Government regulators, industry lobbyists and medical experts scrambled to get ahead of the International Consortium of Investigative Journalists’ latest investigation, the Implant Files, before the first word was even published.
Shortly before the first findings were due to be published, public safety organizations in both the United States and Europe announced new advice and renewed efforts to better protect patients.
ICIJ had sent questions to regulators around the world as part of the global investigation that found that failures to adequately test medical implants led to human harm — including injury and death.
Late last week, U.S. Food and Drug Administration Commissioner Scott Gottlieb issued a statement that committed his agency to a “more robust medical device safety net for patients through better data.”
The agency announced that its goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”
Earlier today, Gottlieb’s “Sunday Tweetorial” thread was about the agency’s future reform goals on medical devices.
ICIJ and its media partners first contacted the FDA with questions about medical devices in September.
After receiving the ICIJ inquiries and 11 days before publication, the FDA issued an alert to doctors and patients about the risks of one of those devices, pain pumps.
Faulty pain pumps were just one of many devices analyzed during the 12-month long investigation by 250 journalists from 36 countries. The investigation looked at suffering that resulted from the marketing and implantation of a variety of devices, including breast implants, replacement hips, heart valves and others developed by the fast-growing $400 billion global industry.
The pain pump alert warned that the devices, which deliver medication into the spinal fluid, may have serious complications, including dosing errors and pump failure. The complications can cause opioid withdrawal and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress. The alert noted that complications are “more frequent with the use of medicines not approved for use with the pump.”
The alert, which the FDA said was in response to reports from patients and doctors, also came one day after ICIJ informed the agency that its website had been modified to delete a sentence ICIJ had questioned about the safety and effectiveness of a popular pain pump.
On 20 Nov., the FDA also announced “new steps” for medical devices used by women, including mesh inserted to stabilize internal organs when pelvic muscles weaken, often after childbirth. Some forms of mesh have caused infection, pain, bleeding and other conditions requiring surgical intervention. It will convene an advisory committee meeting on the issue in February, the agency said.
The FDA wasn’t alone
In Europe, France’s Society of Plastic, Reconstructive and Aesthetic Surgery (SoFCPRE) announced last week that it “now recommends” against using textured “Biocell” breast implants manufactured by the French multinational, Allergan, because of “over-representation” in cases of a rare form of breast implant-related cancer, anaplastic large cell lymphoma. The announcement by the French organization followed months of reporting by ICIJ media partners.
Allergan told ICIJ that scientific evidence shows that its products are safe.
Hours after the announcement by the French surgeons’ group, France’s National Agency for the Safety of Medicines and Health Products (ANSM) announced that it too advised against textured breast implants, pending a review in 2019. On Nov. 23, two days after ICIJ’s media partners in France interviewed government officials for the Implant Files, ANSM also issued a call for patients and doctors to report “undesirable” consequences of vaginal mesh.
Dutch regulators acknowledged in response to questions from ICIJ and its partners that some manufacturers were not accurately reporting certain breast implant complications. A European taskforce has been convened to address the issue, regulators told reporters. ICIJ will publish the findings of its investigation into breast implants tomorrow.
In Spain, the Ministry of Health announced within hours of publication on Sunday that it would convene a meeting of health, science and patient organizations to discuss and respond to the findings of the Implant Files investigation.
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And from the private sector
The most explicit reaction to the impending publication of the Implant Files was a podcast interview with two top executives for the U.S. medical device trade group Advanced Medical Technology Association (AdvaMed).
AdvaMed’s CEO Scott Whitaker and head of public affairs Greg Crist discussed the upcoming ICIJ investigation, saying the organization had heard both from companies it represents and directly from ICIJ.
“When we heard of the questions, we realized it was something we should take seriously,” Whitaker told the podcast Pharma Intelligence.
AdvaMed said that it would “fight back with facts” against what the lobby group described as journalists with “a complete misunderstanding of the way the system works,” including using paid advertisements.
“We are bracing for a series of stories around the globe that casts the industry in a negative light,” Whitaker said. “It’s not just in the U.S….It’s in Europe, and it’s probably going to spread through Asia as well.”
“We’re going to push back,” Whitaker said. “And we’re going to push back really hard.”
Immediately following publication of the Implant Files, AdvaMed published a statement that claimed the project had overlooked the “overwhelmingly positive experiences of millions” of patients.
“Instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote.