The Food And Drug Administration has found that the maker of the popular Invisalign invisible braces failed to inform the agency about allergic reactions to the product. Some of these allergic reactions were serious enough to be life-threatening.
According to the Food and Drug Administration, it first learned about these allergic reactions this year. The agency has sent the company that manufactures Invisalign, Align Technology, a warning letter, alleging that the company failed to inform the agency about how it was going to enhance its reporting procedures. Align Technology has issued a news release saying that it did, in fact report, these incidences of allergic reactions to the FDA.
The FDA letter describes certain serious symptoms that patients who used the braces suffered:
On November 2, 2007, one patient reported severe gum and lip irritability. The lips and gums became swollen, red, sore and irritable. There were several other such reports that were made to the FDA, and some of these cases were serious enough to require hospitalization of the patient.
As recently as May 11, 2010, there was another report of allergic reactions from using the braces. This patient suffered a burning tongue sensation. The patient also reported soreness in the throat, mouth ulcers as well as swollen lymph nodes.
The warning letter does not caution patients about the allergic reaction from Invisalign braces. It does however, chide the company for failing to bring the reports of allergic reactions to the agency’s notice.
As an Atlanta dental malpractice lawyer, I keep myself updated about the latest innovations and technologies in dentistry. There is no doubt that this is a burgeoning field, with new techniques and devices being introduced regularly. For instance, Invisalign braces that promised to take the humiliation out of wearing braces, have quickly become popular.
According to Align Technology, these braces have been used in approximately 1.3 million patients. It’s enough to make you wonder, how many of these persons suffered side effects, and were unaware that these were caused by the braces. However, based on the laws regarding dental malpractice in Georgia, there does not appear to be a strong basis for bringing dental malpractice cases for the use of Invisalign. In Georgia, the patient must prove all of the following four elements of a malpractice claim: (1) – the existence of a duty, usually implied by the doctor-patient relationship; (2) – a breach of the duty — in malpractice, a breach of the standard of care; (3) damages — in other words, an injury; and (4) causation — a causal connection between the failure to meet the standard of care and the resulting injury. Simply relying on the use of Invisalign vs. more traditional methods for orthodontic care, will not, in most cases, support this type of evidentiary burden.
Robert J. Fleming has been handling wrongful death cases, dental malpractice, bus accidents, car accident cases and premises injury cases for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 20 years. He practices in and around the Atlanta, Georgia area including handling lawsuits in Fulton, DeKalb, Clayton, Gwinnett, Cobb and other counties and nearby cities including Alpharetta, Austell, Avondale Estates, Chamblee, College Park, Conyers, Duluth, Decatur, Doraville, Hapeville, Johns Creek, Jonesboro, Lawrenceville, Norcross, Peachtree City, Riverdale, Roswell, Sandy Springs, Stone Mountain, and Smyrna. If you have been seriously injured and would like discuss your case, contact Robert J. Fleming directly on (404) 525-5150 or contact us online.