Earlier this month, the Food and Drug Administration (FDA) issued a warning regarding
two breast implant manufacturers for their failure to comply with specific regulatory requirements. According to the official FDA press release, the FDA sent warning letters to Allergan and Ideal Implant Incorporated.
The Warning Letters
Under United States regulations, the manufacturers of silicone breast implants must conduct studies to ensure the continued safety of their products, even after the product has obtained FDA approval. According to the FDA, these post-approval studies are designed to “further evaluate the 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.”
Notably, the FDA requires this follow-up testing even if the manufacturer voluntarily recalls a product. These post-approval studies are crucial to evaluate the continued safety of recalled breast implants for those who already have had the devices implanted.
This is precisely what happened in the case of Allergan. Last year, Allergan voluntarily recalled two models of breast implants. Those models were:
- NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants, and
- NATRELLE Silicone Gel-Filled Breast Implants
Evidently, the FDA sent Allergan the warning letter after discovering that the post-approval studies were not being conducted according to FDA regulations. The FDA gave Allergan 15 days to correct the violation, indicating that additional enforcement would follow if the company took no action.
Regarding the warning letter issued to Ideal Implants, the FDA noted that the company had not provided adequate information regarding customer complaints, and, in instances of a withdrawn complaint, what led customers to withdraw their complaints.
Medical Device Product Liability Claims
Breast implants are just one of many medical devices that, over recent years, have been discovered to have caused harm to patients. For example, the FDA lists the following as potential health concerns related to breast implants:
- Implant complications, such as breast pain and changes in nipple and breast sensation
- Additional surgeries, with or without removal of the device (also see Implant Removal Options)
- Scar tissue that forms around the implant and squeezes the implant
- Rupture and deflation
- Anaplastic large cell lymphoma, which is a type of non-Hodgkin’s lymphoma (cancer of the immune system)
- Connective tissue disease, breast cancer, and reproductive problems
- Concerns regarding breastfeeding
Of course, the manufacturers of breast implants and other medical devices have a duty to patients to ensure that their product is designed and manufactured in a safe manner, and that all known risks are made known to the patient. If companies fail to take these steps, they may be held liable for any complications, illnesses, or injuries suffered by the patient.
Have You Been Harmed by a Defective Medical Device?
If you or a loved one has recently discovered that a medical device resulted in any type of illness or injury, you may be entitled to monetary compensation. At Moll Law Group, we represent patients who have been injured due to defective and dangerous medical devices. Our dedicated team of product liability attorneys have extensive experience handling even the most complex Illinois product liability cases, and know what it takes to succeed on our clients’ behalf. We routinely work with well-respected medical experts nationwide to help prove our clients’ claims. To learn more, call 312-462-1700 to schedule a free consultation today.