Responding to a panel advocates that say women have been harmed by vaginal mesh, U.S. regulators are requesting that 33 vaginal mesh manufacturers provide clinical studies investigating the effectiveness and safety of this device.
The United States Food and Drug Administration (FDA) wrote Johnson & Johnson, C.R. Bard, Inc. and 31 other transvaginal mesh manufacturers telling them to conduct three years worth of clinical trials on safety and effectiveness. A report released by the agency in July found a fivefold jump in injuries, malfunctions and even deaths associated with the products.
In 2010, approximately 300,000 mesh devices were implanted in women to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Since then, approximately 650 lawsuits have been filed by women who allege they have been hurt by the device. Also, there has been heightened scrutiny of the FDA for approving this device without prior human testing.
Lana Keeton, a patient advocate from Austin, Texas, said "Now these companies are going to have to tell the truth."
The FDA's letters ask manufacturers to collect data on the results and possible complications of these procedures. During a transvaginal mesh surgery, a synthetic mesh is inserted through the vagina to help with symptoms of POP and SUI. In July 2011, the FDA released a formal warning against the device, although noting that it did not have enough data to warrant a ban on the device. However, it did strongly encourage physicians to seek other treatments.
Pelvic organ prolapse, or POP, is a condition in which the pelvic organs, most commonly the bladder, slip out of place and bulge into the vagina. This is a result of weakened pelvic muscles due to multiple childbirths or undergoing a hysterectomy or other abdominal surgeries.
Vaginal mesh implants also treat stress urinary incontinence, or SUI, which is involuntary loss of urine during physical activity like sneezing, coughing, laughing, or exercising.
"We believe there are certain uses of mesh where we need additional data to help guide the clinical community," said Maisel, deputy director of science for the agency's device approval center. "Our goal is to make sure the right women use it at the right time."
Vaginal surgical mesh was approved through the FDA's 501(k) system, where medical devices do not required pre-market testing prior to approval. Instead, manufacturers only have to prove that there are similar devices on the market that are safe and effective.
Johnson & Johnson is based in New Brunswick, New Jersey and C.R. Bard is based in Murray Hill, New Jersey.
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