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FDA Takes New Measures to Inform Women of Essure Risks

In April 2018, a national movement of women suffering from painful side effects caused by Essure achieved two major victories: On April 9th, the FDA ruled that health care providers can no longer implant Essure unless the doctor and patient review and sign an FDA-approved document outlining the risks. The following week, the FDA announced new …. Read More

FDA Releases Statement on Essure Postmarketing Review

On March 7, 2018, FDA Commissioner Scott Gottlieb released a statement regarding the agency’s ongoing monitoring and investigations into issues related to Bayer‘s controversial birth control device Essure. More than 750,000 women have received the implant since Essure’s approval in 2002. As of December 31, 2017, the FDA has received 26,773 medical device reports related …. Read More

Women in Scotland Sue Essure Birth Control Maker After Becoming Pregnant or Experiencing Severe Pain

Nine Scottish women are suing the makers of birth control device Essure after becoming pregnant post-implantation. The device was billed as a simple and safe procedure and an alternative to sterilization, yet many of the women claimed to have experienced excruciating pain, bloating, bleeding and infections. Moreover, the women who became pregnant while implanted with …. Read More

Essure Sales Banned Outside the U.S.

Following thousands of complaints lodged against Bayer, maker of permanent contraceptive device Essure, the company has discontinued sales and marketing of Essure in every country outside the United States. Essure has caused many women to experience unwanted side-effects including migrations, perforation of the uterus or other organs, and chronic pain—many even needing surgery to remove …. Read More

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