American Medical Systems, which manufactures transvaginal mesh devices, received a warning letter from the U.S. Food and Drug Administration (FDA) regarding issues the organization found at a facility run by the company. These included risk analysis and process validation procedures.
The U.S. Food and Drug Administration released a statement announcing two proposals addressing the serious health risks linked to surgical mesh used for transvaginal repair following a pelvic organ prolapse (POP).
Endo International PLC., the parent company of American Medical Systems (AMS), was issued a letter of warning from the U.S. Food and Drug Administration (FDA) following an inspection of the facility where it found three federal regulation violations against how some urological devices and transvaginal mesh are manufactured.
A pelvic organ prolapse, or POP, occurs when pelvic organs droop or descend.
Johnson & Johnson was recently ordered to pay a woman for pain caused by its transvaginal mesh device.
Girls in the U.K. may soon have increased access to IUDs.
It’s important that women realize that if they do experience infertility or any other complications due to Mirena, they can seek compensation with the help of an experienced attorney.
Two types of POP treatment carry less risk of complications than transvaginal mesh.
A transvaginal mesh maker just settled about 400 lawsuits for $16 million.
For some women, the removal of Mirena can be just as harmful as keeping the IUD.