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FDA moves transvaginal mesh implants to “high risk” category

March 1st, 2016

The U.S. Food and Drug Administration (FDA) has raised the risk profile of transvaginal mesh implants used to treat pelvic organ prolapse in women from “moderate” to “high risk.” The move requires mesh manufacturers to submit pre-market approval applications to the FDA in order to better understand the risks associated with the devices.… read more »

Johnson & Johnson settles first transvaginal mesh lawsuits

January 30th, 2015

Johnson & Johnson has settled four transvaginal mesh lawsuits alleging that the company’s mesh devices caused serious injuries in women. The lawsuits were the first four to be tried against J&J—also known as “bellwether trials”—and likely indicate that more transvaginal mesh settlements could be coming soon. J&J faces more than 23,000 transvaginal mesh lawsuits alleging that devices manufactured by its… read more »

Manufacturer to settle transvaginal mesh lawsuits

December 12th, 2014

Medical manufacturer Endo International PLC plans to settle a substantial number of transvaginal mesh lawsuits filed against the company’s American Medical Systems unit. The company will pay $830 million to patients who alleged that transvaginal mesh from American Medical Systems (AMS) caused severe complications and side effects.   Patients who received an AMS transvaginal mesh device to treat pelvic organ… read more »

Australian government health department finds transvaginal mesh ineffective

October 17th, 2014

The Australian Therapeutic Goods Administration (TGA) has conducted a review of transvaginal mesh patch devices and found little evidence to support the overall effectiveness of the surgical mesh. The TGA will now reassess clinical trials conducted on individual transvaginal mesh products to determine their safety.   Trasnvaginal mesh patches were approved to treat conditions such as pelvic organ prolapse (POP)… read more »

Advocacy groups urge FDA to reclassify transvaginal mesh

October 3rd, 2014

Several advocacy groups in the U.S. are urging the Food and Drug Administration (FDA) to reclassify transvaginal mesh as a Class III medical device. A Class III device is one for which “insufficient information exists to assure safety and effectiveness” that is evident in a Class I or Class II device. Consumers Union, which is the advocacy arm of Consumer… read more »

Texas jury hands down $73.4 M verdict in transvaginal mesh lawsuit case

September 19th, 2014

A Texas jury has found Boston Scientific Corp. guilty in a transvaginal mesh lawsuit, handing down a $73.4 million verdict against the company. The jury sided with a patient who charged that Boston Scientific’s Obtryx-brand transvaginal sling was defectively designed, ultimately causing several severe injuries. The decision marks the first time Boston Scientific was found liable by a jury for… read more »

FDA denies citizen petition to ban transvaginal mesh despite injuries

September 12th, 2014

The U.S. Food and Drug Administration has rejected a petition from the Public Citizen’s health resource group, which aimed to ignite a global transvaginal mesh recall. Despite the FDA’s refusal to issue a recall, the agency acknowledged serious concerns with mesh devices, ordering 126 manufacturers to review the safety of their products and proposing to reclassify the devices as “high read more »

Texas women urge attorney general to pursue transvaginal mesh lawsuit against manufacturer

August 8th, 2014

A coalition of Texas women is urging Attorney General Greg Abbott to file a transvaginal mesh lawsuit against manufacturer Johnson & Johnson. The women allege that J&J violated state laws of deceptive business practices after releasing transvaginal mesh devices that caused serious injuries to thousands of women. read more »

Doctors at American Urological Association meeting argue against transvaginal mesh

June 18th, 2014

Doctors and researchers gathered at a recent American Urological Association (AUA) meeting to discuss the risks of transvaginal mesh. The AUA has reconsidered its stance on the use of transvaginal mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) due to the number of women complaining of severe complications after surgery.… read more »

FDA proposes increased transvaginal mesh regulation

June 3rd, 2014

The U.S. Food and Drug Administration (FDA) announced proposed increased regulation of transvaginal mesh implants that have caused tens of thousands of injuries in women. Transvaginal mesh was approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse, but many of the mesh devices have been found to have a higher than expected rate of failure, often leading to… read more »

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