As the FDA weighed its expansion of the summary reporting program earlier this year, Cook and a dozen other patients with medical device problems, along with the patient-advocacy group Public Citizen, urged the agency to rethink its plan. Its breast implants are manufactured with long-term implantable medical grade silicone supplied from an ISO certified source. Global Breast Implants Market Their portfolio of superior medical devices includes more than 1, variations of breast implants for women, soft-tissue implants for men as well as calf and gluteus implants. That can lead to underreporting, along with missing and flawed data.
The regulatory history of breast implants
Several reports have concluded that there is no evidence that implants cause systemic disease. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: Although mammography can be performed in ways that minimize the interference of the implants, approximately 55 percent of breast tumors will be hidden in women with implants.