A week post Bayer’s announcement on the withdrawal of  Essure, its contraceptive implant from the market by this year-end due to inadequate sales, its clinical safety is questioned as consumer and legal stress builds up concerning complaints of extreme fatigue, pain and bleeding.

The company labeled safety concerns as “based on anecdotal reports, rather than science,” trying to convince women and healthcare providers that no “reliable scientific evidence” points at new issues with the permanent birth control implant, aiming to curtail the FDA’s adverse event system.

“While Bayer takes any adverse event report seriously, the FDA has repeatedly cautioned that adverse event reports can be ‘incomplete, inaccurate, untimely, unverified or biased’ and duplicative, and that adverse event reports alone cannot be used to determine rates of events or causation,” the company said in a statement.

The FDA asked Bayer to perform a postmarket safety study and printed a boxed warning to Essure’s packaging. The agency also included a decision checklist to be filled by new patients, to ensure their complete awareness of the device’s hazards and benefits, resulting in a drop in sales by about 70%, the FDA said. FDA Commissioner, Scott Gottlieb, said that 12,000 reports related to Essure were received last year, with about 90% linked to the impending elimination of the device, which might necessitate a hysterectomy.

“Most of this new information comes from cases that were made available by plaintiff attorneys as part of litigation against the product sponsor,” Gottlieb said in a statement previously this year. “We appreciate any opportunity to receive additional information about the safety of this product.”

Essure has already been pulled off from markets in the rest of the world. Bayer commented it will persist to register patients in the requisite post-market surveillance study.