The first lawsuit has been filed against Bayer HealthCare because of alleged complications caused by permanent birth control device, Essure.
The lawsuit, filed in Philadelphia civil court, accuses the manufacturer of intentionally misleading women implanted with Essure and violating the conditions upon which the company received premarket approval from the Food and Drug Administration (FDA).
The complaint states, Essure “should never have been marketed or sold” to Plaintiff, Heather Walsh.
Essure is marketed as permanent birth control without surgery. During the procedure, two metal coils are placed inside the fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.
The lawsuit also claims the company “failed to adequately train [Walsh’s] implanting physician”. Three – not two – metal coils were found inside Walsh, according to the lawsuit. The coils migrated out of her fallopian tubes and, eventually, led to five hospitalizations, a hysterectomy, and auto-immune and adhesion disorders.
The lawsuit is against Bayer, which purchased Essure from Conceptus, the original manufacturer of the device.
Famed consumer advocate, Erin Brockovich helps lead the campaign against Essure. When she spoke with the ABC15 Investigators last year, she questioned the premarket approval the device received from the FDA.
“The company got premarket approval for studies that could clearly be questioned,” she said.
Normally, premarket approval shields a company from any product liability. But, this lawsuit claims that Essure’s manufacturer broke the conditions for that approval, making the Conditional Premarket Approval “invalid” and the product “adulterated.”
The lawsuit accuses the manufacturer of “actively concealing” negative reports about the device from the FDA.
Lawyers are asking for $50,000 for both compensation and delay damages.
The ABC15 Investigators began reporting on Essure nearly a year ago, when dozens of women across the state came forward to talk about their issues after getting the device . Common complaints include bloating, excessive bleeding, rashes and chronic pelvic pain. Women also told us about serious issues they say resulted from Essure, such as miscarriages and ectopic pregnancies.
After our reporting, the manufacturer, Bayer Health Care, added warnings to the product label , and the Food and Drug Administration (FDA) conducted a review of the Adverse Events reported about the device.
Bayer had no comment on the lawsuit.
Bayer told the ABC15 Investigators they have read the stories from the women who are sharing their experiences with Essure, but they do not believe they represent the hundreds of thousands of women who have gotten the Essure coils implanted since the device was approved by the FDA in 2002.
See Bayer’s complete statement below.
For months, the FDA has told ABC15 they reviewed all of the reports of problems related to Essure and the clinical trial literature, and found “no literature… that has indicated any new or more widespread complications definitely associated with Essure more than five years after Essure placement.”
When asked about this lawsuit, FDA spokeswoman Jennifer Rodriguez said “the FDA does not comment on possible, pending or ongoing litigation.”
See the FDA’s complete statement below.
Complete Statement from Bayer:
Bayer provided ABC15 with the following statement and this video link from Edio Zampaglione, MD, FACOG, US Medical Affairs, Bayer HealthCare:
(To download the video, only use the link provided. No email or password is required. If it asks you for that, please reopen your server and try the link again.)
At Bayer, our mission is to create drugs and devices that help people. Patient safety is very important to us, and we have great sympathy for anyone who is experiencing pain, regardless of the cause. We have also read the stories from women who are sharing their personal experiences with Essure. These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002.
As the manufacturer of this product, we have a responsibility to share the facts about Essure with you and your viewers:
· We take all adverse events seriously. Most of the side effects that have been reported recently about Essure are known and included in the Essure Instructions for Use information. This was confirmed by the FDA which found that “[a]lthough there is evidence of complications, as there are with all medical devices, overall results from [a five year safety] study did not demonstrate any new safety problems or an increased incidence of problems already known.”
· Essure has more than a decade of research and development in addition to a decade of real world experience. More than 750,000 devices have been sold worldwide. Essure has been shown to be highly effective in preventing pregnancy (99.83% based
on a 5 year study) and the safety profile has been documented through numerous clinical trials. The American College of Obstetricians and Gynecologists (ACOG) has recognized that “hysteroscopic tubal occlusion for sterilization [Essure] has high efficacy and low procedure-related risk….”2
· More than 600,000 tubal ligation procedures are performed in the United States each year.3 We stand by the benefit-risk profile of Essure as an important option available to women who want non-surgical permanent contraception.
No form of contraception is without risk, should be considered appropriate for every woman or is 100 percent effective. As with any drug or device, it is important that women discuss the risks and benefits of any birth control option with their physicians.
Complete statement from the FDA:
The Essure clinical trial design and outcomes were discussed in detail during a day-long public meeting of the FDA’s Advisory Panel for OBGYN Devices, where the recommendation of the expert Panel was that FDA approve the Essure device. Essure has been shown in a rigorous prospective clinical trial with 5-year follow-up to be extremely effective at preventing pregnancy, which is the intended use of the device. The device labeling (physician and patient) describes risks of the procedure. The currently available alternative to Essure for permanent female sterilization requires at a minimum laparoscopic surgery (including a skin incision and general anesthesia).
The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from a five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. We take reports of problems with Essure very seriously and will continue to review them carefully. We will continue to monitor the safety of this product to make certain its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.