Cochlear Implants

… Cochlear implants are electronic hearing devices. Doctors implant cochlear implants into people with severe to profound hearing loss to … sensations. The FDA regulates manufacturers of cochlear implants. For manufacturers to sell cochlear implants in the …

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

… implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. … implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, …

Metal-on-Metal Hip Implants

… or hip resurfacing. There are several types of hip implants including total hip replacement, hip resurfacing, … include metal-on-metal articulation and how metal-on-metal implants differ from other hip implants and recommendations for patients and health care …

Breast Implants

… communication and help those who are considering breast implants make informed decisions.   These actions include … orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that …

What to Know About Breast Implants

… carcinoma (SCC) in the scar tissue (capsule) around breast implants. The March 2023 communication updates the September … talk with people who have or are considering breast implants about SCC and various lymphomas in the capsule around breast implants.  The FDA continues to ask health care providers and …

Concerns about Metal-on-Metal Hip Implants

… All artificial hip implants carry risks including wear of the component material. Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants . In MoM hip implants, the metal ball and the metal …

Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

… Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication for the latest … in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as … reports through our continual postmarket review of breast implants and our ongoing collaboration with external …

Benefits and Risks of Cochlear Implants

… On this page: What are the Benefits of Cochlear Implants? What are the Risks of Cochlear Implants? General Anesthesia Risks Risks from the Surgical … Procedure Other Risks Associated with the Use of Cochlear Implants What are the Benefits of Cochlear Implants? For …

Urogynecologic Surgical Mesh Implants

… The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine). Uses for … Health … The home page for Urogynecologic Mesh Surgical Implants that describes the implants. … Medical Devices … Urogynecologic Surgical Mesh …

FDA-Approved Cochlear Implants

… Food and Drug Administration has approved several cochlear implants for sale in the US. Many of the original implants approved by FDA are no longer implanted in patients … and their features. Search for all FDA-approved cochlear implants in the nearby Search Cochlear Implants link. FDA's …

Dental Implants: What You Should Know

… Dental implants are medical devices surgically implanted into the … System Recommendations for Patients Before choosing dental implants, talk to your dental provider about the potential … in determining whether you are a good candidate for dental implants, how long it will take to heal, and how long the …

Temporomandibular Joint (TMJ) Implants

… Temporomandibular joint (TMJ) implants are intended to be surgically implanted in the jaw … a combination of these materials. On this page: About TJM Implants Candidates for TMJ Implants Problems Reported with TMJ Implants Recommendations …

FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants

… Drug Administration issued the final guidance, “ Breast Implants - Certain Labeling Recommendations to Improve … and health care professionals about the risks of breast implants. The draft guidance of this document was issued in … available about the risks and complications of breast implants, it is critical that women have access to …

Risks and Complications of Breast Implants

… The FDA has updated  the Risks and Complications of Breast Implants, clarifying information about Implant Removal and … communication and help those who are considering breast implants make informed decisions. These actions include … orders restricting the sale and distribution of breast implants to help ensure that patients considering breast …

Types of Breast Implants

… On this page: Saline-Filled Breast Implants Silicone-Filled Breast Implants Summary Breast Implants Safety Information Breast Tissue Expanders More …

FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants

… communication and help those who are considering breast implants make informed decisions. First, the agency issued … orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that …

FDA Backgrounder on Platinum in Silicone Breast Implants

… of the shell and gel components of silicone breast implants. Because small amounts of platinum remain in the … studies on platinum in silicone gel-filled breast implants. STUDIES INCLUDED IN THE 2000 INSTITUTE OF MEDICINE REPORT ON THE SAFETY OF SILICONE GEL BREAST IMPLANTS In 2000, the Institute of Medicine (IOM) published …

Cochlear Implants and MRI Safety

… the risks that an MRI may pose to patients with cochlear implants, take precautions to avoid these risks, and report … may occur in the MRI environment. On this page: MRIs and Implants Containing Metal or Magnets Cochlear Implant Patient Implant Card Cochlear Implants and MRI Safety Adverse Events Associated with …

General Information about Hip Implants

… Hip implants are medical devices intended to restore mobility and … is typically successful, it is important to know that hip implants may need to be replaced eventually. Materials Used in Hip Implants In the United States, there are currently four types …

Metal-on-Metal Hip Implants: Information for Patients

… Information for Patients who have Metal-on-Metal Hip Implants How do I know if I have a metal-on-metal hip … I get additional information regarding metal-on-metal hip implants? Information for Patients Considering a … I ask my orthopaedic surgeon about metal-on-metal hip implants? Which patients should not have a metal-on-metal hip …

FDA's Role in Approving TMJ Implants and Monitoring Their Safety

… helping to ensure the safety FDA's Role in Approving TMJ Implants and Monitoring Their Safety and effectiveness of … Disorder (TMD), such as Temporomandibular Joint (TMJ) implants. The FDA reviews TMJ implants before they are marketed and continues to monitor …

Update on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary

… PDF Print Version Breast implants are medical devices that are used to augment breast … mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most … Approximately 5 to10 million women worldwide have breast implants. According to the American Society of Plastic …

Effectiveness of Metal-on-Metal Hip Implants

… own benefits and risks. Overall, metal-on-metal (MoM) hip implants have been shown to provide high implant survivorship … In addition, the larger head size of MoM total hip implants is intended to reduce the risk of dislocation, which … a conventional primary femoral component. Hip resurfacing implants are only available with metal-on-metal (MoM) …

Sientra’s Silicone Gel Breast Implants (Premarket application number: P070004) (Approved March 2012)

… Detailed Information Links: Sientra’s Silicone Gel Breast Implants have a silicone outer shell that is filled with … studies for Sientra’s silicone gel-filled breast implants included: Core Cohort Study - To assess long-term clinical performance of breast implants in the 1,788 women that enrolled in studies to …

Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants

… a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the … neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) …