors and patients. Every lawsuit is different, but the kinds of arguments that arise in these cases may include:
• First, that the manufacturers knew about the safety problems and misled the FDA to obtain approval;
• Second, that the deception continued through marketing efforts directed at the public and the medical community;
• Third, that manufacturers did not conduct adequate clinical trials in order to determine whether or not their products were safe and effective for treating pelvic problems in women;
• Fourth, that the manufacturers did not establish safe, effective methods for removing the mesh in the event of complications; and
• Fifth, that the manufacturers hid their growing suspicion that these devices could result in permanent injuries and death, even though they had an ethical obligation to make that disclosure.
Big awards, many pending lawsuits
Court watchers note that the Mesigian lawsuit was the eighth in this court for women suing Ethicon for pelvic mesh injuries. This latest jury award brings the total judgments so far to more than $346 million. Ethicon has prevailed in comparatively few surgical mesh lawsuits.
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Large punitive damage awards are always susceptible to reduction on appeal. Nonetheless, Ethicon and its corporate parent, Johnson & Johnson, may be less concerned about the size of the awards than they are about the number of lawsuits still in the litigation pipeline. The numbers are compiled and reported in a variety of ways – some including hernia mesh lawsuits, some limited to pelvic organ prolapse lawsuits. At a minimum, however, the reporting suggests that tens of thousands of lawsuits are still pending, even after the offending product has been removed from the market.
Although Ethicon may continue to defend these surgical mesh lawsuits for the near future, many expect to see settlement negotiations develop soon.