Follow Up Email to FDA Commissioner Gottlieb
Sent March 2, 2018
Essure Problems Admins just emailed FDA Commissioner Scott Gottlieb, requesting immediate action be taken concerning Essure. The group, along with attorneys Holly Ennis, Marcus Susen, and Justin Parafinczuk, and medical data specialist Madris Tomes from Device Events, met with Commissioner Gottlieb at the FDA office on February 7, 2018 requesting that Essure be suspended and the product removed from the market pending the outcome of the current clinical trials, which will not be completed until 2023. The group presented data and reasons why it is imperative to suspend Essure in the U.S., as it has already been pulled worldwide.
Below is the follow up letter that was emailed to Commissioner Gottlieb and all of the FDA officials who attended that meeting on February 7th, 2018.
March 2, 2018
We wanted to follow up with you with some more information regarding Essure, and why we find it essential that the FDA suspends its use in the US until further testing results are complete. The following link will take you to a google folder with documents we have shared with you.
In the time since our meeting, as of 3/1/2018, 30 more women joined our group who were offered Essure (3 actually implanted) and not given the black box warning, the patient checklist, or told that the product was under active FDA review (i.e. new clinical studies).
That brings the total now to 506 women who never got the black box warning or patient checklist, out of 517 women. (169 women implanted of the 517)
In the following studies of essure, the safety and efficacy of the device is proving not to be what was presented at the time of the original PMA approval.
Yale study shows higher pregnancy rates with Essure
Conclusion: Based on available data, the expected population risk of pregnancy is higher after hysteroscopic than laparoscopic sterilization
BMJ Study shows 10x higher reoperation rate with Essure
Conclusion: Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization.
Among the entire cohort, 1394 surgical procedures were performed after sterilization. The Essure group was significantly more likely to undergo surgeries, and hysteroscopies and resterilization were more common in the Essure group.
In summary, all three surgical methods offer similar contraceptive efficacy. Surgery post-sterilization is more likely after hysteroscopic Essure device insertion.
During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated.
“Results according to allergy history (P value for interaction = .001): in women who had prior allergies, hysteroscopic sterilization was associated with a significantly higher risk of developing an allergic reaction during follow-up than laparoscopic sterilization. A significant interaction with allergy history was found."
(Also see “review of French study” in google folder)
We also strongly believe that the citizens petition was never addressed or investigated thoroughly https://www.regulations.gov/docket?D=FDA-2015-P-0569 , and that the case report review by Ron Yustein was highly inadequate.
(See “affidavits” and “case report reviews” in google folder)
In 1992, The FDA announced a voluntary moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that had been submitted. We find that there is no reason why the FDA should not do the same with Essure.
Also included in this folder are two letters from physicians, the graphs presented by Madris Tomes at our last meeting, some highlights from the 2015 FDA transcript, the reasons we find Essure should be suspended, the opening statement made by Angie Firmalino at our meeting, and the previous 483 issued to Dr. Basinski who is a current Essure trial physician.
We find it imperative that you take action soon for the safety of all American women. Please take the time to look over these documents with care, as we are relying on you to make the right decision and suspend the Essure device. Since our meeting last month, 584 additional adverse events have been reported to the FDA, 534 were device removal surgeries. Migration reports alone jumped to over 4000.
These women do not have the luxury of time while this device remains on the market. We look forward to your timely response and hope you make your decision based on your position to protect the American people.
The Essure Problems Admins, the tens of thousands of women harmed by this device, and their loved ones.