 |
| Essure--Screenshot courtesy of Bayer |
Bayer has faced a rocky road with its contraceptive implant Essure, with the FDA launching an investigation earlier this year following claims of harmful--and in some cases, lethal--side effects and false trial data for the product. Now the company is facing more pushback after an FDA panel came down on the company for not collecting key safety data for its device.
In a daylong public meeting organized by the agency, an independent panel grilled the FDA and Bayer about Essure, with some experts asking how potentially serious side effects could have gone unnoticed, The New York Times reports. The product, which consists of two flexible metal fiber coils placed in the cervix, is partly made from nickel. And some say that the material could have triggered allergic reactions in women who received the implant.
"How can Bayer and the FDA have no knowledge of nickel allergies?" said Peter Shalock, a dermatologist at Massachusetts General Hospital, as quoted by the NYT. "Where did you test these people? How did you test these people? What did you test them with? Are we just making this up for fun or is there data?"
The panel also chastised the FDA for approving Essure without a gold-standard, randomized clinical trial, and asked the agency and Bayer to look at why women are still experiencing severe pain from the implants, The Wall Street Journal reports. While the agency is not bound by the advice of the panel, it generally follows its recommendations.
The panel meeting could have negative implications for Bayer, as it continues to defend Essure amid growing backlash. The FDA has received more than 5,000 complaints about the product since it was approved in November 2002, with most of those from after Bayer picked up the product through its $1.1 billion deal for Conceptus in 2013. And the number of complaints is only increasing, jumping nearly 20-fold to 2,259 in 2014 from 115 in 2011.
In April 2014, the FDA said it would investigate the product. Bayer then released data from a 5-year follow-up study showing that Essure caused pelvic pain in only 7% of participants. Some experts in the field struck back, citing results from a trial which found that only 366 of 518 participants in the original study were followed for the full 5 years and that some women still experience serious problems with the device.
But Bayer is standing by its product, saying that the device has been studied in more than 10,000 women since it was first developed and that its benefits outweigh the risks in some patients, the company said in a statement.
"There's a need for safe and effective options for permanent birth control for women who have decided they've completed their families and that's what Essure can provide for appropriate patients," Dr. Dario Mirski, VP and head of U.S. medical affairs at Bayer, said in a statement. "Bayer stands by the positive benefit-risk profile of Essure, and we look forward to working closely with the FDA as it considers the Panel's advice."
- read the NYT story (sub. req.)
- here's the WSJ article (sub. req.)
- get Bayer's statement
Special Report: Med tech M&A gets much, much bigger during the first half - Bayer doesn't conceive with Conceptus