Breaking News
April 18, 2019 - Diabetic drug shows potential to be repurposed as heart disease treatment for non-diabetic patients
April 18, 2019 - New estimation method assesses natural variations in sex ratio at birth
April 18, 2019 - UTA scientist receives $1.17 million grant for cancer research
April 18, 2019 - Coagulation factor VIIa prevents bleeds in hemophilia animal models
April 18, 2019 - Researchers identify risk factors for severe infection after knee replacement
April 18, 2019 - Mass drug administration can offer community-level protection against malaria
April 18, 2019 - FDA’s added sugar label could have substantial health and cost-saving benefits
April 18, 2019 - Researchers identify cause of inherited metabolic disorder
April 18, 2019 - Single strip of white paint not sufficient to protect people who ride bikes
April 18, 2019 - Partner status influences link between sexual problems and self-efficacy in breast cancer survivors
April 18, 2019 - Colorectal Neoplasia Risk Up for Hodgkin Lymphoma Survivors
April 18, 2019 - Rigid spine muscular dystrophy – Genetics Home Reference
April 18, 2019 - Simple bile acid blood test could tell risk of stillbirth
April 18, 2019 - Center for Experimental Therapeutics aims to enable all steps of drug development | News Center
April 18, 2019 - Falling for telephone scams could be an early sign of dementia
April 18, 2019 - Researchers annotate key neuronal proteins in lamprey genome
April 18, 2019 - Study uncovers new biomarker for personalized cancer treatments
April 18, 2019 - Scientists enter research collaboration to find a cure for cancer
April 18, 2019 - Study to compare benefits of tai chi and mindfulness meditation on MS symptoms
April 18, 2019 - Gestational diabetes during pregnancy may increase risk of type 1 diabetes in children
April 18, 2019 - Is a New Remedy for Body Odor on the Horizon?
April 18, 2019 - Orthostatic hypotension – Genetics Home Reference
April 18, 2019 - Healing the heartbreak of stillbirth and newborn death
April 18, 2019 - Conference to highlight advances in human immune monitoring, bioinformatics | News Center
April 18, 2019 - Bacteria use viruses for self-recognition, study reveals
April 18, 2019 - New adhesive patch could help reduce post-heart attack muscle damage
April 18, 2019 - Researchers analyze the effects of dark play in a serious video game
April 18, 2019 - Filial cannibalism and offspring abandonment may be forms of parental care
April 18, 2019 - Two proteins act in concert to maintain a healthy heart in mice, shows study
April 18, 2019 - Scientists create a functioning 3D printed heart
April 18, 2019 - Non-invasive vagus nerve stimulation improves disease symptoms in patients with rheumatoid arthritis
April 18, 2019 - Majority of men struggle to understand diagnosis and treatment of prostate cancer
April 18, 2019 - Researchers create new small molecules that may combat equine encephalitis viruses
April 18, 2019 - Animal-assisted therapy improves social behavior in patients with brain injuries
April 18, 2019 - Some viruses help protect harmful bacteria in CF patients | News Center
April 18, 2019 - Outpatient healthcare providers inappropriately prescribe antibiotics to 40% of patients
April 18, 2019 - Men who have a resting heart rate of 75 bpm are twice as likely to die early
April 18, 2019 - Novel serum biomarkers to detect NAFLD-related fibrosis
April 18, 2019 - New study delves deeper into individual genomic differences than ever before
April 18, 2019 - Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
April 18, 2019 - Emotional mirror neurons found in rats
April 18, 2019 - Sylvia Plevritis appointed chair of biomedical data science | News Center
April 18, 2019 - Yeast strain provides manufacturing boost to low-calorie sweetener derived from lactose
April 18, 2019 - One in five children and youth suffer from a mental disorder
April 18, 2019 - Improper inhaler use common in children with asthma
April 18, 2019 - C-Path and CDISC release global Therapeutic Area Standard for HIV research
April 18, 2019 - Integrating AI to analyze imaging data allows early recognition of heart disease
April 18, 2019 - Low-cost, high-speed algorithm may allow animal-free chemical toxicity testing
April 18, 2019 - HPV-negative cervical cancers are more aggressive with worse prognosis
April 18, 2019 - AI detects prostate cancer with same level of accuracy as experienced radiologists
April 18, 2019 - Study resolves sex differences in psychiatric illness risk
April 18, 2019 - Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
April 18, 2019 - Cocktail of common antibiotics can fight resistant E. coli
April 18, 2019 - Persis Drell to give keynote address at medical school diploma ceremony | News Center
April 18, 2019 - EpicTogether: Remembering Our Why
April 18, 2019 - Study identifies novel loci contributing to asthma susceptibility in adults
April 18, 2019 - Gut bacteria and pregnancy
April 18, 2019 - New study finds that screening could help prevent rare types of cervical cancer
April 17, 2019 - Spatial orgnization of the genome can be altered using small molecules
April 17, 2019 - AEDs Tied to Higher Pneumonia Risk in Alzheimer Patients
April 17, 2019 - Telemedicine tied to more antibiotics for kids, study finds
April 17, 2019 - Two medical students awarded 2019 Soros Fellowships for New Americans | News Center
April 17, 2019 - Sociologist Constance A. Nathanson Awarded Guggenheim Fellowship
April 17, 2019 - Empathy and hormones could account for aggressive behavior in children, shows study
April 17, 2019 - Researchers develop oral appliance to help sufferers of sleep apnea
April 17, 2019 - Neuronal transport factor detects its target transcripts in more complex manner than previously thought
April 17, 2019 - New drug-delivery system senses high oxidant levels, responds to body chemistry and environment
April 17, 2019 - Health Tip: Horseback Trail Riding Safety
April 17, 2019 - Scientists outline the promises and pitfalls of machine learning in medicine
April 17, 2019 - $12 million grant renewal for flu vaccine research | News Center
April 17, 2019 - Lisa Kachnic, MD, Joins Columbia University as Chair of Radiation Oncology
April 17, 2019 - New study sheds light on how extreme temperature hampers spermatogenesis in insects
April 17, 2019 - Study tests high-tech, non-pharmaceutical way to address ADHD and distractibility
April 17, 2019 - New EZ-2 evaporator for clinical biochemistry sample preparation
April 17, 2019 - Fat shaming celebrities may make women more judgemental about being overweight
April 17, 2019 - Magic mouthwash effectively reduces mouth sore pain caused by radiation therapy
April 17, 2019 - CBD could help slip medications into the brain
April 17, 2019 - Scientists characterize 2017 pneumonic plague outbreak in Madagascar
April 17, 2019 - Human iPSC-derived MSCs from aged individuals acquire a rejuvenation signature
April 17, 2019 - Gun Research Is Suddenly Hot
FDA warns two breast implant makers for failure to comply with post-approval study requirements

FDA warns two breast implant makers for failure to comply with post-approval study requirements

image_pdfDownload PDFimage_print

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633890.htm

Tagged with:

About author

Related Articles