Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday.
The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”
Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency’s statement.
“We couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
Women who have had transvaginal mesh surgically implanted should “continue with their annual and other routine check-ups and follow-up care,” the FDA advised. “There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms.”
Patients who have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, should notify their health care professionals. Women who may have been planning a surgical mesh procedure should discuss other options with their doctors.
Public Citizen, a consumer advocacy organization, petitioned for a ban against the mesh products in 2011 and then testified before an FDA advisory committee earlier this year, according to Dr. Michael Carome, director of the nonprofit’s Health Research Group.
“Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices,” Carome said in a statement Tuesday. “Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits in comparison to nonmesh products.” He added that “the agency’s reckless delay in removing these mesh products from the market belies” Shuren’s assertion that patient safety is the FDA’s highest priority.
“If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm,” said Carome.
Medical device safety
The FDA said its Tuesday action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it “regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide.”
Last year, the FDA released its Medical Device Safety Action Plan, a program intended to overhaul the process for manufacturers that want to market medical devices in the nation.
It was released around the same time as a year-long investigation by the International Consortium of Investigative Journalists, which included more than 250 journalists based in 36 countries and examined more than 8 million device-related health records. In addition to uncovering thousands of deaths and millions of injuries presumably caused by medical implants, the report known as the “Implant Files” also claimed that manufacturers have paid out at least $1.6 billion across the globe to settle charges of regulatory violations, including corruption and fraud.
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“Patients around the world have become unwitting test subjects for new medical technology,” the consortium stated. “Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants.”