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FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.

The first pelvic mesh products for women received fast-track approval from the FDA because they were deemed similar to mesh long used to treat hernias. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data establishing their devices’ safety for pelvic collapse before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify the devices.

“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.

J&J spokeswoman Sheri Woodruff said in a statement late Tuesday that J&J stopped selling its pelvic prolapse mesh products in 2012, “in light of changing market dynamics.” The company continues to sell mesh to treat stress urinary incontinence, which causes bladder leaks.

Woodruff said those devices “are considered by many to be the gold standard of treatment” for incontinence.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.

The first pelvic mesh products for women received fast-track approval from the FDA because they were deemed similar to mesh long used to treat hernias. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data establishing their devices’ safety for pelvic collapse before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify the devices.

“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.

J&J spokeswoman Sheri Woodruff said in a statement late Tuesday that J&J stopped selling its pelvic prolapse mesh products in 2012, “in light of changing market dynamics.” The company continues to sell mesh to treat stress urinary incontinence, which causes bladder leaks.

Woodruff said those devices “are considered by many to be the gold standard of treatment” for incontinence.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.

The first pelvic mesh products for women received fast-track approval from the FDA because they were deemed similar to mesh long used to treat hernias. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data establishing their devices’ safety for pelvic collapse before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify the devices.

“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.

J&J spokeswoman Sheri Woodruff said in a statement late Tuesday that J&J stopped selling its pelvic prolapse mesh products in 2012, “in light of changing market dynamics.” The company continues to sell mesh to treat stress urinary incontinence, which causes bladder leaks.

Woodruff said those devices “are considered by many to be the gold standard of treatment” for incontinence.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.

The first pelvic mesh products for women received fast-track approval from the FDA because they were deemed similar to mesh long used to treat hernias. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data establishing their devices’ safety for pelvic collapse before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify the devices.

“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.

J&J spokeswoman Sheri Woodruff said in a statement late Tuesday that J&J stopped selling its pelvic prolapse mesh products in 2012, “in light of changing market dynamics.” The company continues to sell mesh to treat stress urinary incontinence, which causes bladder leaks.

Woodruff said those devices “are considered by many to be the gold standard of treatment” for incontinence.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.

The first pelvic mesh products for women received fast-track approval from the FDA because they were deemed similar to mesh long used to treat hernias. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data establishing their devices’ safety for pelvic collapse before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify the devices.

“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.

J&J spokeswoman Sheri Woodruff said in a statement late Tuesday that J&J stopped selling its pelvic prolapse mesh products in 2012, “in light of changing market dynamics.” The company continues to sell mesh to treat stress urinary incontinence, which causes bladder leaks.

Woodruff said those devices “are considered by many to be the gold standard of treatment” for incontinence.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children – and often the cause of embarrassing bladder leaks. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The first mesh products received fast-track approval from the FDA because they were deemed similar to mesh long used to repair hernias. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data establishing their devices’ safety before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by pelvic mesh are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

Gay Courter of Crystal River, Fla., said she was “heartened” by news that the FDA plans to reclassify mesh.

“We look to the FDA to protect women because corporations who profit from these products have not responsibly done long-term testing or reporting of adverse events,” said Courter, one of several mesh patients who spoke against J&J at its annual shareholders meeting last week.

Calls placed to J&J’s Ethicon division, which sells the pelvic mesh, were not returned Tuesday afternoon.

Other manufacturers include Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If finalized, the change would require manufacturers to prove that their mesh products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children – and often the cause of embarrassing bladder leaks. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had gradually worn through the vaginal wall into the surrounding tissue or organs. More than half of these women require follow-up surgery to remove the mesh – sometimes two or three procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The first mesh products received fast-track approval from the FDA because they were deemed similar to mesh long used in hernia surgeries. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data proving their devices are safe before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by pelvic mesh are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Attorneys representing women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

In February, U.S. District Court Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded J&J destroyed thousands of documents regarding development of its pelvic mesh implants, but said there was no proof that was done intentionally. The documents would include reports on patient testing of the mesh implants and could show whether participants suffered serious complications.

Other manufacturers of pelvic mesh include Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If finalized, the change would require manufacturers to prove that their mesh products are safe and effective before they can be sold.

Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children – and often the cause of embarrassing bladder leaks. The most common technique for implanting the mesh involves a surgical insertion through the vagina.

The FDA’s proposal comes nearly three years after the agency first concluded that women getting mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had gradually worn through the vaginal wall into the surrounding tissue or organs. More than half of these women require follow-up surgery to remove the mesh – sometimes two or three procedures.

Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, chief scientist for the FDA’s device center.

The first mesh products received fast-track approval from the FDA because they were deemed similar to mesh long used in hernia surgeries. At the time the FDA classified all pelvic mesh as a “moderate-risk,” device, not subject to the rigorous testing of high-risk implants. Under Tuesday’s proposal, companies would have to submit clinical data proving their devices are safe before gaining FDA approval. The agency will take comments on the plan for 90 days.

Injuries caused by pelvic mesh are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.

Attorneys representing women suing the company allege that New Brunswick, N.J.-based J&J was aware of the risks of its product but did not warn the public.

In February, U.S. District Court Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded J&J destroyed thousands of documents regarding development of its pelvic mesh implants, but said there was no proof that was done intentionally. The documents would include reports on patient testing of the mesh implants and could show whether participants suffered serious complications.

Other manufacturers of pelvic mesh include Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems.

FDA wants stricter safety rules for pelvic mesh

KDWN

WASHINGTON (AP) — Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.

The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a high-risk medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If finalized, the change would require manufacturers to prove that their mesh products are safe and effective before they can be sold.

The proposal comes nearly three years after the agency concluded that women getting mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were initially viewed as a high-tech improvement to surgery, but FDA said there is no evidence they improve safety outcomes.