Breast Implant Safety Alliance (BISA) Reflects on FDA Leadership Changes and Potential Impact on Breast Implants
With Dr. Michelle Tarver’s appointment as the new director of CDRH, BISA hopes for stronger patient-focused oversight, contrasting with past controversies.
This is important because changes in FDA staff and policies can have significant implications for patients considering or currently living with breast implants and other medical devices.
In this article:
What is the CDRH?
Announcement of new CDRH Director Dr. Michelle Tarver
Controversy surrounding past CDRH Directors Dr. Jeff Shuren & Dr. Daniel Schultz
Potential impact on breast implant safety
Going Forward
What is the CDRH at FDA?
The Center for Devices and Radiological Health (CDRH) is a branch of the FDA responsible for overseeing the regulation of medical devices and radiation-emitting products in the United States. This includes devices like breast implants, pacemakers, and surgical tools.
The Director of CDRH makes sure these products are safe and effective before they are sold to the public and monitors their safety once they are on the market. In this role, the Director works with scientists, doctors, and the medical industry to create rules about how devices are tested and approved. They also help decide what should happen if a product is found to be unsafe, such as recalling it from the market.
This role at the FDA is important for protecting public health and making sure that patients have access to safe and effective medical technologies and it is imperative that officials and doctors in this position avoid situations where personal conflicts of interests could affect their professional decisions. In healthcare, a conflict of interest can lead to unsafe products, delayed actions, loss of trust, and direct harm to patients.
New Director of CDRH Announced October 2024
Dr. Michelle Tarver, Director of CDRH
On Tuesday, October 22, 2024, the FDA named Dr. Michelle Tarver as the permanent director of the agency’s device center. She was appointed as acting director of the Center for Devices and Radiological Health in July, when longtime leader Dr. Jeff Shuren stepped down. Dr. Tarver has extensive experience in medical devices, patient safety, and regulatory science. She has previously held leadership roles at the FDA, focusing on patient engagement and advancing health equity. She also often emphasizes the importance of listening to patients.
BISA president Maria Gmitro was quoted in the New York Times discussing BISA’s past experience with Dr. Tarver:
Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.
Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.
“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”
BISA hopes this new appointment will strengthen the agency’s focus on patient-centered approaches and improve regulatory practices for medical devices especially considering the concerns and criticism of former Directors of CDRH.
Controversy Surrounding Past FDA CDRH Directors
Past directors of CDRH have faced challenges during their tenure, with decisions that attracted scrutiny and sparked debate over regulatory practices. Dr. Jeff Shuren served as Director from 2010 until 2024. Shuren took over for Dr. Daniel Schultz who served as Director from 2004 until 2009. Shuren has been credited for helping to stabilize the FDA’s medical devices center following the turbulent exit of Schultz.
Dr. Jeff Shuren, CDRH Director 2010 - 2024
Dr. Jeff Shuren has been at the helm of the CDRH since 2009. With a medical degree and a background in law, he has played a key role in shaping policies affecting a wide range of medical devices, from surgical instruments to diagnostic tools.
Under his leadership, the CDRH has pursued initiatives aimed at streamlining the approval process for devices, promoting innovation, and enhancing patient safety; however, critics have raised concerns over what they see as a lack of transparency and potential conflicts of interest within the FDA’s decision-making processes.
One of the main points of contention is the FDA’s fast-tracking of certain high-risk medical devices, which some claim have not undergone adequate safety testing. The FDA’s 510(k) process, a pathway that allows devices to be approved based on their similarity to existing products, has come under fire for allowing potentially unsafe devices to reach the market.
In recent months, news articles have surfaced about Dr. Shuren. On July 28, 2024, Dr. Jeff Shuren stepped down as Director of the CDRH, ending 15 years as the FDA official in charge of medical device industry regulation.
An article published on August 20, 2024 in the New York Times titled “He Regulated Medical Devices His Wife Represented Their Makers,” highlighted the controversy surrounding the former Director of the FDA's CDRH and centers on conflict of interest allegations. During his tenure, Shuren oversaw the approval of many medical devices, while his wife, Allison Shuren, worked at a law firm that represented some of the companies making those devices.
One of the most significant issues involved breast implants. According to the report, Ms. Shuren’s firm “was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.” Months later, Dr. Shuren and another official reversed course and urged a recall, “citing additional reports of injuries and deaths related to the lymphoma.” Critics say this delay of the recall put more patients at risk.
The FDA has stated it found no evidence that the former director violated criminal conflict of interest laws however this has raised ethical concerns as critics argue that he did not always properly recuse himself from decisions involving companies his wife's firm represented. These potential conflicts of interest raise important questions about the FDA's transparency and accountability and the impact on patient safety.
Dr. Daniel Schultz, Director of CDRH 2004 - 2009
Dr. Daniel Schultz was in charge before Dr. Jeff Shuren. Starting in 2004, Schultz led the CDRH for five years but faced increasing scrutiny over his approval of controversial medical devices. The debate around Dr. Schultz centered on allegations that he pressured scientists to approve medical devices despite concerns about their safety and effectiveness.
The most notable case involved the Menaflex knee implant, which Schultz approved over staff objections after political pressure. In 2008, eight FDA scientists accused CDRH managers of coercing staff into approving unsafe devices, prompting a Congressional investigation into the agency’s practices. This led to internal conflicts, with FDA scientists questioning the integrity of the approval process.
Schultz resigned in 2009 amid growing criticism. His departure prompted a re-evaluation of how medical devices were approved, highlighting broader issues of balancing innovation with public safety. Much of this controversy was highlighted in the 2023 article, “The Year Turmoil Erupted at CDRH.”
Controversies at the FDA's CDRH, including issues with device approvals and regulatory oversight, have potentially had an impact on breast implants. Potential conflicts of interest raise critical concerns about the FDA's commitment to transparency and maintaining accountability in its decision-making processes. When regulatory leaders have close ties to the industries they oversee, it can lead to a perception—or worse, a reality of compromised decision-making.This can erode public trust in the FDA, as patients and healthcare providers may become wary of the agency's ability to prioritize safety over industry profits. These controversies highlight potential gaps in the safety monitoring and approval processes of medical devices, which reinforces the concerns continued to be raised by BISA.
Going Forward
Patients and consumers need accurate data to make informed healthcare decisions. Lack of data and transparency has been an ongoing issue with breast implants. “Women deserve these facts. Without them, there is no real choice,” said Kim Gandy, president of the National Organization for Women during the FDA approval of silicone breast implants in 2005.
“We always worried innovation was coming at the expense of safety and I hope that they are weighed more equally than they have been during his tenure. If the FDA is to welcome innovation and move devices to market more quickly, then they need to act just as quickly when a product needs to be recalled,” says BISA’s data specialist CEO of Device Events, Madris Kinard.
The practice of medicine has changed and in order for the FDA to keep pace, they need to update regulations and policies that have become outdated. For example, the definition of a User Facility does not include physician's offices. These offices are explicitly exempted from reporting adverse events.
Madris Kinard explains, “Breast implants were once the single most reported device by hospitals. Many of the procedures done now have moved to physician’s offices so there is a gap where data used to exist. This change started before the Covid pandemic but has been more substantial since. Requiring physicians' offices to be mandated to report would provide a wealth of data. Currently, only 1% of physician adverse event reports go directly to the FDA. When physicians don't report directly, the FDA has no way of updating the reports or providing critical labs and images that can help the FDA better understand the issues at hand.”
“If the FDA is to welcome innovation and move devices to market more quickly, then they need to act just as quickly when a product needs to be recalled.”
Time to Build Trust
To build trust with patients and consumers, BISA believes the new FDA CDRH Director must prioritize the avoidance of all actual and perceived conflicts of interest. BISA has been advocating for more transparency, stronger oversight, better communication, and accurate long-term safety data. FDA’s regulations and policies need to be revised to meet changes in medical practice. By focusing on these areas, the new Director can show a commitment to public health and safety, helping to restore confidence in the FDA’s ability to regulate medical devices responsibly.
References & Resources
New York Times: FDA Names a New Chief of Medical Devices
MassDevice: DA CDRH Director Jeff Shuren announces retirement
New York Times: Regulated Medical Devices His Wife Represented Their Makers
New York Times: Lawmakers Seek Inquiry of F.D.A. Device Chief’s Potential Conflicts
BioPharmaDive: Lawmakers call for investigation of former FDA device director
A Discussion of Conflicts of Interest in Plastic Surgery and Possible Remedies
How Conflict Of Interest Harms Patients: The Case Of FDA’s Dr. Jeffrey E. Shuren
MassDevice: FDA’s Shuren faces ethics questions in NYT report
New York Times: Breast Implants Linked to Rare Cancer Are Recalled
MedTechDive: FDA defends Shuren’s tenure after report raises ethics concerns
Fortune: Why are breast implants still putting millions of women at risk?
Fortune: Women with breast implants deserve to know more about what’s in their bodies
Public Citizen: Outrage of the Month: a Senior FDA Official Regulated Medical Devices While His Wife’s Law Firm Represented Their Manufacturers
Public Citizen: Letter to the Inspector General of the Department of Health and Human Services requesting an Investigation of Conflict of Interest Allegations Against a Senior FDA Official
STAT News: Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients
Shuren Faces Calls for Investigation on Conflict of Interest Claims
New York Times: Head of F.D.A. Division, Under Scrutiny, Resigns
Wall Street Journal: FDA Medical-Device Regulator Resigns
MassDevice: FDA device chief Schultz to step down
Reuters: FDA devices chief steps down
MDDI Online: The Year Turmoil Erupted at CDRH
MedTech Dive: 6 ways the FDA can improve medical device recalls
MedTechDive: Tarver, acting CDRH director, sets tone for future of the device center
BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees
FDA: Advisory Committees Give FDA Critical Advice and the Public a Voice
FDA: Learn About FDA Advisory Committees
The Future Of FDA Advisory Committees: Protecting Public Health And Preserving Public Trust
About Breast Implant Safety Alliance (BISA)
The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.
Contact: Maria Gmitro, President | maria@bisanonprofit.org